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Improving Pneumococcal Vaccine Utilization in Long Term Care Facilities

ABSTRACT

The Centers for Disease Control and Prevention (CDC) reports that pneumococcal pneumonia and invasive pneumococcal disease, including bacteremic infection and meningitis, affect more than 500,000 individuals each year in the United States. Several groups are considered to have an increased risk of pneumococcal disease and are more likely to be hospitalized and die as the result of such infections: people who are 65 years of age or older; people with chronic underlying conditions such as chronic obstructive pulmonary disease, cardiovascular disease, and diabetes; and people with significant immune system impairments. Despite these statistics, pneumococcal disease awareness remains low in North America: one study indicated that fewer than 43% of adults are aware that any type of pneumonia can be prevented by a vaccine. Health care providers, therefore, have a significant responsibility to proactively recommend vaccines to patients and their caregivers.

The CDC's Advisory Committee on Immunization Practices has made specific recommendations regarding administration of pneumococcal vaccines in patients older than 65 years of age and in those with certain underlying conditions. The most recent data from the CDC indicate that, while rates of vaccination with at least 1 of the 2 recommended vaccines have improved over the past 20 years in these populations, the number of patients remaining unvaccinated is substantial. Additionally, in long–term care (LTC) facilities, despite federal requirements to offer pneumococcal vaccines that are tied to reimbursement, many residents are not being offered vaccines or documentation is incomplete. The goal of this manuscript is to offer evidence–based recommendations on how pharmacists can assist in improving vaccination rates in LTC facilities.

INTRODUCTION

The Pew Research Center estimates that 10,000 people attain the age of 65 years every day in the United States (U.S.), and this trend is expected to continue through 2020 due to the aging of the "Baby Boomer" generation.1 Despite the fact that members of this age group generally perceive themselves to be 9 years younger than their true chronological age, individuals over the age of 65 years are more likely to use health care resources than younger generations. The Centers for Disease Control and Prevention (CDC) reports that approximately 67,000 paid and regulated long–term care (LTC) service providers in the U.S. cared for more than 9 million patients in 2014. People over the age of 65 years represent the majority of individuals served by these providers (Table 1),2 and this trend is expected to continue into the next decade. With the growth in the aging population, as well as the expansion of care provided in LTC settings, including nursing homes, hospice, adult day care, and other settings, it is critical for health care providers to consider the immunization needs of this population.

Table 1. Percent of Long-term Care Service Users Who are Aged 65 Years and Older According to Setting or Care Provider2
Setting Percent of patients aged 65 years or older Year of most recent data
Adult day care centers 63.7 2014
Home health agencies 82.6 2013
Hospice 94.4 2013
Nursing homes 84.9 2014
Residential care communities 92.9 2014

PNEUMOCOCCAL DISEASE

An analysis by the CDC identified the infectious lung diseases of influenza and all–cause pneumonia as the 8th leading cause of death in individuals aged 65 years or older in 2015, with more than 48,000 deaths attributable to these infections; this number has remained relatively unchanged since 1980.3 Streptococcus pneumoniae, commonly referred to as pneumococcus, is a gram–positive anaerobic bacterium that is most commonly (but not exclusively) observed in pairs (diplococcus). The bacteria cause a wide range of clinically important infections, collectively known as pneumococcal disease, that range from the generally mild sinusitis and otitis media to the severe and potentially life–threatening bacteremia and meningitis. There are more than 90 known serotypes, or capsular polysaccharide configurations, of S. pneumoniae, but only 30 to 35 of them are known to cause clinically significant human infections. Each of the serotypes engages with the human immune system to elicit a unique, serotype–specific, T–cell–independent immune response. There is no known cross–immunogenicity among serotypes, save for Types 6A and 6C, which means that individuals who have contracted a pneumococcal infection caused by 1 serotype in the past remain susceptible to future pneumococcal infections with other serotypes.4

Bacteremia and meningitis, together referred to as invasive pneumococcal disease (IPD), are often the focus of acute health care provider concerns: an estimated 34,000 cases and 3700 deaths were attributable to IPD in 2013. Most (69%) IPD cases involve patients who have pneumonia with bacteremia. As shown in Table 2, the incidence of IPD is greater in persons aged 50 years or older than in younger persons. Similarly, the risk of death from IPD is significantly higher in older adults. However, notwithstanding the seriousness of IPD, the major burden of disease from S. pneumoniae infection in the U.S. is community–acquired pneumonia (CAP).5

Table 2. Incidence of Invasive Pneumococcal Disease According to Age, 20155
Age (years) Cases, n (rate)* Deaths, n (rate)*
<1 77 (18.4) 1 (0.24)
1 54 (12.9) 1 (0.24)
2-4 65 (5.1) 2 (0.16)
5-17 70 (1.3) 0 (0.00)
18-34 179 (2.5) 6 (0.08)
35-49 416 (6.7) 31 (0.50)
50-64 924 (15.0) 94 (1.53)
65-74 497 (18.2) 62 (2.30)
75-84 379 (29.0) 59 (4.50)
≥85 282 (45.3) 72 (11.56)
Total 2943 (9.2) 329 (1.03)
*Per 100,000 persons in active bacterial core surveillance areas.

Pneumococcal disease in older adults

The term "long–term care" encompasses a broad range of care situations, including hospice care, skilled nursing facilities, nursing homes, adult day care facilities, and other assisted living environments, but much of the literature regarding the incidence, prevalence, morbidity, and mortality related to pneumonia in LTC facilities is restricted to the nursing home environment. For example, Polverinand colleagues6 reported the experiences of a single nursing home and evaluated whether nursing home–acquired pneumonia (NHAP) was similar to CAP or if it should be considered a separate category of infection. The authors' conclusions were that nursing home patients have multiple complex comorbidities and that the most common isolates in patients with pneumonia were S. pneumoniae (58%), Enterobacteriaceae (9%), atypical bacteria (7%), and respiratory viruses (5%). These findings are aligned with the microbiologic patterns of CAP and can generally be treated empirically, with some patient– specific exceptions being recommended.6

A meta–analysis by File and Marrie7 documented that, among all adults in the U.S., there were approximately 4.2 million ambulatory care visits for pneumonia in 2006 and more than 60,000 deaths due to pneumonia in persons older than 15 years of age; the largest number of deaths occurred in those aged 65 years or older. Hospitalization rates increased over the analysis period to 1667 per 100,000 persons, with a mean length of stay of 6 days for all–cause pneumonia. More recently, when evaluating the cost–effectiveness of vaccination, the CDC has utilized assumptions estimating a hospitalization incidence of 1375 per 100,000 in people over age 65 years. File and Marrie observed a 30–day rehospitalization rate exceeding 20%, and mortality was highest among those who were hospitalized.7

Each year, the CDC reports approximately 400,000 hospitalizations from pneumococcal pneumonia in the U.S. Not surprisingly, according to the CDC, individuals who are older than 65 years of age are more likely to be hospitalized and are more likely to die from pneumonia than younger patients. Additionally, older patients and those who are in LTC facilities who have been hospitalized with pneumococcal pneumonia are more likely to be readmitted to the hospital within 30 days of discharge, with as many as 30% of nursing home patients being readmitted following a pneumococcal pneumonia infection. The Centers for Medicare and Medicaid Services (CMS) announced that, beginning in October 2018, skilled nursing home payment rates will be directly tied to rehospitalization statistics, including rates of rehospitalization for patients with pneumonia.8,9 As presented in more detail later in this monograph, the importance of preventing pneumonia through effective vaccination strategies will be extremely important given the new financial incentives.4

Between 1997 and 2009, all–cause pneumonia was responsible for 17,892,085 hospitalizations. Data analysis showed that the incidence of hospitalization was highest at the ends of the age spectrum, with rates for those younger than 2 years old being approximately the same as for those 65 to 74 years old: both age groups experienced approximately 1000 hospitalizations per 100,000 persons. However, rates for individuals 75 years or older were 5 times higher, reaching nearly 6,000 hospitalizations per 100,000 persons.10

While it is generally accepted that 20% to 60% of CAP is caused by S. pneumoniae, the hospitalization data analysis showed that very few hospitalizations actually list pneumococcus as the causative organism.10 Nonetheless, most reliable sources confirm that S. pneumoniae continues to be the most frequently identified pathogen associated with CAP, including NHAP.4,7 A more recent European meta–analysis by Welte and colleagues11 provides a glimpse into the global problem of pneumococcus in the older adult population: the authors found that CAP occurred more frequently in individuals aged 65 years or older, with S. pneumoniae being the most commonly isolated microbe.11 However, pneumococcal disease does not only affect older adults: the World Health Organization and the Sabin Institute report that pneumococcal disease is the single largest vaccine–preventable cause of death among children, causing nearly 500,000 deaths globally each year in children aged 5 years or younger.12,13

While general age–based analyses of the incidence of pneumococcal disease have provided useful information, some studies have examined subsets within the aging population. For example, an analysis of Alaska Native adults aged 55 to 70 years identified a rate of IPD in that population of 80.9 cases per 100,000 persons, which is approximately double the incidence in the general American population.14 These data parallel epidemiologic observations from the CDC of an increased incidence of pneumococcal infection in certain ethnic minority children, as well, with Alaska Native, African American, and American Indian children having an unexplainable increased rate of infection.4

Altogether, the CDC assumes a rate of infection indicating that S. pneumoniae serotypes account for approximately 36% of all CAP cases in adults. As many as 25% to 30% of patients with pneumococcal pneumonia will also develop bacteremia; another 12,000 cases of pneumococcal bacteremia occur each year without pneumonia. The case–fatality rate for pneumococcal pneumonia is 5% to 7% among all adults, but it may be significantly higher among adults over 65 years of age. The case–fatality rate for pneumococcal bacteremia without pneumonia is 20% for all adults but is as high as 60% in patients older than 65 years of age. Chronic underlying diseases, such as lung, heart, renal, or hepatic disease, as well as the presence of immunocompromising conditions, such as neoplasms, leukemia, lymphoma, solid organ transplant, HIV/AIDS, asplenia, and iatrogenic immunosuppression, can all increase both the risk of contracting pneumococcal pneumonia and the risk of being hospitalized from the disease.4

PNEUMOCOCCAL VACCINES

Research to develop a pneumococcal vaccine began in South Africa in 1911. However, the advent of penicillin, which at the time of its discovery was extremely effective at treating pneumococcal disease, caused researchers to lose some interest in developing vaccine candidates that were more reliable than the original whole–cell products available in the early 1900s. For the next nearly 50 years, the pharmaceutical market was marked by an absence of pneumococcal vaccine of any kind. In the late 1960s, the National Institutes of Health and pharmaceutical manufacturer researchers regained interest in preventing pneumococcal infections when a 30% case–fatality rate was observed, despite available antibiotic therapy.15

Pneumococcal polysaccharide vaccine

The first vaccine for pneumococcal disease was licensed for use in the U.S. in November 1977, and the first Advisory Committee on Immunization Practices (ACIP) recommendations for routine use of the vaccine were published in 1978. This vaccine was a purified polysaccharide capsular vaccine that provided immunogenicity against 14 specific serotypes of S. pneumoniae; it was recommended for routine use in high–risk individuals with chronic underlying conditions 2 years of age or older. The currently available 23–valent pneumococcal polysaccharide vaccine (PPSV23; Pneumovax; Merck & Co. Inc.) was first licensed in 1983 following controlled clinical trials in response ta desire by public health officials around the world to cover a broader number of circulating serotypes that cause pneumococcal disease. In 1984, the ACIP made its first recommendation for use of the vaccine in individuals 65 years of age or older.15 Currently, PPSV23 is approved by the U.S. Food and Drug Administration (FDA) for use in persons 50 years of age or older and in persons aged 2 years of age or older who are at increased risk of pneumococcal disease.16

Pneumococcal polysaccharide vaccine efficacy

An analysis of pneumococcal isolates submitted to the CDC between May 1978 and April 1992 examined the efficacy of polysaccharide vaccines at preventing serious pneumococcal infection (bacteremia or meningitis) in patients who generally had substantial chronic underlying conditions or immunocompromising conditions or who were over 65 years of age. The analysis showed that the vaccines had an overall efficacy of 57% for IPD, with higher efficacy in patients with diabetes (84%), cardiovascular disease (73%), congestive heart failure (69%), and anatomic asplenia (77%). There were no statistically significant differences in efficacy among patients with alcoholism or cirrhosis, sickle cell disease, leukemia or lymphoma, multiple myeloma, or chronic kidney disease, though the authors noted that the sample sizes for these populations were very small and they may have not been able to detect a difference due to this limitation.17

As mentioned previously, there is a paucity of data regarding pneumococcal vaccine efficacy for patients receiving LTC. A study in 2010 examined the efficacy of PPSV23 in preventing pneumonia and improving survival in nursing home residents in Japan.18 The primary end points of the study were the occurrence of all–cause pneumonia and the occurrence of pneumococcal pneumonia. The study found that both all–cause pneumonia and pneumococcal pneumonia occurred at significantly lower rates in the PPSV23 group than in the placebo group. Death due to pneumococcal pneumonia was also significantly lower in the pneumococcal pneumonia group than in the placebo group, but the difference was not significantly different in the all–cause pneumonia group compared to the placebo group. These results are promising and suggest that the PPSV23 vaccine is effective against pneumonia in a nursing home population. However, efficacy data are very limited otherwise and this study represents the only recent trial of pneumococcal vaccine use in an LTC setting.

Despite the success reported in the nursing home population, PPSV23 efficacy related to CAP has not been without controversy in the literature. The CDC addressed this issue when it published the ACIP's 2014 recommendations for the use of pneumococcal vaccines in persons aged 65 years or older: "Effectiveness of PPSV23 in preventing IPD in adults has been demonstrated, but the data on the effectiveness of this vaccine in preventing noninvasive pneumococcal pneumonia among adults aged greater or equal to  65 years have been inconsistent."19 This conclusion was drawn from agency data, as well as data presented in a Cochrane Library Review of randomized controlled trials examining pneumococcal vaccine efficacy against either IPD or pneumonia.20

Pneumococcal polysaccharide vaccine safety

The safety of PPSV23 has been well studied, and the vaccine is considered quite safe for use in all persons aged 2 years or older for whom the vaccine is indicated. Manufacturer safety studies show no statistically significant difference in serious adverse events between those who have received the vaccine and those who have not. Injection site pain and tenderness, swelling, and erythema are the most common localized reactions; headache, myalgia, fatigue, and chills are the most common systemic adverse events reported. The rate of both local and systemic adverse events increase with revaccination doses of PPSV23.16

Pneumococcal conjugate vaccine

Pneumococcal polysaccharide antigens evoke a serotype–specific, T–cell–independent immune response. For this reason, the vaccine is not immunogenic in persons younger than 2 years of age. T–helper cells, which are responsible for the release of cytokines from the immune system, and, in turn, engendering a larger response from the antibody–producing B–cells, are not activated by this vaccine. Because T–helper cells are not activated as part of exposure ta polysaccharide antigen, there is very little, if any, "booster" effect when subsequent doses of the vaccine are administered. Additionally, sufficient numbers of immunologic memory cells are not produced subsequent to initial antigen exposure, so, with time, efficacy wanes. This challenge with immunogenicity and long–term efficacy is overcome through a process known as "conjugation." Conjugation, in this case, involves the attachment of a molecule of diphtheria protein to the purified polysaccharide capsule segment of pneumococcus; this results in a shifting of the immune response ta T–cell–dependent activity, while still maintaining the serotype–specific response of the immune system.21

In 2000, the first pneumococcal conjugate vaccine, a 7–serotype vaccine (PCV7), was licensed in the U.S. In response to public health requests for broader serotype coverage, as with the first polysaccharide vaccine, the manufacturer developed a 13–serotype conjugate vaccine (PCV13; Prevnar–13; Pfizer, Inc.) to replace PCV7. PCV13 has significantly reduced the incidence of pneumococcal disease, particularly in pediatric populations, which has been extensively reviewed in the literature.19,22,23 Because the focus of this manuscript is on LTC residents, most of whom are older adults, the literature review in the remainder of this module will focus on adult populations.

Pneumococcal conjugate vaccine efficacy

Goldblatt and colleagues24 conducted an open–label, randomized study comparing PCV7 with PPSV23 in individuals 50 t80 years of age to identify which vaccine evoked the better immune response (immunogenicity). Participants received 1 dose of PCV7 or PPSV23, followed 6 months later by a second dose of PCV7 or PPSV23. Immunoglobulin G (IgG) levels for the serotypes were measured before vaccination, 4 to 6 weeks after vaccination, and 1 year after vaccination. There were approximately equal numbers of study participants in each decade– specific age group (i.e., 50–59 years old, 60–69 years old, 70–80 years old). The study, which included a total of 599 volunteers, found that serotype–specific IgG concentrations were approximately 10% lower for each 10 years of increasing age. Interestingly, 1 month after vaccination with a single dose of vaccine, serotype–specific IgG levels differed significantly for several serotypes: 4 of the 7 serotypes were higher in the PCV7 group and 1 of the shared serotypes was higher in the PPSV23 group. One year after administration of the second dose of vaccine, only 1 serotype had a significantly higher IgG concentration. The authors report no differences in IgG concentrations among the 3 decades of ages evaluated.24

The manufacturer of PCV13 conducted studies to compare the immunogenicity of PCV13 and PPSV23 to determine if an equivalent immune response was achieved by PCV13 for the shared serotypes, and if an expected immune response was achieved for the serotype unique to PCV13, in adult patients. These studies found non–inferior immune responses for all of the shared serotypes across all adult age ranges (i.e., 19–49 years old, 50–59 years old, 60–64 years old) for vaccine–naïve patients and non–inferior responses for all of the shared serotypes in patients aged 70 years or older who had been previously vaccinated at least 5 years prior with PPSV23. Significantly higher immune responsiveness was found for a majority of the serotypes in the older age groups (i.e., 50–59 years old, 60–64 years old, ≥ 70 years old).25

The Community–Acquired Pneumonia Immunization Trial in Adults (CAPITA) was a randomized, double–blind, placebo–controlled trial of 84,496 persons in the Netherlands that evaluated the efficacy of PCV13. The study conclusively demonstrated a PCV13 efficacy of 45.6% for first episodes of infections due to the 13 serotypes included in the vaccine (49 infections in the PCV13 group; 90 infections in the placebo group). Prevention of nonbacteremic and noninvasive CAP was similar, with PCV13 achieving an efficacy of 45% (33 infections in the PCV13 group; 60 persons in the placebo group). Efficacy against IPD was 75% (7 infections in the PCV13 group; 28 infections in the placebo group).26 The large number of participants in this study imparts a high degree of confidence in the reproducibility of the results for the prevention of infection by the serotypes included in the vaccine.

The CDC completed another analysis of a nationwide inpatient sample database that confirmed that the introduction of PCV7 to the U.S. childhood immunization schedule had a somewhat unexpected positive effect of lowering the rate of pneumococcal disease in older adults. In fact, data show that older adults accounted for more than half the decline in overall hospitalizations for pneumonia during the study period. This study was the first to document a significant "herd effect" of conjugate polysaccharide vaccines. Still, the authors noted that significant clinical infections due to vaccine–included serotypes still occur in adults and that enhanced vaccination activities among adults will likely be necessary to see further reductions in adult infections due to pneumococcus.9

Pneumococcal conjugate vaccine safety

The safety of PCV13 has been evaluated in several studies reported by the manufacturer and confirmed by the CAPITA trial. The most common local adverse events in adult patients include injection site pain, redness, swelling, and limitation of arm movement. Systemically, the most common events reported after PCV13 administration are muscle or joint pain, fatigue, headache, chills, rash, and decreased appetite; in patients aged 18 to 49 years old, vomiting has also been noted.25,26

ACIP RECOMMENDATIONS FOR PNEUMOCOCCAL VACCINATION

The ACIP has revised the recommendations for use of pneumococcal vaccines in adult patients, with the last major revision occurring in 2014. Table 3 was created by the National Foundation for Infectious Diseases and clearly summarizes the current recommendations.27 For these recommendations, cerebrospinal fluid leaks and cochlear implants are considered high–risk conditions for IPD, and asplenia is considered to increase the risks of both IPD and noninvasive pneumococcal disease. Pharmacists should pay particular attention to the increased risk of pneumococcal disease in persons who are utilizing immunosuppressive drug therapies, which may include high–dose corticosteroids, drugs used for solid organ transplant immunosuppression, and biologic agents such as tumor necrosis factor–alpha inhibitors and interleukin inhibitors.

Table 3. Adult Pneumococcal Vaccination Guide25
Provided by the National Foundation for Infectious Diseases.
http://www.adultvaccination.org/professional-resources/pneumo/adult-pneumo-guide-hcp.pdf

As listed in Table 3, certain patients, including anyone aged 65 years or older, are candidates for both PCV13 and PPSV23.27 The CDC specifically recommends both vaccines because of the results of the CAPITA trial related to pneumococcal pneumonia. The 2 vaccines share 12 serotypes; another 11 serotypes are unique to PPSV23 and 1 is unique to PCV13. According to data from 2013, the additional protection against 11 serotypes provided by PPSV23 has an efficacy of approximately 38% for preventing IPD cases in adults aged 65 years or older.19

The sequence of administration of the 2 vaccines is an important consideration and is included as part of the ACIP recommendations. Ideally, for persons aged 65 years or older who are immunocompetent, PCV13 should be administered first, followed 1 year later by a single dose of PPSV23. If a patient received a dose of PPSV23 on or after his or her 65th birthday, then it is important to wait 1 full year prior to administering a single dose of PCV13. The manufacturer of PCV13 has reported data that show that antibody titers may be diminished if PCV13 is given at an interval shorter than 1 year following PPSV23, although there is currently no evidence to show the clinical impact of a reduced interval.25 There is no need for revaccination or additional doses of either vaccine in immunocompetent individuals aged 65 years or older, as additional doses have not been shown to improve clinical efficacy.19,22

For individuals who are at least 19 years of age and who are immunocompromised (note the list of immunocompromising conditions included in Table 3),27 a single dose of PCV13 should be administered first, followed by a dose of PPSV23 at least 8 weeks later. A revaccination dose of PPSV23 should be administered 5 years or more after the initial PPSV23 dose. Individuals receiving this sequence who are younger than 65 years old should then receive a single dose of PPSV23 after the age of 65 years and at least 5 years after any PPSV23 dose that was administered before 65 years of age.

If a person who is in the highest–risk category for immunization has already received 1 or more doses of PPSV23 at the time of an immunization assessment, he or she should receive a single dose of PCV13 at least 1 year after any previous dose(s) of PPSV23. In this scenario, the patient would only require 1 subsequent dose of PPSV23 if he had not already received 2 doses of PPSV23: the second dose of PPSV23 should occur at least 5 years after the first dose.23

Currently, PCV13 is not readministered to adult patients. It is only recommended as a single dose for adult patients regardless of underlying conditions or age. Thus, for the immunocompromised adult patient, the maximum number of doses of PCV13 is 1, while the maximum number of doses of PPSV23 is 3 (at least 1 of which should occur after the age of 65 years).28 For patients with cerebrospinal fluid leaks, sickle cell disease or other hemaglobinopathies, asplenia, or cochlear implants, clinicians should follow the same immunization recommendations as for patients who are immunocompromised.23

Finally, immunocompetent adult patients aged 18 to 64 years who have select chronic conditions (Table 3) or who are cigarette smokers should receive a single dose of PPSV23.27 There is currently no recommendation for routine administration of additional doses of PPSV23 in this population until on or after the 65th birthday, and there is currently no routine recommendation for the use of PCV13 in this population.28

CMS REQUIREMENTS AND VACCINE PAYMENT FOR LTC FACILITIES

In 2015, CMS changed its coverage for pneumococcal vaccines to more closely reflect the recommendations of the ACIP. Medicare Part B will now provide reimbursement for both PPSV23 and PCV13; however, a single vaccine must be administered and billed initially, and then a different vaccine can be administered and billed 1 year later. Medicare covers pneumococcal, influenza, and hepatitis B vaccines under the Medicare Part B benefit over and above an LTC facility's bundled payment for provider services. In addition, contracted providers for immunizations (e.g., pharmacies/pharmacists) can bill CMS using their own provider identification numbers and do not have to bill through the facility.29

Billing Medicare Part B for pneumococcal vaccines requires a pharmacist to utilize codes for billing that are different from the National Drug Code–based billing with which pharmacists are most familiar. Pharmacists must first provide a diagnosis code for the preventive vaccine: when pneumococcal vaccine and the influenza vaccine are not administered on the same day, code V03.82 should be used; when both the influenza vaccine and the pneumococcal vaccine are administered on the same day, the correct code is V06.6. After selecting the appropriate diagnosis code, the pharmacist should then select the appropriate Current Procedural Terminology (CPT) code. For PCV13, CPT code 90670 should be used, and, for PPSV23, code 90732. Finally, the administration fee for either pneumococcal vaccine should be billed using code G0009.30 Pharmacists should consult with their Medicare Part B carriers for specifics regarding billing methodology (e.g., electronic systems).

CMS is increasingly concerned about quality in the provision of health care services for which the agency provides payment. On October 1, 2017, a new Long–Term Care Facility Resident Assessment User's Manual 3.0 went into effect for skilled nursing facilities and nursing homes.31 The new manual contains specific reference to the ACIP recommendations for receipt of pneumococcal vaccines, and LTC facilities' recommendations, administrations, and billing processes for these vaccines will be measured by CMS. Further, CMS supports and advocates for the use of pneumococcal vaccine standing orders within LTC facilities. Pharmacists should be familiar with all CMS standards, including those related to pneumococcal vaccines.

Implementing vaccination programs in LTC settings

The CDC strongly recommends that hospitals, LTC facilities, pharmacies, and other health care settings implement standing orders for ACIP–recommended vaccines, including pneumococcal vaccines. Because vaccines hold the federal "Rx Only" designation, pharmacists must have a prescription for the vaccines to be administered, except where otherwise provided by state law. Standing orders eliminate the need for individual patient prescriptions by serving as the legal order from a prescriber articulating the circumstances by which a non–prescribing provider can select and administer vaccines. The Immunization Action Coalition (IAC) has created templates for standing orders for several vaccines, including pneumococcal vaccine. An example standing order from IAC is provided in Figure 1.32 For standing order templates for pneumococcal and other vaccines, visit http://www.immunize.org/standing–orders/. Additionally, pharmacists should consult with state laws regarding requirements for documentation of or inclusion in standing orders.

Figure 1.  Standing Order Template for Administering Pneumococcal Vaccines to Adults33
Reprinted with permission from the Immunization Action Coalition.
http://www.immunize.org/catg.d/p3075.pdf

Almost without exception, residents of LTC facilities should be offered pneumococcal vaccines. Best practices indicate that such an offer should occur at the time of admission to the facility, and that, prior to immunizing the patient, a reasonable effort should be made to determine the patient's pneumococcal immunization status. Pneumococcal immunization status can be determined in the following ways:

  • Patient recall of previous immunization. The CDC affirms that a patient's or caregiver's recollection of having received pneumococcal vaccine is an acceptable validation of immunization status. Notably, providers should determine which of the 2 available vaccines the patient has previously received (PCV13 or PPSV23).
  • Primary care or pharmacy record review. If a patient does not recall being previously vaccinated, LTC providers should assess pre–admission primary care and pharmacy records to determine if pneumococcal vaccine has been administered.
  • Immunization information systems (IIS). All 50 states now have IIS, which are registries that were originally created to provide continuity of documentation of pediatric immunization events. Most ISSs are capable of recording immunizations through adulthood and, indeed, across a patient's lifespan. LTC facilities and providers are strongly encouraged to document immunizations administered within the facility with the respective state's IIS. Documenting within an IIS serves several useful purposes:
    • Minimizes duplicate or unnecessary doses of vaccine
    • Facilitates communication among all health care providers caring for the patient
    • Serves as a legal record of doses administered in compliance with the federal no–fault Vaccine Injury Compensation Program, a federal program that relieves providers and manufacturers of certain liability risks
    • Allows for documentation of vaccine refusal so that other providers can advocate for vaccination at future health care encounters

For more information about IIS, including contact information for each state's IIS administrator, visit the CDC's website: https://www.cdc.gov/vaccines/programs/iis/contacts– locate–records.html.33

If a patient in an LTC facility is unable to provide consent to be immunized, it is appropriate to make an offer to immunize to the caregiver. Caregivers should be provided with information regarding the benefits and risks of the patient receiving the pneumococcal vaccine, and a current vaccine information statement (VIS) should be provided. VISs for both PCV13 and PPSV23 are provided in Figures 2 and 3 and are available online in multiple languages at https://www.cdc.gov/vaccines/hcp/vis/current–vis.html.34,35

Figure 2. Vaccine Information Statement: Pneumococcal Conjugate Vaccine35
Reprinted with permission from the Centers for Disease Control and Prevention.
https://www.cdc.gov/vaccines/hcp/vis/vis-statements/pcv13.pdf

Figure 3. Vaccine Information Statement: Pneumococcal Polysaccharide Vaccine36
Reprinted with permission from the Centers for Disease Control and Prevention.
https://www.cdc.gov/vaccines/hcp/vis/vis-statements/ppv.pdf

SUMMARY

Pneumococcal disease is a serious illness, particularly in those aged 65 years or older, in individuals with chronic underlying conditions, and in those with immunocompromising conditions. The nationwide incidence of hospitalization associated with pneumococcal pneumonia among LTC facility residents is not well defined, but anecdotal data from case reports indicate that the rate of hospitalization is likely higher in this population than in younger, healthier people. Understandably, hospitalization rates, as well as mortality rates, for infectious diseases increase with advancing age. Therefore, the CDC recommends age–based vaccination for all immunocompetent adults aged 65 years or older with a single dose of PCV13, followed 1 year later by a single dose of PPSV23. No additional doses of either vaccine are necessary for this age–based indication.

For those with immunocompromising conditions and select additional high–risk conditions (e.g., asplenia, cochlear implants, cerebrospinal fluid leaks), a single dose of PCV13 should be followed at least 8 weeks later with a dose of PPSV23. A repeat dose of PPSV23 should be administered 5 years later in this population. No additional doses of PCV13 are recommended, and 1 final additional dose of PPSV23 is recommended for patients aged 65 years or older if the previous doses occurred prior to the age of 65 years for this population.

Pharmacists working in or consulting with LTC facilities have a crucial role to play in identifying and immunizing patients against pneumococcal disease. As the drug therapy experts of the health care team, pharmacists should include vaccines as part of every drug regimen review or drug utilization review. Standing orders should be implemented within LTC facilities to minimize barriers and maximize opportunities for vaccination by the first available care provider, whether that is a nurse, medical technician, pharmacist, physician, or other health care professional. Both FDA–licensed pneumococcal vaccines (PCV13 and PPSV23) are covered by Medicare Part B and can be billed to the agency's carrier over and above the LTC facility's bundled billing for all other services. This means that either the facility or a contracted provider, such as a pharmacy or pharmacist, can be remunerated for pneumococcal vaccines administered to facility residents. LTC facility pneumococcal vaccination needs are great, and pharmacists are well positioned to improve access and outcomes through provision of this service.

REFERENCES

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  2. U.S. Department of Health and Human Services; Centers for Disease Control and Prevention; National Center for Health Statistics. Long-term Care Providers and Service Users in the United States: Data from the National Study of Long-term Care Providers, 2013-2014. https://www.cdc.gov/nchs/data/series/sr_03/sr03_038.pdf. Published February 2016. Accessed October 24, 2017.
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  19. Tomczyk S, Bennett NM, Stoecker C, et al; Centers for Disease Control and Prevention. Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among adults aged ³65 years: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morbid Mortal Wkly Rep. 2014;63(37):822-825.
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  23. Centers for Disease Control and Prevention. Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine for adults with immunocompromising conditions: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2012;61(40):816-819.
  24. Goldblatt D, Southern J, Andrews N, et al. The immunogenicity of 7-valent pneumococcal conjugate vaccine versus 23-valent polysaccharide vaccine in adults aged 50-80 years. Clin Infect Dis. 2009;49(9):1318-1325.
  25. Prevnar 13 [package insert]. Philadelphia, PA: Pfizer Inc.;2017.
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  28. Centers for Disease Control and Prevention; Advisory Committee on Immunization Practices. Updated recommendations for prevention of invasive pneumococcal disease among adults using the 23-valent pneumococcal polysaccharide vaccine (PPSV23). MMWR Morb Mortal Wkly Rep. 2010;59(34);1102-1106.
  29. Department of Health and Human Services; Centers for Medicare & Medicaid Services. Modifications to Medicare Part B coverage of pneumococcal vaccines. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM9051.pdf. Published December 31, 2014. Accessed October 24, 2017.
  30. American Academy of Family Physicians. Vaccine coverage for Medicare Part B. http://www.aafp.org/practice-management/payment/coding/admin/partb.html. Accessed October 24, 2017. 
  31. Centers for Medicare & Medicaid Services. Long-term Care Facility Resident Assessment Instrument 3.0 User's Manual: version 1.15. https://downloads.cms.gov/files/MDS-30-RAI-Manual-v115-October-2017.pdf. Published October 2017. Accessed October 24, 2017.
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  35. Centers for Disease Control and Prevention. Pneumococcal polysaccharide VIS. https://www.cdc.gov/vaccines/hcp/vis/vis-statements/ppv.html. Updated October 18, 2016. Accessed October 24, 2017.

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