25460 Federal Register / Vol. 76, No. 86 / Wednesday, May 4, 2011 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 482, 485, 491, and 494 

[CMS–3213–P] 

RIN 0938–AP92 

Medicare & Medicaid Programs; 

Influenza Vaccination Standard for 

Certain Participating Providers and 

Suppliers 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

require certain Medicare and Medicaid 

providers and suppliers to offer all 

patients an annual influenza 

vaccination, unless medically 

contraindicated or unless the patient or 

patient’s representative or surrogate 

declined vaccination. This proposed 

rule is intended to increase the number 

of patients receiving annual vaccination 

against seasonal influenza and to 

decrease the morbidity and mortality 

rates from influenza. This proposed rule 

would also require certain providers 

and suppliers to develop policies and 

procedures that would allow them to 

offer vaccinations for pandemic 

influenza, in case of a future pandemic 

influenza event for which a vaccine may 

be developed. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. EST on July 5, 2011. 

ADDRESSES: In commenting, please refer 

to file code CMS–3213–P. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the instructions under the ‘‘More Search 

Options’’ tab. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–3213–P, P.O. Box 8010, Baltimore, 

MD 21244–1850. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3213–P, Mail 

Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments before the close 

of the comment period to either of the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue, SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786– 

9994 in advance to schedule your 

arrival with one of our staff members. 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

Submission of comments on 

paperwork requirements. You may 

submit comments on this document’s 

paperwork requirements by following 

the instructions at the end of the 

‘‘Collection of Information 

Requirements’’ section in this document. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Lauren Oviatt, (410) 786–4683. Maria 

Hammel, (410) 786–1775. Jeannie 

Miller, (410) 786–3164. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 

8:30 a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

A. General Overview 

Various sections of the Social Security 

Act (the Act) define the terms that 

Medicare uses for each provider and 

supplier’s regulatory provisions. In 

some cases, these definitions describe 

the requirements providers and 

suppliers must meet for purposes of the 

Medicare program. Generally, these 

provisions also specify that the 

Secretary of the Department of Health 

and Human Services (HHS) (the 

Secretary) may establish such other 

requirements as the Secretary finds 

necessary in the interest of the health 

and safety of individuals receiving 

services. 

The Secretary has established in 

regulations the requirements that each 

provider and supplier must meet to 

participate in the Medicare and 

Medicaid programs. These requirements 

are called the Conditions of 

Participation (CoPs) for providers and 

the Conditions for Coverage or 

Conditions for Certification (CfCs) for 

certain suppliers. The CoPs and CfCs are 

intended to protect public health and 

safety and to ensure that high quality 

care is provided to all persons. 

To help reduce the spread of seasonal 

influenza infection, we are proposing to 

establish influenza vaccination 

standards for the following providers 

and suppliers: 

• Hospitals (all types that participate 

in Medicare) 

• Critical Access Hospitals (CAHs) 

• Rural Health Clinics (RHCs) 

• Federally Qualified Health Centers 

(FQHCs) 

• End-Stage Renal Disease (ESRD) 

Facilities 

These providers and suppliers have in 

common two key factors: (1) In each 

setting, the patients present before 

health care providers with staff licensed 

to provide vaccination at the time and 

location of the encounter; and (2) all 

have ready access to equipment and 


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storage appropriate for handling, 

controlling, and administering vaccines. 

B. The Impact of Influenza 

Influenza and pneumococcal disease 

kill more people in the United States 

(U.S.) each year than all other vaccinepreventable diseases combined. 

Influenza and pneumonia combined 

represent the fifth leading cause of 

death in the elderly. Influenza infection 

rates are highest among children, yet 

rates of serious illness and death are 

highest among persons age 65 or older 

and persons of any age who have 

medical conditions that place them at 

increased risk for complications from 

influenza (See Centers for Disease 

Control (CDC), ‘‘Prevention and Control 

of Influenza: Recommendations of the 

Advisory Committee on Immunization 

Practices (ACIP)’’, MMWR 2008; 57(RR– 

7): 1–60). 

The estimated number of annual 

influenza-associated deaths from 

respiratory and circulatory causes 

(including pneumonia and influenza 

causes) during 1976 through 2007, 

ranged from 3,349 in 1986 through 1987 

to 48,614 in 2003 through 2004. An 

average of 220,000 influenza-associated 

hospitalizations occurred during 

seasonal influenza epidemics over the 

same time period. Ninety percent of the 

influenza related deaths occur in the 65 

years and older age group. When 

combined with underlying medical 

conditions, this group’s estimated risk 

of influenza-associated hospitalizations 

is 560 per 100,000 persons, compared 

with 190 per 100,000 healthy elderly 

persons. Among persons age 50 to 64, 

the risk for influenza-associated 

hospitalizations is also substantially 

higher for persons with underlying 

conditions compared with healthy 

adults. (See CDC, ‘‘Estimates of Death 

Associated With Seasonal Influenza— 

United States, 1976–2007,’’ MMWR 

2010; 59(33):1057–1062; and CDC, 

‘‘Prevention and Control of Seasonal 

Influenza with Vaccines: 

Recommendations of the Advisory 

Committee on Immunization Practices 

(ACIP)’’, MMWR 2009; 58(RR–8): 1–56). 

The economic cost to society for 

seasonal influenza has been estimated to 

be $87.1 billion each year, including 

$10.4 billion in direct medical costs 

(See Molinari NA, Ortega-Sanchez JR, 

Messonnier ML, et al., ‘‘The annual 

impact of seasonal influenza in the US: 

Measuring disease burden and costs,’’ 

Vaccine 2007; 25: 5086–96). 

C. Influenza Prevention Through 

Vaccination 

Influenza vaccination is the primary 

method for preventing influenza and its 

more severe complications. According 

to the ACIP, influenza vaccination 

should be provided to all persons 6 

months of age and older (CDC, 

‘‘Prevention and Control of Influenza 

with Vaccines: Recommendations of the 

Advisory Committee on Immunization 

Practices (ACIP)’’, MMWR 2010; 59 (RR– 

8): 1–62). While certain groups are at 

higher risk for influenza infection or 

complications (including infants 

younger than 6 months and children 

from ages 6 months to 18 years old, 

pregnant women, persons age 50 or 

older, and adults with certain chronic 

medical conditions), vaccination can 

offer protection to all individuals. 

However, less than 40 percent of the 

population received an influenza 

vaccination during the 2008 to 2009 

influenza season. (See CDC, ‘‘Prevention 

and Control of Seasonal Influenza with 

Vaccines: Recommendations of the 

Advisory Committee on Immunization 

Practices (ACIP)’’, MMWR 2009; 58(RR– 

8): 1–56). 

Vaccination has been shown to reduce 

influenza illness, work absenteeism, 

antibiotic use, physician visits, 

hospitalization, and deaths. An ACIP 

report states that, ‘‘vaccination is 

associated with reductions in influenzarelated respiratory illness and physician 

visits among all age groups, 

hospitalization and death among 

persons at high risk, otitis media (ear 

infections) among children, and work 

absenteeism among adults’’ (See 

MMWR, ‘‘Recommendations and 

Reports’’, May 28, 2004/53(RR06); 1–40). 

Although influenza vaccination levels 

increased substantially during the 

1990s, further improvements in vaccine 

coverage levels are needed. The Healthy 

People 2010 target for influenza 

vaccination among persons age 65 or 

older was 90 percent and the Healthy 

People 2020 target for this population 

continues at 90 percent (IID 12.7 at 

http://www.healthypeople.gov/2020/ 

topicsobjectives2020/ 

objectiveslist.aspx?topicid=23). The 

national influenza vaccination coverage 

for the 2006 to 2007 influenza season 

among persons age 65 or older was 

estimated to be only 66.8 percent 

(National Health Interview Survey, 

2007, http://www.cdc.gov/nchs/data/ 

nhis/earlyrelease/200806_04.pdf). 

We believe that there are missed 

opportunities for vaccinating persons, 

especially those at higher risk for 

influenza complications, including 

opportunities to vaccinate patients who 

are in the hospital for other causes. In 

a national study of Medicare patients 

(who are primarily elderly or disabled) 

hospitalized with common clinical 

conditions, a large proportion had not 

received influenza vaccination before 

hospitalization and very few received 

vaccination while in the hospital (See 

Bratzler DW, Houck PM, Jiang H, et al., 

‘‘Failure to vaccinate Medicare 

inpatients: A missed opportunity’’, Arch 

Intern Med 2002; 162: 2349–56). 

Although the success of childhood 

vaccination programs has resulted in the 

reduction or elimination of vaccinepreventable diseases among children, 

similar success has not been attained 

among adults (See Roush SW, Murphy 

TV, ‘‘Historical Comparisons of 

Morbidity and Mortality for VaccinePreventable Diseases in the U.S.’’, JAMA 

2007; 298(18): 2155–2163). 

We have made previous efforts to 

increase vaccination. For example, 

Section 4107 of the Balanced Budget 

Act of 1997 extended the influenza and 

pneumococcal vaccination campaign 

conducted by the Centers for Medicare 

& Medicaid Services (CMS) in 

conjunction with CDC and the National 

Coalition for Adult Immunization 

(NCAI) through fiscal year 2002, 

authorizing $8 million for each fiscal 

year from 1998 to 2002. Although 

Medicare coverage of influenza vaccine 

was increased under this legislation, 

rates of vaccination did not improve as 

anticipated. 

On October 2, 2002, we published a 

final rule with comment period entitled, 

‘‘Condition of Participation: 

Immunization Standards for Hospitals, 

Long-Term Care Facilities, and Home 

Health Agencies’’ (67 FR 61808) that 

removed the patient-specific physician 

order requirement for the administration 

of influenza and pneumococcal vaccines 

from the CoPs for Medicare and 

Medicaid participating hospitals, LTC 

facilities, and home health agencies 

(HHAs). The final rule was effective as 

of its October 2, 2002 publication date. 

These vaccines can now be 

administered per a physician approved 

facility or agency policy, following 

assessment of the patient or resident for 

contraindications. On October 7, 2005, 

we published a final rule entitled, 

‘‘Condition of Participation: 

Immunization Standard for Long Term 

Care Facilities’’ (70 FR 58834) that 

requires participating nursing homes to 

offer all residents an annual influenza 

vaccination. This final rule was a major 

step towards increasing the vaccination 

rates in the LTC population, as the 

vaccination rate reached 90 percent in 

the first year the rule was effective 

(beginning October 7, 2005, per the 

Current Medicare Beneficiary Survey). 

More recent data from the Minimum 

Data Set shows that the national average 

for influenza vaccinations administered 

to LTC residents is approximately 91 


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percent (data period October 1, 2008 

through March 31, 2010). 

Other strategies for increasing rates of 

influenza vaccination include physician 

reminders (for example, flagging charts) 

and patient reminders (CDC, MMWR 

2008; 57(RR–7): 1–60). In February 

2010, the ACIP expanded its previous 

vaccination recommendations to 

include all adults beginning in the 2010 

through 2011 influenza season. That is, 

the ACIP now recommends that all 

people age 6 months and older receive 

annual influenza vaccinations (CDC, 

‘‘Prevention and Control of Influenza 

with Vaccines: Recommendations of the 

Advisory Committee on Immunization 

Practices (ACIP)’’, MMWR 2010; 59 (RR– 

8): 1–62). 

Until this year, ACIP 

recommendations endorsed by the CDC 

(hereafter referred to as ACIP 

recommendations) for seasonal 

influenza vaccination focused on 

vaccination of higher risk adults, 

children ages 6 months to 18 years, and 

persons with close contact with people 

of higher risk. These recommendations 

applied to about 85 percent of the U.S. 

population. However, the ACIP is now 

focusing its attention on protecting all 

people, including healthy persons aged 

6 months and older, who were hard hit 

by the 2009 H1N1 pandemic virus, 

which has continued circulating into 

this season and may continue beyond. 

Previously the ACIP did not specifically 

recommend vaccination for healthy 

adults between the ages of 19 and 49. 

Another reason cited in favor of a 

universal recommendation for 

vaccination is that many people in 

currently recommended ‘‘higher risk’’ 

groups are unaware that they are 

considered at risk and recommended for 

vaccination. The ACIP also recognizes 

the practicality and value of issuing a 

simple and clear message regarding the 

importance of influenza vaccination in 

the hopes that this would remove 

impediments to vaccination and expand 

coverage. 

Finally, new data collected over the 

course of the 2009 H1N1 pandemic 

indicates that some people who did not 

previously have a specific 

recommendation for vaccination may 

also be at higher risk of serious 

influenza-related complications, 

including those people who are obese, 

post-partum women, and people in 

certain racial/ethnic groups (http:// 

www.cdc.gov/media/pressrel/2010/ 

r100224.htm and CDC, ‘‘Prevention and 

Control of Influenza with Vaccines: 

Recommendations of the Advisory 

Committee on Immunization Practices 

(ACIP)’’, MMWR 2010; 59 (RR–8): 1–62). 

D. Pandemic Influenza 

A pandemic is the worldwide spread 

of a new disease. An influenza 

pandemic occurs when a new influenza 

virus emerges and spreads around the 

world, and most people do not have 

immunity. Viruses that have caused past 

pandemics typically originated from 

animal influenza viruses. 

This dynamic nature of influenza 

viruses creates the possibility that a new 

virus will develop, either through 

mutation or mixing of individual 

influenza viruses, in turn creating the 

possibility for new viral strains that can 

cause illness and spread efficiently 

among humans. When a pandemic virus 

strain emerges, 25 to 35 percent of the 

population could develop clinical 

disease, increasing their risk of 

mortality. The direct and indirect health 

costs alone (not including disruptions in 

trade and other costs to business and 

industry) have been estimated to 

approach $181 billion for a moderate 

pandemic (similar to those in 1957 and 

1968) with no interventions. Faced with 

the threat of a severe pandemic, the U.S. 

and its international partners will need 

to respond quickly and forcefully to 

reduce the spread of influenza and 

lessen the number of severe illnesses 

and deaths and the burden on the 

healthcare system. HHS has developed 

the HHS Pandemic Influenza Plan 

specifically to prepare for responding to 

a severe pandemic (see http:// 

www.hhs.gov/pandemicflu/plan/ 

part1.html). 

In April 2009, a new influenza A 

(H1N1) virus was determined to be the 

cause of influenza illness in two 

children in the United States during 

March and April 2009 and the cause of 

outbreaks of respiratory illness in 

Mexico. This virus was transmitted in 

communities across North America 

within weeks and was identified in 

many areas of the world by May 2009. 

On June 11, 2009, the World Health 

Organization (WHO) declared a 

worldwide pandemic, indicating 

ongoing community-level transmission 

of the novel influenza A (H1N1) virus in 

multiple areas of the world. As with the 

seasonal influenza, vaccination is the 

most effective method for preventing 

pandemic influenza and related 

complications. (CDC, MMWR 2009; 

58(RR10); 1–8). However, substantial 

amounts of infection occurred before 

adequate amounts of vaccine were 

available. While the full impact of the 

H1N1 pandemic has yet to be assessed, 

there is a need for health care providers 

and suppliers to be prepared to offer any 

available vaccines for pandemic 

influenza events when vaccine becomes 

available to ensure that delays in 

vaccine administration are minimized. 

Please see Section III of this preamble 

for a discussion of vaccine supply. 

II. Disparities 

In 1985, the Secretary of HHS issued 

a landmark report (colloquially known 

as the Heckler Report, for former HHS 

Secretary Margaret Heckler) which 

revealed large and persistent gaps in 

health status among different racial and 

ethnic groups and served as an impetus 

for addressing health inequalities for 

racial and ethnic minorities in the U.S. 

This report led to the establishment of 

the Office of Minority Health (OMH) 

within HHS, with a mission to address 

these disparities within the U.S. 

National concerns for these differences, 

termed health disparities, and the 

associated excess mortality and 

morbidity have been the focus of 

national health status reviews, 

including Healthy People 2000, 2010, 

and 2020. 

Since the release of the Heckler 

Report, research has extensively 

documented the pervasiveness of health 

and health care disparities. Currently, 

vulnerable populations can be defined 

by race or ethnicity, socio-economic 

status, geography, gender, age, disability 

status, risk status related to sex and 

gender, and other populations identified 

to be at-risk for health disparities. We 

are aware that other populations at risk 

may include persons with visual, 

hearing, cognitive perceptual problems, 

language barriers, pregnant women, 

infants, and persons with disabilities or 

special health care needs. 

Much attention has been given to 

reducing health disparities in 

vulnerable populations at the national 

level. We remain vigilant in our efforts 

to improve health care quality for all 

persons by improving health care access 

and by eliminating real and perceived 

barriers to care that may contribute to 

less than optimal health outcomes for 

all populations. We are aware that 

vaccination rates remain low among 

some minority populations. As stated 

above, the national influenza 

vaccination coverage for the 2006 

through 2007 influenza season among 

persons age 65 and older has been 

estimated to be 66.8 percent; the rate is 

higher for non-Hispanic whites (69.3 

percent) compared to non-Hispanic 

blacks (56.4 percent) and Hispanics 

(53.1 percent) (National Health 

Interview Survey, 2007, http:// 

www.cdc.gov/nchs/data/nhis/ 

earlyrelease/200806_04.pdf). Key 

reasons for these disparities include 

differences in vaccine-seeking by 

patients and differences in the 


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likelihood of providers recommending 

vaccination (Herbert PL, Frick KD, Kane 

RL, McBean AM, ‘‘The causes of racial 

and ethnic differences in influenza 

vaccination rates among elderly 

Medicare beneficiaries’’, Health Serv Res 

2005; 40: 517–37; Winston CA, Wortley 

PM, Lees KA, ‘‘Factors associated with 

vaccination of Medicare beneficiaries in 

five U.S. communities: Results from the 

Racial and Ethnic Adult Disparities in 

Immunization Initiative survey’’, 2003. 

J Am Geriatr Soc 2006; 54: 303–10). 

We believe that expanding access to 

influenza vaccination through the 

provisions proposed in this rule would 

address the needs of vulnerable 

populations and help to diminish health 

and health care disparities. We believe 

our proposed inclusion of FQHCs 

among provider types covered by this 

proposed rule should greatly assist in 

this goal. For example, 71 percent of 

FQHC patients live in poverty and 38 

percent are uninsured (http:// 

www.hrsa.gov/data-statistics/healthcenter-data/index.html). FQHCs include 

several different types of health centers, 

including centers that focus on 

particularly disadvantaged groups such 

as migrants, homeless, public housing 

residents, and native Hawaiians. 

Therefore, we are specifically requesting 

comments in regard to how we could 

strengthen our proposed requirements 

to address disparities. 

III. Adequacy of Vaccine Supply 

We recognize that there have been 

years where the release of vaccine was 

delayed or less than expected. For 

example, in the fall of 2004 there was 

a major shortage of inactivated influenza 

vaccine in the U.S. One of the major 

manufacturers of the influenza vaccine 

informed CDC in early October 2004, 

that none of its influenza vaccine would 

be available for distribution in the U.S. 

Because of the shortage, Federal health 

officials released interim guidelines as 

to who should receive an influenza 

vaccination, describing those at highrisk of influenza-related health 

complications as a priority group. At 

that time, the interim recommendations 

from CDC stated that people age 65 and 

older, as well as persons between the 

ages of 2 to 64 with chronic medical 

conditions and children ages 6 to 23 

months, were to be prioritized for 

receiving influenza vaccination. Other 

groups deemed a priority were nursing 

home residents. 

We understand that providers and 

suppliers may be concerned about how 

they would meet the requirements of 

this proposed rule in the event of an 

influenza vaccine shortage. We would 

not be able to require providers and 

suppliers to offer vaccination if they 

were unable to obtain vaccine supplies. 

We would expect providers and 

suppliers to make timely efforts to 

acquire vaccines. In the case of limited 

supply, we would expect providers and 

suppliers to follow any guidance issued 

by CDC regarding priority groups for 

vaccination. 

IV. Provisions of the Proposed 

Regulations 

We are proposing to require certain 

providers and suppliers to develop and 

implement policies and procedures 

regarding annual influenza and 

pandemic influenza vaccination. 

Pandemic procedures would be 

implemented when a pandemic event 

was announced by the Secretary. The 

proposed policies and procedures 

would be required to take into account, 

and reflect reasonable consideration of, 

guidelines established by nationally 

recognized organizations (for example, 

CDC and the American Academy of 

Pediatrics), including, but not limited 

to, guidelines addressing patients for 

whom vaccination may be prioritized or 

temporarily contraindicated. 

The proposed influenza vaccination 

standard would (to the extent 

applicable) affect the following 

Medicare- and Medicaid-participating 

providers and suppliers: Hospitals (all 

types, including Short-term Acute Care, 

Psychiatric, Rehabilitation, Long Term 

Care, Children’s, and Cancer), Critical 

Access Hospitals (CAHs), Rural Health 

Clinics (RHCs), Federally Qualified 

Health Centers (FQHCs), and End-Stage 

Renal Disease (ESRD) Facilities. We 

have proposed this standard for these 

provider and supplier types because we 

believe that each of them have—(a) RNs 

or other appropriately licensed medical 

personnel present when serving 

patients; and (b) the ability to manage 

vaccination and vaccine supplies with 

minimal additional cost or 

complications (for example, they 

already store and manage medications). 

Due to the benefits that these 

provisions are estimated to offer 

(discussed later in this rule), we plan, 

after consideration of any comments 

received, to publish the proposed 

regulations as final in the early Fall of 

2011, with the intent that they would 

become effective during the 2011 

through 2012 influenza season. We 

believe that the potential consequences 

of not finalizing this rule as soon as 

possible far outweigh the burden that 

would be imposed on providers and 

suppliers. We welcome your comments 

on these publication and 

implementation plans. 

Below, we set forth the influenza 

vaccination requirements that we 

propose each of the above providers and 

suppliers meet. 

1. Hospitals—Conditions of 

Participation: Infection Control 

(§ 482.42) 

The following provisions of this 

proposed rule would apply to all 

hospitals in the Medicare and Medicaid 

programs. Section 1861(e)(1) through 

(e)(9) of the Act—(1) Defines the term 

‘‘hospital’’; (2) lists some of the statutory 

requirements that a hospital must meet 

to be eligible for Medicare participation; 

and (3) specifies that a hospital must 

also meet other requirements as the 

Secretary finds necessary in the interest 

of the health and safety of the hospital’s 

patients. Under this authority, the 

Secretary has established in the 

regulations 42 CFR part 482, the 

requirements that a hospital must meet 

to participate in the Medicare program. 

Section 1905(a) of the Act provides that 

Medicaid payments may be applied to 

hospital services. Regulations at 42 CFR 

§ 440.10(a)(3)(iii) require hospitals to 

meet the Medicare CoPs to qualify for 

participation in Medicaid. 

We are proposing to add a new CoP 

standard for influenza vaccination at 

§ 482.42(c). The proposed standard 

would require all types of hospitals 

regulated under the hospital CoPs to 

establish policies and procedures for 

administering annual influenza 

vaccinations, and pandemic influenza 

vaccinations in the case of a pandemic 

event. Pandemic procedures would be 

implemented when a pandemic event 

was announced by the Secretary. The 

hospital’s policies and procedures 

would have to take into account, and 

reflect reasonable consideration of, the 

recommendations in guidelines 

established by nationally recognized 

organizations (including, but not limited 

to, guidelines addressing patients for 

whom vaccination may be prioritized or 

temporarily contraindicated). The 

proposed policies and procedures 

would be required to ensure that the 

patient was offered the influenza 

vaccination as soon as the vaccine was 

available, on or after September 1 

through the end of February, except 

when medically contraindicated, when 

the patient or the patient’s 

representative or surrogate declined 

vaccination, or if the patient had already 

received that year’s vaccination. 

This standard would also require 

hospitals to educate the patient or 

patient’s representative or surrogate on 

the benefits and risks associated with 

the vaccination. The patient’s 

representative or surrogate, who could 


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be a family member or friend that 

accompanied the patient, could act as a 

liaison between the patient and the 

hospital to help the patient 

communicate, understand, remember, 

and cope with the interactions that took 

place during the visit, and explain any 

instructions to the patient that were 

delivered by the hospital staff. If a 

patient was unable to fully 

communicate directly with hospital 

staff, then the hospital could give 

vaccination information to the patient’s 

representative or surrogate. The patient 

also would have the choice of using an 

interpreter of his or her own or one 

supplied by the hospital. A professional 

interpreter is not considered to be a 

patient’s representative or surrogate. 

Rather, it is the professional 

interpreter’s role to pass information 

from the hospital to the patient. In 

addition, this standard would require 

the hospital to update the patient’s 

health records to include (at a 

minimum) the date the patient or 

patient’s representative or surrogate 

received education on influenza 

vaccination, and the date of 

administration or refusal of the vaccine. 

Hospitals often have large outpatient 

populations, including those who may 

attend clinics (such as physical therapy 

clinics) that are not necessarily prepared 

to provide vaccine injections. This 

proposed rule would require that all 

hospital patients be offered vaccination. 

Therefore, we would expect that the 

hospital’s policies and procedures 

address all patients, whether they were 

receiving inpatient or outpatient 

services. For example, it could be 

appropriate to refer certain outpatients 

to another clinic or department on the 

hospital campus if the patient wanted to 

receive vaccination and the outpatient 

was in a department of the hospital that 

was not equipped to administer the 

vaccine. 

As stated above, influenza vaccination 

would be offered throughout the 

influenza season to all persons 6 months 

of age and older for whom vaccination 

is not contraindicated. Vaccination is 

expected to offer both direct protection 

to the patients receiving vaccination and 

indirect benefits to others by decreased 

exposure to infected persons. 

2. Critical Access Hospitals—Condition 

of Participation: Provision of Services 

(§ 485.635) 

Section 1820(c)(2)(B) of the Act sets 

out criteria for designation as a CAH, 

and section 1820(e)(3) of the Act 

instructs the Secretary to certify a 

facility as a CAH if the facility, among 

other things, ‘‘meets such other criteria 

as the Secretary may require.’’ Under 

this authority, the Secretary has 

established CoPs for CAHs at 42 CFR 

part 485, subpart F. Our CoP at 

§ 485.635 sets out our requirements 

regarding provision of services at CAHs. 

We are proposing to add a new CoP 

standard for influenza vaccination at 

§ 485.635(b). The proposed standard 

would require Critical Access Hospitals 

(CAHs) to establish policies and 

procedures for administering annual 

influenza vaccination, and pandemic 

influenza vaccination in the case of a 

pandemic event. Pandemic procedures 

would be implemented when a 

pandemic event was announced by the 

Secretary. The CAH’s policies and 

procedures would have to take into 

account, and reflect reasonable 

consideration of, the recommendations 

in guidelines established by nationally 

recognized organizations (including, but 

not limited to, guidelines addressing 

patients for whom vaccination may be 

prioritized or temporarily 

contraindicated). The proposed policies 

and procedures would ensure that the 

patient was offered the influenza 

vaccination as soon as the vaccine was 

available, on or after September 1 

through the end of February, except 

when medically contraindicated, when 

the patient or the patient’s 

representative or surrogate declined 

vaccination, or when the patient already 

received that year’s vaccine. This 

standard would also require CAHs to 

educate the patient or patient’s 

representative or surrogate on the 

benefits and risks associated with the 

vaccine. The patient’s representative or 

surrogate, who could be a family 

member or friend that accompanied the 

patient, could act as a liaison between 

the patient and the CAH to help the 

patient communicate, understand, 

remember, and cope with the 

interactions that would take place 

during the visit, and explain any 

instructions to the patient that were 

delivered by the CAH staff. If a patient 

was unable to fully communicate 

directly with CAH staff, then the CAH 

could give vaccination information to 

the patient’s representative or surrogate. 

The patient also would have the choice 

of using an interpreter of his or her own 

or one supplied by the CAH. A 

professional interpreter is not 

considered to be a patient’s 

representative or surrogate. Rather, it is 

the professional interpreter’s role to 

pass information from the CAH to the 

patient. In addition, this standard would 

require the CAH to update the patient’s 

health records to include (at a 

minimum) the date the patient or 

patient’s representative or surrogate 

received education on the influenza 

vaccination, and the date of 

administration or refusal of the vaccine. 

As stated above, the influenza vaccine 

would be offered throughout the 

influenza season to all persons over the 

age of 6 months for whom vaccination 

was not contraindicated. Requiring 

CAHs to offer influenza vaccination 

would offer both direct protection to the 

patients receiving vaccination and 

indirect benefits to others through 

decreased exposure to infected persons. 

3. Rural Health Clinics and FQHCs— 

Provision of Services (§ 491.9) 

We are proposing to add a new CfC 

standard for influenza vaccination at 

§ 491.9(d). The proposed standard 

would require Rural Health Clinics 

(RHCs) and Federally Qualified Health 

Centers (FQHCs) to establish policies 

and procedures for administering 

annual influenza vaccinations and 

pandemic influenza vaccinations, in the 

case of a pandemic event. Pandemic 

procedures would be implemented 

when a pandemic event was announced 

by the Secretary. The clinic or center’s 

policies and procedures would have to 

take into account, and reflect reasonable 

consideration of, the recommendations 

in guidelines established by nationally 

recognized organizations (including, but 

not limited to, guidelines addressing 

patients for whom vaccination may be 

prioritized or temporarily 

contraindicated). The proposed policies 

and procedures would ensure that the 

patient was offered the influenza 

vaccination, except when medically 

contraindicated, when the patient or the 

patient’s representative or surrogate 

declined vaccination, or when the 

patient already received that year’s 

vaccine. 

This standard would also require 

RHCs and FQHCs to educate the patient 

or patient’s representative or surrogate 

on the benefits and risks associated with 

the vaccine. The patient’s representative 

or surrogate, who could be a family 

member or friend that accompanied the 

patient, could act as a liaison between 

the patient and the RHC or FQHC to 

help the patient communicate, 

understand, remember, and cope with 

the interactions that might take place 

during the visit, and explain any 

instructions to the patient that would be 

delivered by the RHC or FQHC staff. If 

a patient was unable to fully 

communicate directly with RHC or 

FQHC staff, then the RHC or FQHC 

could give vaccination information to 

the patient’s representative or surrogate. 

The patient would also have the choice 

of using an interpreter of his or her own 

or one supplied by the RHC or FQHC. 


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A professional interpreter is not 

considered to be a patient’s 

representative or surrogate. Rather, it is 

the professional interpreter’s role to 

pass information from the RHC or FQHC 

to the patient. In addition, this standard 

would require the RHC or FQHC to 

update the patient’s health records to 

include (at a minimum) the date the 

patient or patient’s representative or 

surrogate received education on the 

influenza vaccination, and the date of 

administration or refusal of the vaccine. 

As stated above, influenza vaccine 

would be offered throughout the 

influenza season to all persons over the 

age of 6 months for whom vaccination 

was not contraindicated. Requiring 

RHCs and FQHCs to offer influenza 

vaccination would offer both direct 

protection to the patients receiving 

vaccination and indirect benefits to 

others through decreased exposure to 

infected persons. 

4. ESRD Facility—Condition for 

Coverage: Infection Control (§ 494.30) 

We are proposing to add a new CfC 

standard for influenza vaccination at 

§ 494.30(d). The proposed standard 

would require ESRD facilities to 

establish policies and procedures for 

administering annual influenza 

vaccinations, and pandemic influenza 

vaccinations in the case of a pandemic 

event. Pandemic procedures would be 

implemented when a pandemic event 

was announced by the Secretary. The 

ESRD facility’s policies and procedures 

would have to take into account, and 

reflect reasonable consideration of, the 

recommendations in guidelines 

established by nationally recognized 

organizations (including, but not limited 

to, guidelines addressing patients for 

whom vaccination might be prioritized 

or temporarily contraindicated). The 

proposed policies and procedures 

would ensure that each patient was 

offered the influenza vaccination, 

except when medically contraindicated, 

when the patient or the patient’s 

representative or surrogate declined 

vaccination, or when the patient had 

already received that year’s vaccine. 

This standard would also require 

ESRD facilities to educate the patient or 

patient’s representative or surrogate on 

the benefits and risks associated with 

the vaccine. The patient’s representative 

or surrogate, who could be a family 

member or friend that accompanies the 

patient, may act as a liaison between the 

patient and the ESRD facility to help the 

patient communicate, understand, 

remember, and cope with the 

interactions that take place during the 

visit, and explain any instructions to the 

patient that are delivered by the ESRD 

facility staff. If a patient is unable to 

fully communicate directly with the 

ESRD facility, then the ESRD facility 

may give vaccination information to the 

patient’s representative or surrogate. 

The patient also has the choice of using 

an interpreter of his or her own or one 

supplied by the ESRD facility. A 

professional interpreter is not 

considered to be a patient’s 

representative or surrogate. Rather, it is 

the professional interpreter’s role to 

pass information from the ESRD facility 

to the patient. In addition, it would 

require the ESRD facility to update the 

patient’s health records to include (at a 

minimum) the date the patient or 

patient’s representative or surrogate 

received education on the influenza 

vaccination, and the date of 

administration or refusal of the vaccine. 

As stated above, the influenza vaccine 

should be offered throughout the 

influenza season to all persons over the 

age of 6 months for whom vaccination 

is not contraindicated. Requiring ESRD 

facilities to offer influenza vaccination 

would offer both direct protection to the 

patients receiving vaccination and 

indirect benefits to others through 

decreased exposure to infected persons. 

V. Collection of Information 

Requirements 

Under the Paperwork Reduction Act 

of 1995, we are required to provide 60- 

day notice in the Federal Register and 

solicit public comment before a 

collection of information requirement is 

submitted to the Office of Management 

and Budget (OMB) for review and 

approval. In order to fairly evaluate 

whether an information collection 

should be approved by OMB, section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 requires that we 

solicit comment on the following issues: 

• The need for the information 

collection and its usefulness in carrying 

out the proper functions of our agency. 

• The accuracy of our estimate of the 

information collection burden. 

• The quality, utility, and clarity of 

the information to be collected. 

• Recommendations to minimize the 

information collection burden on the 

affected public, including automated 

collection techniques. 

We believe that many of the providers 

and suppliers addressed in this 

proposed rule already offer annual 

influenza vaccinations, and offered the 

H1N1 vaccine in 2009–2010, but for the 

purposes of this analysis, we are 

assuming that all of the providers and 

suppliers would need to develop new 

policies and procedures. We are 

soliciting public comment on the 

information collection requirements 

(ICRs) discussed below: 

A. ICRs Regarding Condition of 

Participation: Infection Control 

(§ 482.42) 

Proposed § 482.42(c)(1) would require 

a hospital to develop and implement 

policies and procedures regarding 

seasonal influenza and pandemic 

influenza vaccination. Proposed 

§ 482.42(c)(2) would further specify that 

policies and procedures must take into 

account, and reflect reasonable 

consideration of, guidelines established 

by nationally recognized organizations. 

The hospital would also be required to 

comply with the conditions listed at 

proposed § 482.42(c)(3), which includes, 

but is not limited to, patient (or patient 

representative or surrogate) education 

with respect to the benefits, risks, and 

potential side effects of the vaccination. 

The burden associated with the 

requirements in this section would be 

the time and effort necessary to develop 

and implement policies and procedures 

regarding annual influenza and 

pandemic influenza vaccinations. Since 

the policies would address annual 

vaccinations, there would also be an 

ongoing burden associated with 

maintaining the policies and 

procedures. Similarly, there would also 

be some burden associated with 

performing the patient (or patient 

representative or surrogate) education as 

stated at proposed § 482.42(c)(3). We 

estimate that 5,100 hospitals would be 

required to comply with these 

requirements. We also estimate that it 

would take 5 hours to develop, 

implement and annually maintain the 

policies and procedures for influenza 

vaccination. The estimated annual 

burden associated with developing, 

implementing and maintaining policies 

and procedures is 25,500 hours (5,100 

hospitals × 5 hours per hospital). The 

total estimated annual cost associated 

with these requirements is $1,147,500 

(25,500 hours × $45 per hour). 

We further estimate that it would take 

each of the 5,100 hospitals 3 minutes to 

perform the patient or patient 

representative or surrogate education a 

total of 20,000,000 times annually. The 

estimated annual burden associated 

with this requirement is 1,000,000 hours 

(20,000,000 responses × .05 hours per 

response). The total estimated annual 

cost associated with these requirements 

is $45,000,000 (1,000,000 hours × $45 

per hour). 


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B. ICRs Regarding Condition of 

Participation: Provision of Services 

(§ 485.635) 

Proposed § 485.635 states that CAHs 

must develop and implement policies 

and procedures regarding seasonal 

influenza and pandemic influenza 

vaccination. Proposed § 485.635(b)(2) 

further specifies that policies and 

procedures must take into account, and 

reflect reasonable consideration of, 

guidelines established by nationally 

recognized organizations. The CAH 

would also be required to comply with 

the conditions listed at proposed 

§ 485.635(b)(3), which include but are 

not limited to patient (or patient 

representative or surrogate) education 

with respect to the benefits, risks, and 

potential side effects of the vaccination. 

The burden associated with the 

requirements in this section would be 

the time and effort necessary to develop 

and implement policies and procedures 

regarding annual influenza and 

pandemic influenza vaccination. Since 

the policies would address annual 

vaccinations, there would also be an 

ongoing burden associated with 

maintaining the policies and 

procedures. Similarly, there would also 

be some burden associated with 

performing the patient (or patient 

representative or surrogate) education as 

stated at proposed § 485.635(b)(3). We 

estimate that 1,300 CAHs would be 

required to comply with these proposed 

requirements. We also estimate that it 

would take 5 hours to develop, 

implement, and annually maintain the 

policies and procedures for influenza 

vaccination. The estimated annual 

burden associated with developing, 

implementing and maintaining policies 

and procedures is 6,500 hours (1,300 

CAHs × 5 hours per CAH). The total 

estimated annual cost associated with 

these requirements is $292,500 (6,500 

hours × $45 per hour). 

We further estimate that it would take 

each of the 1,300 CAHs 3 minutes to 

perform the patient or patient 

representative or surrogate education. 

We have included the number of hours 

and costs for these services in the 

overall hospital total in the preceding 

discussion of burden for § 482.4. 

C. ICRs Regarding Provision of Services 

(§ 491.9) 

Proposed § 491.9 states that RHCs and 

FQHCs would have to develop and 

implement policies and procedures 

regarding seasonal influenza and 

pandemic influenza vaccination. 

Proposed § 491.9(d)(2) further specifies 

that policies and procedures would 

have to take into account, and reflect 

reasonable consideration of, guidelines 

established by nationally recognized 

organizations. The RHC or FQHC would 

also have to comply with the conditions 

listed at proposed § 491.9(d)(3), which 

would include but not be limited to 

patient (or patient representative or 

surrogate) education with respect to the 

benefits, risks, and potential side effects 

of the vaccination. 

The burden associated with the 

requirements in this section would be 

the time and effort necessary to develop 

and implement policies and procedures 

regarding seasonal influenza and 

pandemic influenza vaccination. Since 

the policies would address annual 

vaccination, there would also be some 

ongoing burden associated with 

maintaining the policies and 

procedures. Similarly, there would also 

be a burden associated with performing 

the patient (or patient representative or 

surrogate) education as stated at 

proposed § 491.9(d)(3). 

We estimate that 3,800 RHCs and 

1,100 FQHCs would be required to 

comply with these requirements. We 

also estimate that it would take 5 hours 

to develop, implement and annually 

maintain the policies and procedures for 

influenza vaccination. The estimated 

annual burden associated with this 

requirement is 24,500 hours (4,900 

facilities × 5 hours per facility). The 

total estimated annual cost associated 

with these proposed requirements is 

$1,102,500 (24,500 hours × $45 per 

hour). 

We further estimate that it would take 

each of the 4,900 RHCs or FQHCs 3 

minutes to perform the patient or 

patient representative or surrogate 

education 25,000,000 times annually. 

The estimated annual burden associated 

with this requirement is 1,250,000 hours 

(25,000,000 responses × .05 hours per 

response). The total estimated annual 

cost associated with these proposed 

requirements is $56,250,000 (1,250,000 

hours × $45 per hour). 

D. ICRs Regarding Condition: Infection 

Control (§ 494.30) 

Proposed § 494.30 states that ESRD 

facilities would have to develop and 

implement policies and procedures 

regarding seasonal influenza and 

pandemic influenza vaccination. 

Proposed § 494.30(d)(2) further specifies 

that policies and procedures would 

have to take into account, and reflect 

reasonable consideration of, guidelines 

established by nationally recognized 

organizations. The ESRD facility would 

also be required to comply with the 

conditions listed at proposed 

§ 494.30(d)(3), which would include, 

but not be limited to, patient (or patient 

representative or surrogate) education 

with respect to the benefits, risks, and 

potential side effects of the vaccination. 

The burden associated with the 

requirements in this section would be 

the time and effort necessary to develop 

and implement policies and procedures 

regarding seasonal influenza and 

pandemic influenza vaccination. Since 

the policies would address annual 

vaccinations, there would also be an 

ongoing burden associated with 

maintaining the policies and 

procedures. Similarly, there would also 

be some burden associated with 

performing the patient (or patient 

representative or surrogate) education, 

as stated at proposed § 494.30(d)(3). We 

estimate that 5,400 ESRD facilities 

would be required to comply with these 

requirements. We also estimate that it 

would take 5 hours to develop, 

implement and annually maintain the 

policies and procedures for influenza 

vaccination. The estimated annual 

burden associated with this requirement 

is 27,000 hours (5,400 facilities × 5 

hours per facility). The total estimated 

annual cost associated with these 

proposed requirements is $1,215,000 

(27,000 hours × $45 per hour). 

We further estimate that it would take 

each of the 5,400 ESRD facilities 3 

minutes to perform the patient or 

patient representative or surrogate 

education 500,000 times annually, for a 

total estimated burden of 25,000 hours 

(500,000 responses × .05 hours per 

response). The estimated annual cost is 

$1,125,000 (25,000 hours × $45 per 

hour). 

The total estimated annual cost 

associated with these proposed 

requirements is approximately $106 

million, as shown in Table 1. 


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TABLE 1—ESTIMATED ANNUAL RECORDKEEPING AND REPORTING REQUIREMENTS

Regulation 

section(s) 

OMB Control 

No. Respondents Responses 

Burden 

per 

response 

(hours) 

Total annual 

burden 

(hours) 

Hourly labor 

cost of 

reporting ($) 

Total labor 

cost of 

reporting ($) 

Total capital/ 

maintenance 

costs ($) 

Total cost 

($) 

§ 482.4(c) ..... 0938—New .. 5,100 5,100 5 25,500 ** 45 1,147,500 0 1,147,500 

5,100 20,000,000 .05 1,000,000 ** 45 45,000,000 0 45,000,000 

§ 485.635(b) 0938—New .. 1,300 1,300 5 6,500 ** 45 292,500 0 292,500 

§ 491.1 ......... 0938—New .. 4,900 4,900 5 24,500 ** 45 1,102,500 0 1,102,500 

4,900 25,000,000 .05 1,250,000 ** 45 56,250,000 0 56,250,000 

§ 494.30 ....... 0938—New .. 5,400 5,400 5 27,000 ** 45 1,215,000 0 1,215,000 

5,400 500,000 .05 25,000 45 1,125,000 0 1,125,000 

Total ..... ...................... 16,700 45,516,700 .................... 2,358,500 ........................ ........................ ........................ 106,132,500 

* $31.31 is the mean hourly wage of a registered nurse according to the Bureau of Labor Statistics of the U.S. Department of Labor (http://www.bls.gov/oes/current/ 

oes291111.htm#nat). We have increased this rate to include the fringe benefits and overhead costs of these staff, for a total of $45 an hour, rounded. Fringe benefits 

equal about 30% of total compensation, according to the BLS (http://www.bls.gov/news.release/ecec.nr0.htm). We assume that nurses will be the professional staff 

primarily involved in establishing policies and procedures, performing patient education, and administering vaccines, and that other staff involved will have hourly 

wages both higher and lower than nurses, but on average a similar amount. 

** Totals for these functions may differ slightly from those in RIA analysis due to rounding. Note that the RIA contains several categories of costs, such as vaccines 

and vaccine administration, that are not PRA costs. 

If you comment on these information 

collection and recordkeeping 

requirements, submit your comments 

electronically as specified in the 

ADDRESSES section of this proposed rule. 

VI. Regulatory Impact Analysis 

A. Introduction 

We have examined the impacts of this 

rulemaking as required by Executive 

Orders 12866 (September 1993) and 

13563 (January 2011). Executive Orders 

12866 and 13563 direct agencies to 

assess all costs and benefits of available 

regulatory alternatives and, if regulation 

is necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). Executive Order 13563 

emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. A 

regulatory impact analysis (RIA) must 

be prepared for rules with economically 

significant effects ($100 million or more 

in any 1 year). This proposed rule has 

been designated an ‘‘economically 

significant’’ regulatory action under 

section 3(f)(1) of Executive Order 12866. 

Accordingly, the rule has been reviewed 

by the Office of Management and 

Budget. 

B. Statement of Need 

We have determined that these 

proposed CoPs and CfCs would protect 

public health and safety and ensure 

high quality care to patients in the 

settings that would be subject to this 

requirement. Increasing the utilization 

of effective preventive services is a goal 

of both CMS and CDC. We believe that 

this proposed rule would facilitate the 

delivery of appropriate vaccinations in 

a timely manner, increase vaccination 

coverage levels, and decrease morbidity 

and mortality rates associated with 

seasonal influenza. We believe that the 

‘‘required request’’ approach we are 

proposing would encourage patients to 

receive desired vaccinations without 

expending both time and trouble to find 

out where to obtain them, and allow 

them to obtain expert and 

individualized advice. Patients could 

receive vaccinations without making an 

extra trip to a medical care provider or 

inconveniently waiting to receive 

service. As a result, we expect the costs 

of the proposal would be far lower per 

patient served than alternatives, the 

resulting rates of vaccination and 

protection from influenza far higher, the 

economic and life-saving benefits 

substantial, and the net effects 

overwhelmingly beneficial. 

C. Overall Impact 

We estimate in the analysis that 

follows that the costs associated with 

this proposed rule would be 

approximately $330 million annually 

and that its quantifiable, monetized 

benefits would be approximately $830 

million annually, reflecting decreased 

medical care costs ($710 million) and 

savings in patient time ($120 million). 

In addition, the proposed rule would 

have substantial life-saving effects that 

we have not quantified. The distribution 

of medical costs and savings by payer is 

summarized in the table below: 

TABLE 2—DISTRIBUTION OF MEDICAL COSTS AND SAVINGS

[$ In millions] 

Primary payer 

Gross 

vaccination 

cost 

Reduced 

treatment 

costs 

to payers 

Net cost to 

payers 

Medicare ...................................................................................................................................... $165 ¥$545 ¥$380 

Medicaid ....................................................................................................................................... 35 ¥35 0 

Private Insurance ......................................................................................................................... 130 ¥130 0 

Total ...................................................................................................................................... 330 ¥710 ¥380 

As described in more detail below, we 

estimate that all categories of payers 

would at least break even in financial 

terms. There is substantial uncertainty 

over both the cost and benefit estimates, 

and we believe that either estimate 

could be as much as 50 percent higher 

or lower. 

D. Anticipated Costs 

In order to comply with this rule, 

providers and suppliers would need to 

develop the necessary policies and 


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procedures to be followed by staff as 

standard practices. In Table 3, we 

estimate that the number and types of 

providers potentially subject to the 

proposed rule would be as follows: 

TABLE 3—ESTIMATED NUMBER OF PROVIDERS & SUPPLIERS AFFECTED BY THE INFLUENZA VACCINATION PROPOSED

RULE* 

Provider/supplier Number 

Hospitals (incl. Psychiatric and Inpatient Rehabilitation Facilities) ..................................................................................................... 5,100 

Critical Access Hospitals (CAHs) ........................................................................................................................................................ 1,300 

Rural Health Clinics (RHCs) ................................................................................................................................................................ 3,800 

Federally Qualified Health Centers (FQHCs) ...................................................................................................................................... 1,100 

End-Stage Renal Disease Facilities (ESRD Facilities) ....................................................................................................................... 5,400 

Total Providers and Suppliers ...................................................................................................................................................... 16,700 

In Table 4, we present our estimate of 

the likely annual time and costs that 

providers and suppliers would need to 

spend each year in policy development 

and planning activities. Because each 

influenza season is unique, and because 

there are periodic updates to vaccine 

recommendations and advice, as well as 

local variations in disease incidence 

each year, we estimate that these costs 

would continue to be incurred each 

year. 

TABLE 4—ESTIMATED ANNUAL POLICY AND PROCEDURE IMPLEMENTATION COSTS RELATED TO THE INFLUENZA

VACCINATION PROPOSED RULE

Number of Providers/Suppliers ............................................................................................................................................................ 16,700 

Hours spent per Provider/Supplier ...................................................................................................................................................... 5 

Total hours ........................................................................................................................................................................................... 83,500 

Cost per hour ** ................................................................................................................................................................................... $45 

Total cost to providers and suppliers (millions) ........................................................................................................................... $3.75 

* Source is CMS data on participating Medicare providers. 

** See Table 1 for basis of hourly cost estimate. 

This rule proposes that the patient’s 

vaccination status be documented in the 

patient’s medical record. The status 

must indicate, at a minimum, the 

following: that the patient (or the 

patient’s representative or surrogate) 

was asked whether the patient was 

already vaccinated; that patients not 

already vaccinated were provided 

education regarding the benefits, risks, 

and potential side effects of influenza 

vaccination; and that these patients 

either received the influenza 

vaccination or did not receive the 

influenza vaccination due to medical 

contraindications, previous influenza 

vaccination during the current influenza 

season, or patient refusal. We estimate 

that documentation would take 

approximately 0.6 minutes per patient, 

one percent of an hour, taking into 

account all situations (for example, 

whether the patient had already 

received the vaccine, or newly received 

the vaccine). 

Tables 5 and 6 summarize the likely 

effects of this proposed requirement, 

based on patient volume at each type of 

facility. 

TABLE 5—ESTIMATED NUMBER OF PATIENTS BY TYPE OF PROVIDER & SUPPLIER

Provider/supplier Number 

Hospitals (incl. Psychiatric and Inpatient Rehabilitation Facilities) * ..................................................................................................... 20,000,000. 

Critical Access Hospitals (CAHs) * ........................................................................................................................................................ Incl. above. 

Rural Health Clinics (RHCs) ................................................................................................................................................................. 5,000,000. 

Federally Qualified Health Centers (FQHCs) ....................................................................................................................................... 20,000,000. 

End-Stage Renal Disease Facilities (ESRD Facilities) ......................................................................................................................... 500,000. 

Total Patients ................................................................................................................................................................................. 45,500,000. 

* Hospital and CAH data assume one half of annual discharges; all others use annual caseload of unique patients. 

TABLE 6—ESTIMATED ANNUAL MEDICAL RECORD COSTS RELATED TO THE INFLUENZA VACCINATION PROPOSED RULE

Number of patients (millions) ............................................................................................................................................................... 45.5 

Hours spent per patient ....................................................................................................................................................................... .01 

Total hours (millions) ........................................................................................................................................................................... .45 

Cost per hour* ..................................................................................................................................................................................... $45 

Total cost to providers and suppliers (millions) .................................................................................................................... $20.2M 

* See Table 1 for basis of hourly cost estimate. 


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In addition, facility staff would need 

to ask the questions above (that is, 

ascertain vaccination status, and explain 

the risks and benefits to patients who 

have not previously been vaccinated). 

We estimate that this process would 

take an average of 3 minutes, or 0.05 of 

an hour, as shown in Table 7. 

TABLE 7—ESTIMATED ANNUAL PATIENT INQUIRY AND COUNSELING COSTS RELATED TO THE INFLUENZA VACCINATION

PROPOSED RULE* 

Number of patients (millions) ............................................................................................................................................................... 45.5 

Hours spent per patient ....................................................................................................................................................................... .05 

Total hours (millions) ........................................................................................................................................................................... 2.3 

Cost per hour ** ................................................................................................................................................................................... $45 

Total cost to providers and suppliers (millions) .................................................................................................................... $103M 

* Most data from preceding tables. 

** See Table 1 for basis of hourly wage estimate. 

For those patients who agree to 

receive vaccination, time would be 

required to obtain and position supplies 

and equipment, to perform the 

vaccination, and to dispose of sharps. 

We estimate that, on average, this would 

take an additional 6 minutes per patient, 

or 0.1 of an hour. For purposes of this 

analysis, we assume that twenty percent 

of all patients have been vaccinated 

before the provider request is made. The 

basis for this estimate is that since 

overall about 40 percent of Americans 

currently are vaccinated over the course 

of the influenza season (http:// 

www.cdc.gov/mmwr/preview/ 

mmwrhtml/ 

rr5908a1.htm?s_cid=rr5908a1_e), about 

half of these persons would have been 

vaccinated before one of the provider 

encounters covered by this proposed 

rule. We estimate that one half of the 

remainder (40 percent) would agree to 

be vaccinated, for a total vaccination 

rate among these persons of 60 percent 

(see sensitivity discussion later in this 

analysis). We also estimate that the 

elderly would be disproportionately 

likely to take the vaccine, since the risks 

they face, which would have been 

explained to them, are so much higher 

than the general patient population. We 

have found no empirical basis for any 

estimate in the literature, but believe 

that a specific request to patients 

already being served by the facilities 

covered by this proposed rule is likely 

to substantially increase the proportion 

of the population agreeing to what, 

under this rule, would be a far more 

convenient health care offering. We 

welcome comments on this assumption. 

Finally, we also assume that one half 

of the additional 40 percent would have 

been vaccinated elsewhere, later in the 

influenza season, so that only half of 

this amount represents additional 

vaccination costs to society. In other 

words, absent these proposed 

requirements, 40 percent of these 

persons would have been vaccinated 

somewhere else, but these encounters 

lead half of that 40 percent to be 

vaccinated by the providers affected by 

this proposed rule rather than 

elsewhere. 

Accordingly, assuming that the 

patient population at these facilities on 

average reasonably approximates the 

vaccination status of the population at 

large, the total percentage of these 

patients we estimate will ultimately be 

vaccinated will rise to 60 percent from 

40 percent (20 percent already 

vaccinated plus 40 percent newly 

vaccinated equals 60 percent total 

vaccination rate), but the net increase in 

those vaccinated is only half of the 

number vaccinated at these facilities (20 

percent already vaccinated plus 40 

percent newly vaccinated less the 20 

percent who would later have been 

vaccinated equals the same 60 percent 

total vaccination rate). Using these same 

fractions, the net cost of vaccine 

administration for these patients is not 

the amount we estimate in the ‘‘total 

cost’’ line of Table 7 will be spent at 

these facilities, but that amount less 

spending on the 20 percent who would 

later have been vaccinated elsewhere, 

for a ‘‘net cost to society’’ line in Table 

8 that is only half as large. We 

emphasize that these are rough 

estimates intended to show the general 

magnitudes of the effects of the 

proposed rule. Therefore, although we 

estimate these providers would 

vaccinate half of those not already 

vaccinated, the total percentage of the 

patient population in these settings we 

estimate will be vaccinated is 60 

percent, not 80 percent. 

TABLE 8—ESTIMATED ANNUAL VACCINATION ADMINISTRATION COSTS RELATED TO THE INFLUENZA VACCINATION

PROPOSED RULE

Number of patients vaccinated under this rule (millions) * .................................................................................................................. 18.2 

Hours spent per patient ....................................................................................................................................................................... .1 

Total hours (millions) ........................................................................................................................................................................... 1.8 

Cost per hour ** ................................................................................................................................................................................... $45 

Total cost to providers and suppliers (millions) ................................................................................................................................... $81M 

Less reduction in costs to other providers (millions) ........................................................................................................................... ¥$40.5M 

Net cost to society (millions) ............................................................................................................................................................... $40.5M 

* Forty percent of total patients. 

** See Table 1 for basis of hourly cost estimate. 

In addition, these patients would 

receive the vaccine itself. The cost of the 

vaccine is not well established in the 

literature, in part because the existence 

of substantial government intervention 

in the market, and special prices for 

public purchasers, complicate the 

matter. Medicare itself pays about $12 

per dose, and for purposes of this 

analysis we assume that about half of 

the patients who would otherwise not 

be vaccinated are Medicare or Medicaid 

beneficiaries, that the price to Medicare 

or Medicaid is therefore applicable to 

half of all patients who would be 

vaccinated under this proposed rule. In 

this regard, about 40 percent of all 

hospital admissions are for the elderly 


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and almost half of all FQHC patients are 

Medicare (7 percent) or Medicaid (37 

percent) participating (See 2009 Data 

Snapshot for health center data at 

http://www.hrsa.gov/data-statistics/ 

health-center-data/NationalData/2009/ 

2009datasnapshot.html). Medicare and 

Medicaid between them finance the 

great majority of care for the elderly, 

who are most at risk to influenza 

infection and related complications, 

most likely to be served by providers 

subject to the proposed rule, and, 

therefore we estimate, most likely to 

agree to be vaccinated. We further 

assume that the price for private-pay 

patients is twice as high, for an average 

of $18 across all publicly and privately 

financed patients. Based on these 

assumptions, and previous tables, Table 

9 shows the cost of vaccine under the 

proposed rule. 

TABLE 9—ESTIMATED ANNUAL VACCINE COSTS RELATED TO THE INFLUENZA VACCINATION PROPOSED RULE

Number of patients vaccinated under this rule (millions) * .................................................................................................................. 18.2M 

Average vaccine cost per patient ........................................................................................................................................................ $18 

Total cost billed through these providers and suppliers (millions) ...................................................................................................... $327M 

Less reduction in cost billed through other providers and suppliers ** (millions) ............................................................................... ¥$163.5M 

Net cost to society (millions) ............................................................................................................................................................... $163.5M 

* Forty percent of total patients. 

** Twenty percent would have been vaccinated by other providers. 

Unlike the previous tables, which 

estimated initial costs to providers and 

supplier subject to this proposed rule, 

we assume that none of the costs of 

vaccine will be paid by those entities. 

Instead, in the vast majority of cases the 

cost of the vaccine will be paid by 

public or private insurers, and in most 

of the remainder by the patients 

themselves. In total, we estimate (tables 

4, 6, 7, and 8) that providers and 

suppliers covered by this proposed rule 

would incur total annual costs of about 

$170 million ($3.75M, $20.2M, $103M, 

and $40.5M respectively). Almost all of 

this would be reimbursed by insurance 

or charges to patients, so the net cost to 

providers would be far less. The total 

cost per provider and supplier, 

however, would average only about 

$5,000 even if they bore all of the cost. 

Since hospitals and FQHCs each 

account for almost half of all patients 

affected by this proposed rule, they 

would incur the great majority of these 

costs. Other provider and supplier types 

would incur far lower costs, because 

they have far fewer patients on average. 

Another way to look at these costs is 

on a per-patient basis. Taking into 

account all costs including vaccines, 

whether incurred by providers, patients, 

or third-party insurance (including 

Medicare and Medicaid), the costs of the 

proposed rule are about $330 million 

annually for those who would not 

otherwise have been vaccinated. Based 

on the estimates above, the gross total 

cost of vaccination is about $30 per 

person, and the net cost $18 per person. 

This latter figure actually overestimates 

the net cost, since it assumes that the 

cost in other settings is identical, which 

it is not (see the discussion which 

follows). Vaccination incidental to a 

medical encounter for another purpose 

(for example, dialysis or surgical 

procedure) saves substantial costs in 

patient and provider time compared to 

a standalone visit. 

We have not incorporated one major 

cost reduction in the preceding tables. 

Because we estimate that half of the 18 

million patients vaccinated under this 

rule would have been vaccinated in 

other settings at a later time, those 

patients would avoid the sometimes 

substantial costs of time and 

inconvenience they would otherwise 

have incurred. On average, a separate 

trip to a medical care provider to be 

vaccinated is likely to consume close to 

an hour. For example, a trip to a drug 

store might involve a 20 minute drive, 

a 20 minute wait in line, and a 20 

minute drive home. A trip to a 

physician office might take even longer. 

Assuming that patient time is valued at 

$20 an hour, and that the 9 million 

patients estimated as likely to have been 

vaccinated elsewhere had they not been 

vaccinated in one of the settings 

proposed in this rule, the potential time 

savings are on the order of 9 million 

hours, valued potentially at $180 

million. (Note: $20 an hour is a very 

rough estimate taking into account that 

in most cases patients use leisure time 

rather than otherwise paid time for nonemergency visits; this value has been 

used in other Federal analyses of 

consumer time.) Some of these patients 

would have found ways to combine 

these visits with other trips to the same 

settings, but even if one third of them 

had done so, time savings would still be 

perhaps 6 million hours and $120 

million. (There are also provider 

savings, but these are estimated in the 

preceding tables.) The time savings to 

these patients are a substantial 

additional benefit of this rule, reducing 

time spent by most from roughly one 

hour plus a few minutes for actual 

vaccine administration to just the few 

minutes for vaccine administration. 

It is possible that an increase in the 

number of influenza vaccinations 

provided may result in a slight increase 

in the number of adverse events. 

Persons who experience an adverse 

event as a result of an influenza 

vaccination may be eligible for 

compensation under the National 

Vaccine Injury Compensation Program. 

E. Anticipated Benefits 

For purposes of a point estimate of 

benefits, we estimate above that the 

overall vaccination rate, by the end of 

the influenza season, would rise from 

about 40 percent to about 60 percent as 

the net result of this rule, if issued in 

final as proposed, for approximately 45 

million covered patients. That 

corresponds to a net additional 9 

million persons vaccinated. These 

persons would on average be younger 

than those protected under the rule 

issued in 2005 to protect the 

disproportionately elderly patients in 

long term care facilities, but would on 

average be far older than the population 

at large simply by virtue of Medicare or 

Medicaid coverage and disproportionate 

use by the elderly of providers 

addressed under this proposed rule. 

This estimate of effectiveness is heavily 

influenced by the results of the recent 

initiative to increase vaccination rates 

among nursing home residents. It 

appears that person-to-person 

counseling by health care professionals, 

especially to elderly patients already 

under care, with vaccination 

conveniently available after patient 

assent, is vastly more effective in 

obtaining patient participation than 

generalized public awareness campaigns 

or simple availability of insurance 

coverage. For example, a person willing 

to be vaccinated after a public 

awareness campaign would still have to 

identify a participating provider, travel 

to the vaccination location, arrive at a 


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time when the service is offered, and 

wait for service (in many settings 

patients wait in long lines). The patients 

addressed by this proposed rule avoid 

such inconvenience and cost. 

The benefits of influenza vaccination 

in preventing morbidity and mortality 

are highest among the elderly, so the 

benefits of this proposed rule would not 

be as high, per person, as under the 

2005 rule, which addressed the 

overwhelmingly elderly population of 

nursing homes. We nonetheless estimate 

the benefits of this proposed rule as very 

substantial, many times higher than the 

cost of the rule. Rates of influenza 

infection, seriousness of illness, vaccine 

effectiveness, and mortality prevention 

all vary by age of patient and by health 

status of patient. For example, a recent 

study estimates the average annual rate 

of influenza-associated deaths with 

underlying respiratory and circulatory 

causes to be .2 per 100,000 persons in 

the population from infancy through age 

18, 1.5 per 100,000 persons from age 19 

through age 64, and 66.1 per 100,000 

persons at age 65 or above (M.G. 

Thompson, et al, ‘‘Estimates of Deaths 

Associated with Seasonal Influenza— 

United States, 1976–2007,’’ CDC, 

MMWR 10, 59(33): 1057–1062). 

We do not have detailed data on age 

and medical conditions for all of the 

settings to which this proposed rule 

would apply. However, a substantial 

majority of hospital patients are middleaged (20 percent ages 45 to 64) or 

elderly (40 percent ages 65 or older), 

and hospital patients account for almost 

half of those that this proposed rule 

would affect. 

Based on its own conclusions from 

recent research, ACIP recommends 

seasonal influenza vaccination at all 

ages (for a highly detailed discussion, 

see ‘‘Prevention and Control of Seasonal 

Influenza with Vaccines,’’ op cit, pages 

27–28): ‘‘Influenza vaccine should be 

provided to all persons who want to 

reduce the risk for becoming ill with 

influenza or of transmitting it to others. 

However, emphasis on providing 

routine vaccination annually to certain 

groups at higher risk for influenza 

infection or complications is advised, 

including all children aged 6 months–18 

years, all persons aged greater than 50 

years, and other adults at risk for 

medical complications from influenza.’’ 

Recent literature suggests the benefits 

of vaccination for influenza would 

outweigh costs for populations of all 

ages, regardless of overall risk categories 

(of course, vaccination would be 

contraindicated for some specific 

patients; these are broad population 

estimates). 

Another recent study put the potential 

economic and life saving benefits of 

vaccination in clear perspective 

(Molinari, Noelle-Angelique, et al., ‘‘The 

Annual Impact of Seasonal Influenza in 

the U.S.: Measuring Disease Burden and 

Costs,’’ Vaccine 25 (2007), pages 5086– 

5096). This study calculated the total 

annual economic burden of influenza, 

including medical costs, lost earnings, 

and lost life, at about $87 billion 

annually (in 2003 dollars). 

The effectiveness of vaccination in 

preventing morbidity and mortality 

presents another major uncertainty. 

Among children, for example, it 

depends on which type of vaccine is 

used, and whether one or two doses are 

given, in addition to risk status, 

virulence of the virus in a particular 

year, and how well the vaccine for a 

particular year matches the virus strains 

circulating that year. Study results also 

vary widely because it is difficult to 

control for underlying risk factors. As 

previously discussed in this preamble, 

the patients of both hospitals and health 

centers are disproportionately likely to 

fall in the least healthy categories. The 

ACIP report, ‘‘Prevention and Control of 

Seasonal Influenza with Vaccines,’’ 

compares the results of vaccine 

effectiveness studies and finds typical 

results to fall between 27 and 70 percent 

effectiveness in preventing 

hospitalization for pneumonia and 

influenza among elderly adults. 

The 2005 final rule (70 FR 58834), 

discussed earlier in this preamble, 

estimated that in long term care 

facilities a 16 percent increase in the 

percent vaccinated annually would 

increase the number vaccinated by 

320,000, reduce the number of illnesses 

by 10,000, reduce the number of 

hospitalizations by 5,300, and reduce 

the number of deaths by about 2,300. 

The projected increase in vaccination 

under this proposed rule for persons 

aged 65 or older would be 

approximately 3.2 million persons if we 

assume that 40 percent of 20 million 

persons are aged 65 or older and that 

this population would have an 

additional take up rate of 40 percent. If 

we assume that immunization for the 

hospitalized elderly is roughly half as 

effective in preventing illness compared 

to immunization for the long term care 

population (that is, prevents illness in 

1.5% of the immunized rather than 3%), 

the additional vaccination would result 

in a reduction in number of illnesses in 

this group of about 50,000. If we assume 

that the likelihood of hospitalization is 

somewhat higher in the noninstitutionalized group (those 

institutionalized already receiving 24- 

hour medical care), the reduction in 

illnesses might reduce the number of 

hospitalizations by about 35,000. 

In contrast to the long term care 

situation, however, the same patients 

are unlikely to present to providers and 

suppliers affected by this proposed rule 

year after year (the major exception to 

this point would be ESRD patients). 

Finally, it is unlikely that the risks of 

hospitalization and death are as high in 

the elderly population at large, or even 

the elderly population already 

hospitalized or being served in other 

provider settings, as in long term care 

facilities. Unfortunately, none of the 

existing literature estimates lives saved 

for persons who are already in medical 

care settings, in many cases very ill, as 

contrasted to persons of the same age 

who are not acutely ill or in some cases 

(for example, ESRD patients) 

chronically ill. 

All of these uncertainties are so 

substantial that we cannot estimate with 

any confidence the numbers of lives 

likely to be saved. Likewise, estimates of 

the value of lives saved would not only 

reflect these uncertainties, but also the 

many uncertainties surrounding such 

valuations. Accordingly, we do not 

attempt to estimate in either 

quantitative or dollar terms the very 

substantial life-saving benefits of this 

proposed rule. 

There are also uncertainties 

surrounding the likely reductions in 

morbidity and medical treatment costs 

for these patients, but those are far less. 

Accordingly, we have used adjusted 

estimates from the 2005 rule of $10,000 

per hospitalization to provide a rough 

estimate of future medical care savings. 

By far the largest category of savings, in 

dollar terms, results from 

hospitalizations prevented. In total, we 

estimate medical care savings to be 

approximately $710 million annually, as 

detailed in the analysis that follows. 

F. Distribution of Costs and Benefits 

The estimates presented in this 

analysis are primarily based on 

economic costs and benefits to 

providers and patients. Such estimates 

do not address who pays. In this section 

of the analysis we analyze the likely 

incidence of costs and savings to 

various categories of payers, including 

insurance programs and patients 

themselves. 

Absent detailed data on the rapidity 

and extent of future adjustments, or of 

the rapidity and extent of future 

adjustments in insurance payments (for 

example, to what extent will Medicare 

or other insurance payments to 

hospitals reflect vaccine administration 

costs), it is impossible to make precise 

estimates of the incidence of costs. 


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However, it is likely that about twofifths of the affected patients would be 

elderly Medicare beneficiaries. Because 

Medicare pays less for vaccine than 

other payers, Medicare would therefore 

pay roughly one-fourth of the cost of 

vaccine and vaccine administration 

costs, or about $80 million annually, for 

elderly Medicare patients (some of this 

cost would be borne by the elderly, 

through their share of the Part B 

premium). Assuming that all of the 

hospitalizations prevented among the 

elderly would be Medicare patients, that 

the average cost of an influenza 

hospitalization is on the order of 

$10,000 for Part A costs, and that 35,000 

elderly hospitalizations would be 

avoided, offsetting savings to the 

Medicare program from reduced 

hospitalization would be about $350 

million, less roughly $10 million for the 

Part A deductible, for a net Part A 

saving to the government of $340 

million. There would also be 

ambulatory cost savings. For 

hospitalized patients we assume these 

would average $2,000, for gross savings 

of $50 million and net savings to the 

government of $40 million after cost 

sharing. Assuming 50,000 fewer 

illnesses in this group not leading to 

hospitalization, and an average of one 

visit per patient at an average cost of 

$350, ambulatory savings to Medicare 

for these elderly patients would be 

about $15 million after patient cost 

sharing. These calculations lead to an 

estimate of savings to the government of 

$350 million for Part A patients age 65 

and older, and of $65 million for Part B 

patients 65 and older. The total would 

be $430 million under these 

assumptions and calculations. These 

estimates assume that the numbers of 

hospitalizations and illnesses prevented 

among the elderly would be at slightly 

over half the rate estimated for the long 

term care vaccination program, and are 

correspondingly sensitive to changes in 

this assumption. 

The estimates above are for elderly 

participants in Medicare. However, 

about one-fifth of beneficiaries enrolled 

in Medicare are disabled rather than 

elderly. Assuming that disabled 

beneficiaries are roughly as likely as the 

elderly to use the providers that would 

be affected by this proposed rule, to 

accept the offer, and to benefit (they are 

younger, but less healthy, on average), 

we would expect the savings and cost 

estimates to be roughly 20 percent 

higher than the figures above for the 

Medicare program as a whole. The total 

net savings to the Medicare program 

would be approximately $540 million in 

the first year, based on the assumptions 

above. 

We note that patients would not bear 

directly any of the vaccine or vaccine 

administration costs. Insured patients 

would gain from reductions in both 

inpatient and outpatient incidence of 

influenza-caused treatment through 

reduced coinsurance and copayments 

for the treatments they would otherwise 

receive. The uninsured would gain from 

elimination of inpatient and outpatient 

charges to which they would otherwise 

be exposed. 

Other insurers, including Medicaid, 

would incur costs roughly in proportion 

to their share of the population in the 

settings we propose to cover, and taking 

into account whether they are primary 

or secondary. Absent precise data, we 

think it likely that Medicaid would be 

affected roughly in proportion to its 

coverage of the non-elderly and nondisabled population (for whom 

Medicare is primary), realizing vaccine 

and vaccine administration costs of 

roughly 10 percent of the total. 

Accordingly, Medicaid payments to 

providers would be on the order of $30 

million a year (ten percent of $330 

million in costs incurred by providers). 

These payments would be financed 

through the same Federal and State 

shares as other Medicaid payments for 

these services. Medicaid savings would 

be far lower, proportionally, than 

Medicare costs because the incidence of 

hospitalization among younger 

influenza patients is so much lower. We 

think it reasonable to assume that 

hospitalization savings would roughly 

equal and quite possibly exceed vaccine 

administration costs, so that the net 

effect of the rule on Medicaid costs 

would be close to zero, or even costsaving. We emphasize that these are 

very rough estimates. 

We have no better basis for estimating 

costs or savings to private insurers. 

Overall, we think that they will pay 

about half of the costs of the program. 

Because their enrollees are generally 

below age 65, and if above such age 

have Medicare as primary insurance, 

their savings from reduced medical care 

costs will reflect the far lower incidence 

of influenza morbidity and mortality at 

younger ages, and the correspondingly 

lower potential cost savings. Similar to 

our conclusion for Medicaid, we think 

it reasonable to assume that savings to 

private health plans would likely 

approximate the costs of the program, 

and would in any event have a 

negligible effect on overall costs. Again, 

we emphasize that these are very rough 

estimates. 

Accordingly, as outlined in Table 10, 

all categories of payers would at least 

break even in financial terms, and those 

that disproportionately serve the oldest 

and sickest, notably Medicare, would 

likely achieve substantial savings in 

relation to their costs. 

TABLE 10—DISTRIBUTION OF MEDICAL COSTS AND SAVINGS

[$ In millions] 

Primary payer Gross 

vaccination cost 

Reduced 

treatment 

costs to payers 

Net cost to 

payers 

Medicare .......................................................................................................................... $165 ¥$545 ¥$380 

Medicaid ........................................................................................................................... 35 ¥35 0 

Private Insurance ............................................................................................................. 130 ¥130 0 

Total .......................................................................................................................... 330 ¥710 ¥380 

G. Uncertainty of the Estimated Costs 

and Benefits 

Clearly, both these cost and benefit 

estimates are subject to substantial 

uncertainty. For example, actual rates 

for vaccination may be considerably 

higher or lower than those we have 

estimated. Some covered providers and 

suppliers are already taking the steps, 

incurring the costs, and helping their 

clients attain the life-saving benefits we 

have estimated. However, the 

preponderance of the evidence 

discussed earlier in this preamble 

suggests that the present level of effort 

is low. Due to this and other 

uncertainties, we believe that the costs 

and benefits actually realized under the 

proposed rule could easily be half, or 

double, our estimates. Perhaps the 


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greatest uncertainty lies in our estimate 

that roughly half of the patients who 

would otherwise be unvaccinated will 

accept the vaccination offers made 

under the proposed rule. If the 

incremental proportion were to be only 

one-fourth, both costs and benefits 

would be halved. If almost all patients 

accepted the offers, both costs and 

benefits would be approximately 

doubled. We think both extremes are 

quite unlikely (for example, some 

patients will be firm refusers of vaccine 

no matter how well the offer is made). 

We do not, however, have great 

confidence that the incremental 

percentage will be at or near 50 percent, 

rather than 40 percent or 60 percent. 

Another area of uncertainty is the 

effectiveness of the vaccine in 

preventing influenza, particularly 

among the elderly, with estimates 

quoted previously in this analysis 

ranging from 27 to 70 percent. There 

will be some independent effect from 

the recently issued rule on coverage of 

preventive health services by health 

insurance plans, but that rule contained 

no estimate of resulting vaccination 

improvements and we have no way to 

take those into account in our estimates. 

As another example of the caution that 

should be used in interpreting these 

estimates, dollar estimates of benefits 

depend crucially not only on these takeup rates, but also on the uncertain 

extent to which these types of atypical 

patients would otherwise have been 

hospitalized had they become ill from 

influenza. 

As previously discussed, we do not 

include an estimate in either 

quantitative or dollar terms of the very 

substantial life-saving benefits of this 

proposed rule in our primary estimate. 

However, if as many as 5,000, 10,000, or 

even 20,000 deaths from influenza 

complications could be avoided, even a 

very conservative value per life saved 

could yield many billions of dollars in 

benefits. 

Throughout this analysis, we have 

used rounded numbers to emphasize 

that none of the assumptions, 

calculations, and estimates should be 

taken as precise or certain. We welcome 

comments on all assumptions and 

calculations. 

H. Effects of Pandemic Provisions 

We have not attempted to quantify the 

costs or benefits of the proposed 

requirements regarding preparation for, 

and services under, potential future 

pandemics. We believe that the costs of 

planning and developing procedures for 

such services fall within the estimates 

we have developed for annual 

influenza. The actual costs of 

vaccination, and benefits thereof, are 

essentially unpredictable. No one knows 

when another pandemic may arrive. We 

believe, however, that the potential 

benefits exceed the potential costs to at 

least the same degree as for annual 

influenza. We welcome comments and 

information on this conclusion, and any 

quantitative information that may shed 

more light on costs and benefits. 

I. Alternatives Considered 

We considered other alternatives 

regarding vaccinating patients and 

residents against influenza. 

One alternative would be to keep the 

present rules, as they are written (that 

is, no requirements). The current 

regulations, however, have so far not 

been effective in increasing the annual 

rate of influenza vaccination, with the 

notable and extremely important 

exception of long term care facility 

patients. The increase in percent 

vaccinated in this high-risk group to 

approximately 90 percent (as discussed 

previously) demonstrates unequivocally 

the potency of the ‘‘routine request’’ 

protocol recently applied to that group 

and herein proposed for additional tens 

of millions of patients. 

Outside long term care settings, 

despite the Federal government’s 

unified efforts to increase the 

availability of safe and effective 

vaccines, and despite substantial 

progress in reducing many vaccine 

preventable diseases, many at-risk 

individuals and care-givers are not 

receiving influenza vaccines. Section 

4107 of the Balanced Budget Act of 1997 

extended the influenza vaccination 

campaign being conducted by CMS in 

conjunction with CDC and the National 

Coalition for Adult Immunization 

through fiscal year 2002, authorizing $8 

million for each fiscal year from 1998 to 

2002. Although Medicare 

reimbursement for influenza 

vaccination was increased under this 

legislation, rates of vaccination did not 

improve as anticipated. This suggests 

that neither improved payment nor 

traditional campaigns are likely to lead 

to substantial improvements in annual 

vaccination rates. 

Another alternative would be to 

explore untried ways to educate 

providers on the value of influenza 

vaccines without rulemaking. However, 

as discussed in studies cited earlier in 

this rule, provider education, so far, has 

not been effective in improving 

vaccination rates. 

There are a number of additional 

alternatives that we have considered 

within the context of the proposed rule. 

We have not proposed requiring these 

providers and suppliers to offer 

pneumococcal vaccine, in contrast to 

the 2005 rule for long term care 

facilities. Pneumococcal vaccine is 

recommended for all children less than 

59 months old. In addition, children 

older than 24 months who are at high 

risk of pneumococcal disease, adults 

over the age of 65, and adults under age 

65 with certain risk factors are 

recommended to receive the 

pneumococcal vaccine. While there is a 

large population that could benefit from 

pneumococcal vaccination, the vaccine 

should only be given once or twice, 

depending on the patient’s age. Because 

it is not designed or recommended for 

regular administration, we believe it is 

best provided or prescribed by primary 

care physicians who maintain long-term 

records for patients. We welcome 

comments on this tentative decision, 

and information on any research 

evidence that might bear on the issue. 

The precise timing of vaccination and 

the precise populations to be offered 

vaccination may vary from year to year, 

depending on the availability of 

vaccine. We considered various ways of 

providing flexibility for supply 

problems, and concluded that the best 

way to handle such contingencies 

without having to engage in rulemaking 

annually, or in situations where 

conditions change too rapidly for 

normal rulemaking procedures, would 

be to require that facility planning take 

into account the latest recommendations 

of appropriate expert bodies. 

We considered both expanding and 

contracting the categories of suppliers 

and providers covered in this rule. The 

set we have chosen have in common 

two key factors: (1) in each setting the 

patients present before health care 

providers with staff licensed to provide 

vaccination available at the time and 

location of the encounter, and (2) ready 

access to equipment and storage 

appropriate for handling, controlling, 

and administering vaccine. In contrast, 

home health agency aides (as an 

example) are rarely, if ever, registered 

nurses, and would not normally have 

the means to transport refrigerated 

vaccines. Hospices, while capable of 

administering vaccine, would be 

inappropriate providers for this purpose 

because of the terminal health situations 

faced by their patients. 

We also considered requiring 

providers to offer vaccination only to 

higher risk patients, such as those over 

45 years of age or over 65 years of age. 

A variation would be for providers to 

use medical risk categories, such as 

suppressed immune system or weak 

heart or lung function, to identify 

patients most in need of vaccine 

protection at all ages. We do not 


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25474 Federal Register / Vol. 76, No. 86 / Wednesday, May 4, 2011 / Proposed Rules 

propose such alternatives, but welcome 

comment on them. The reasons for not 

departing from a universal requirement 

are threefold. First, all patient 

categories, even healthy children, have 

now been shown to benefit from 

vaccination. All payers and providers 

roughly break even (or do better) from 

a universal, uniform practice. Second, 

such alternatives add complexity and 

cost if based on diagnostic or other 

medical indicators requiring 

individualized decisions about each 

patient, and are arguably too simplistic 

or arbitrary otherwise. For example, a 

64-year-old may not be any less likely 

to benefit from vaccination than a 65- 

year-old. Third, and of great practical 

importance, if a provider has any 

substantial number of patients in any 

mandatory group (for example, patients 

over age 65), the provider will have to 

do the same planning, develop the same 

protocols, provide the same staff 

training, go through the same vaccine 

ordering and storage procedures, etc. as 

it would if all patients were covered. 

While a precise calculation is difficult, 

it appears that there are significant 

economies of scale and very little 

savings in burden to providers from 

covering all patients. 

We welcome comments on these and 

any other alternatives that would 

improve the rule. 

J. Accounting Statement 

As required by OMB Circular A–4 

(available at http:// 

www.whitehouse.gov/omb/circulars/ 

a004/a-4.pdf), in Table 10, we have 

prepared an accounting statement 

showing the classification of the costs 

and benefits associated with the 

provisions of this proposed rule. The 

accounting statement is based on 

estimates provided in the RIA. Because 

we assume that costs and benefits 

remain constant in real terms over the 

years, the discounted costs and benefits, 

when ‘‘annualized’’ to an average yearly 

amount, are the same as the one year/ 

first year estimates provided throughout 

this analysis. We have used as an 

estimating horizon a 10-year period, 

which is the lowest normally used in 

Regulatory Impact Analyses. We would 

not expect, however, that the estimates 

would in fact remain as projected. As 

emphasized repeatedly throughout this 

analysis, our estimates are very rough 

and we would not be surprised to see 

real world effects that are substantially 

higher or lower. For purposes of this 

table, we have used a low estimate that 

is half our primary estimate, and a high 

estimate that is double our primary 

estimate. 

TABLE 11—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED COSTS AND SAVINGS

[$ In millions] 

Category Primary estimate Low estimate High estimate 

Units 

Year dollars 

Discount 

rate 

(percent) 

Period 

covered * 

Benefits 

Annualized Qualitative 

(Unquantified) Value 

of Lives Saved 

among Patients Immunized.

Thousands of lives 

saved but no precise 

estimate.

Thousands of lives 

saved but no precise 

estimate.

Thousands of lives 

saved but no precise 

estimate.

2011 7 2011–20 

Thousands of lives 

saved but no precise 

estimate.

Thousands of lives 

saved but no precise 

estimate.

Thousands of lives 

saved but no precise 

estimate.

2011 3 2011–20 

Annualized Value of 

Travel and Convenience Savings to Patients Immunized.

$120 ............................ $60 .............................. $240 ............................ 2011 7 2011–20 

$120 ............................ $60 .............................. $240 ............................ 2011 3 2011–20 

Annualized Value of 

Reduced Medical 

Care Costs Incurred 

for Patients Immunized.

$710 ............................ $355 ............................ $1,420 ......................... 2011 7 2011–20 

$710 ............................ $355 ............................ $1,420 ......................... 2011 3 2011–20 

Costs 

Annual Monetized 

Costs to Medical 

Care Providers and 

Suppliers.

$330 ............................ $165 ............................ $660 ............................ 2011 7 2011–20 

$330 ............................ $165 ............................ $660 ............................ 2011 3 2011–20 

Transfers 

Annualized Payments 

to Medical Care Providers and Suppliers 

by Federal Government.

($380) ......................... ($190) ......................... ($760) ......................... 2011 7 2011–20 

($380) ......................... ($190) ......................... ($760) ......................... 2011 3 2011–20 

* The 6-month influenza season begins each fall and ends the next spring, thus falling in two calendar years. The first season covered by this 

proposed rule begins in the fall of 2011. 


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Federal Register / Vol. 76, No. 86 / Wednesday, May 4, 2011 / Proposed Rules 25475 

VII. Regulatory Flexibility Act (RFA) 

The RFA (15 U.S.C. 603(a)), as 

modified by the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (SBREFA) (Pub. L. 104–121), 

requires agencies to determine whether 

proposed or final rules would have a 

significant economic impact on a 

substantial number of small entities 

and, if so, to prepare a Regulatory 

Flexibility Analysis and to identify in 

the notice of proposed rulemaking or 

final rulemaking any regulatory options 

that could mitigate the impact of the 

proposed regulation on small 

businesses. For purposes of the RFA, 

small entities include businesses that 

are small as determined by size 

standards issued by the Small Business 

Administration, nonprofit organizations, 

and small governmental jurisdictions. 

Individuals and States are not included 

in the definition of a small entity. 

For purposes of the RFA, we normally 

assume that all of the entities affected 

by Medicare-related rules are small, 

either by virtue of size or nonprofit 

status. As indicated in the analysis that 

follows, we estimate that most affected 

entities would incur costs of only a few 

thousand dollars a year. In the case of 

hospitals, costs would be somewhat 

higher but would vary primarily with 

patient caseload. The average per 

patient cost we estimate for provider 

costs (approximately $26) is only about 

one fourth of one percent of the average 

hospital cost per stay (approximately 

$10,000). On July 19, 2010, the 

Department of the Treasury, Department 

of Labor, and Department of Health and 

Human Services, published a rule in the 

Federal Register (75 FR 41726) entitled, 

‘‘Interim Final Rules for Group Health 

Plans and Health Insurance Issuers 

Relating to Coverage of Preventive 

Services Under the Patient Protection 

and Affordable Care Act,’’ which 

mandated that health plans in the 

individual and group health insurance 

markets cover a number of preventive 

services, including influenza 

vaccination, at no copayment or 

coinsurance cost to patients. In practice, 

this means that these plans must pay 

providers and suppliers for providing 

such vaccinations. We also have 

information that in the group health 

market virtually all health plans already 

paid providers and suppliers for 

influenza vaccination (John Hunsaker et 

al., ‘‘Health Insurance Plans and 

Immunization: Assessment of Practices 

and Policies, 2005 through 2008,’’ 

Pediatrics, V. 124, December 2009). In 

general, insurance payments to 

providers and suppliers approximate 

the cost of vaccination and may in many 

situations, such as those addressed by 

this proposed rule, be higher. 

As a result, we do not believe that this 

rule would have a significant economic 

impact on a substantial number of small 

entities, and we certify that an Initial 

Regulatory Flexibility Analysis is not 

required. In the particular case of 

Federally qualified health centers, used 

by many uninsured patients, average per 

patient costs are only about $600 

annually, and $26 represents about a 1 

percent increase in patient costs 

assuming that one-fifth of all patients 

would be vaccinated above baseline 

levels (these centers are already 

encouraged and able to provide 

influenza vaccine to their patients). 

While this amount is substantial, it is 

not close to the 3 to 4 percent cost 

increase that HHS normally uses as the 

threshold of economic significance for 

RFA purposes if these providers had to 

absorb this cost. Both RHCs and FQHCs 

operate, moreover, under a 

reimbursement scheme called ‘‘All 

Inclusive Reimbursement Rate’’ (AIRR) 

under which Medicare and Medicaid 

pay for all covered services. Since 

vaccinations against influenza are 

covered under both programs, the AIRR 

rates should, over the period of time 

needed for adjustments, soon cover all 

costs of vaccination related to Medicare 

and Medicaid patients, who are about 

one half of the total caseload for these 

provider types. These conclusions 

would remain valid even if provider 

costs were twice as high as those we 

estimate (as discussed previously in the 

analysis, these costs are low compared 

to many estimates in the literature 

because all patients covered by this rule 

are already in provider facilities and we 

estimate only marginal costs). In 

summary, we believe that the proposed 

rule will have little or no consequential 

adverse impact on provider costs, net of 

insurance reimbursement. We further 

note that there will be little or no 

adverse impact on insurance companies, 

since they will recover any cost 

increases through minor rate 

adjustments, and the costs we estimate 

are negligible in proportion to industry 

revenues (further, we believe that few 

affected insurance firms are small 

entities as defined in the RFA). 

Ultimately, all of these costs will be 

borne by the workers or taxpayers who 

pay insurance premiums. We welcome 

comments on these estimates and 

conclusions. 

In addition, section 1102(b) of the Act 

requires us to prepare a regulatory 

impact analysis if a rule may have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. This analysis must conform to 

the provisions of the RFA. For purposes 

of section 1102(b) of the Act, we define 

a small rural hospital as a hospital that 

is located outside of a Metropolitan 

Statistical Area and has fewer than 100 

beds. We do not believe a regulatory 

impact analysis is required here 

because, for the reasons stated above, 

this proposed rule would not have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. 

VIII. Unfunded Mandates Reform Act 

of 1995 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4) requires that agencies assess 

anticipated costs and benefits before 

issuing any rule whose mandates 

require spending in any 1 year of $100 

million in 1995 dollars, updated 

annually for inflation. That threshold 

level is currently approximately $136 

million. This proposed rule would 

impose no mandates on State, local, or 

Tribal governments in the aggregate. It 

would, however, impose gross costs of 

approximately $330 million annually on 

affected providers and suppliers, largely 

offset by third party payments 

(including grants-in-aid), and would, 

therefore, approach this threshold. 

Because of Medicare and Medicaid 

coverage of influenza vaccines and 

vaccine administration cost, and the 

predominant coverage of these costs by 

private plans, a rough estimate would be 

that in the first year almost all vaccine 

costs and at least one half of all other 

costs—$240 million or more—would be 

reimbursed through third party 

payments, leaving a net cost impact on 

providers of approximately $90 million. 

In future years as payment benchmarks 

were adjusted we would expect 

provider costs to drop further. 

Accordingly, we do not believe that this 

proposed rule requires analysis under 

UMRA. Regardless, the analysis we have 

prepared meets the requirements of 

UMRA. 

IX. Federalism 

Executive Order 13132 on Federalism 

establishes certain requirements that an 

agency must meet when it publishes a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

We have determined that this proposed 

rule would not significantly affect the 

rights, roles, or responsibilities of the 

States. This proposed rule would not 

impose substantial direct requirement 

costs on State or local governments, 


sroberts on DSK69SOYB1PROD with PROPOSALS
25476 Federal Register / Vol. 76, No. 86 / Wednesday, May 4, 2011 / Proposed Rules 

preempt State law, or otherwise 

implicate federalism. 

List of Subjects 

42 CFR Part 482 

Grant programs—health, Hospitals, 

Medicaid, Medicare, Reporting and 

recordkeeping requirements. 

42 CFR Part 485 

Grant programs—health, Health 

facilities, Medicaid, Medicare, 

Reporting and recordkeeping 

requirements. 

42 CFR Part 491 

Grant programs—health, Health 

facilities, Medicaid, Medicare Reporting 

and recordkeeping requirements, Rural 

areas. 

42 CFR Part 494 

Health facilities, Kidney diseases, 

Medicare, Reporting and recordkeeping 

requirements. 

For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services proposes to amend 

42 CFR chapter IV as set forth below: 

PART 482—CONDITIONS OF 

PARTICIPATION FOR HOSPITALS 

1. The authority citation for part 482 

continues to read as follows: 

Authority: Secs. 1102, 1871 and 1881 of 

the Social Security Act (42 U.S.C. 1302, 

1395hh, and 1395rr), unless otherwise noted. 

Subpart C—Basic Hospital Functions 

2. In § 482.42, a new paragraph (c) is 

added to read as follows: 

§ 482.42 Condition of participation: 

Infection control. 

* * * * * 

(c) Standard: Influenza vaccinations. 

(1) The hospital must develop and 

implement policies and procedures 

regarding administration of annual and 

pandemic influenza vaccinations. 

Pandemic procedures are to be 

implemented when a pandemic event is 

announced by the Secretary. 

(2) The hospital’s policies and 

procedures must take into account, and 

reflect reasonable consideration of, the 

recommendations in guidelines 

established by nationally recognized 

organizations (including, but not limited 

to, guidelines addressing patients for 

whom vaccination may be prioritized or 

temporarily contraindicated). 

(3) Within its policies and procedures, 

the hospital must ensure all of the 

following, subject to the reasonable 

availability of vaccine and where 

appropriate taking into account the 

condition of particular patients: 

(i) Before receiving the influenza 

vaccination, each patient, or, where 

appropriate, the patient’s representative 

or surrogate (as allowed under State 

law), receives education regarding the 

benefits, risks, and potential side effects 

of the vaccine. 

(ii) Each patient is offered an 

influenza vaccination annually, from 

the time the vaccine is available on or 

after September 1 through the end of 

February of the following year, except 

when such vaccination is medically 

contraindicated or when the patient has 

already been vaccinated during this 

time period. 

(iii) The patient, or, where 

appropriate, the patient’s representative 

or surrogate, has the opportunity to 

decline vaccination. 

(iv) The patient’s health record 

includes documentation that indicates, 

at a minimum, the following: 

(A) The date the patient, or the 

patient’s representative or surrogate, 

was provided education regarding the 

benefits, risks, and potential side effects 

of influenza vaccination. 

(B) The date the patient either 

received the influenza vaccination or 

did not receive the influenza 

vaccination due to medical 

contraindications, previous influenza 

vaccination during the time period, or 

patient refusal. 

PART 485—CONDITIONS OF 

PARTICIPATION: SPECIALIZED 

PROVIDERS 

3. The authority citation for part 485 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395(hh)). 

Subpart F—Conditions of 

Participation—Critical Access 

Hospitals (CAHs) 

4. Section 485.635 is amended by— 

A. Redesignating paragraphs (b) 

through (f) as paragraphs (c) through (g), 

respectively. 

B. Adding a new paragraph (b). 

The revisions and additions read as 

follows: 

§ 485.635 Condition of participation: 

Provision of services. 

* * * * * 

(b) Standard: Influenza vaccinations. 

(1) The CAH must develop and 

implement policies and procedures 

regarding administration of annual and 

pandemic influenza vaccinations. 

Pandemic procedures are to be 

implemented when a pandemic event is 

announced by the Secretary. 

(2) The CAH’s policies and 

procedures must take into account, and 

reflect reasonable consideration of, the 

recommendations in guidelines 

established by nationally recognized 

organizations (including, but not limited 

to, guidelines addressing patients for 

whom vaccination may be prioritized or 

temporarily contraindicated). 

(3) Within its policies and procedures, 

the CAH must ensure all of the 

following, subject to the reasonable 

availability of vaccine and where 

appropriate taking into account the 

condition of particular patients: 

(i) Before receiving the influenza 

vaccination, each patient, or, where 

appropriate, the patient’s representative 

or surrogate (as allowed under State 

law), receives education regarding the 

benefits, risks, and potential side effects 

of the vaccine. 

(ii) Each patient is offered an 

influenza vaccination annually, from 

the time the vaccine is available on or 

after September 1 through the end of 

February of the following year, except 

when such vaccination is medically 

contraindicated or when the patient has 

already been vaccinated during this 

time period. 

(iii) The date the patient, or, where 

appropriate, the patient’s representative 

or surrogate, has the opportunity to 

decline vaccination. 

(iv) The patient’s health record 

includes documentation that indicates, 

at a minimum, the following: 

(A) The date the patient, or the 

patient’s representative or surrogate, 

was provided education regarding the 

benefits, risks, and potential side effects 

of influenza vaccination. 

(B) The date the patient either 

received the influenza vaccination or 

did not receive the influenza 

vaccination due to medical 

contraindications, previous influenza 

vaccination during the time period, or 

patient refusal. 

* * * * * 

PART 491—CERTIFICATION OF 

CERTAIN HEALTH FACILITIES 

5. The authority citation for part 491 

continues to read as follows: 

Authority: Sec. 1102 of the Social Security 

Act (42 U.S.C. 1302); and sec. 353 of the 

Public Health Service Act (42 U.S.C. 263a). 

Subpart A—Rural Health Clinics: 

Conditions for Certification; and FQHC 

Conditions for Coverage 

6. Section 491.9 is amended by— 

A. Redesignating paragraph (d) as 

paragraph (e). 

B. Adding a new paragraph (d). 

The revisions and additions read as 

follows: 


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Federal Register / Vol. 76, No. 86 / Wednesday, May 4, 2011 / Proposed Rules 25477 

§ 491.9 Provision of services. 

* * * * * 

(d) Standard: Influenza vaccinations. 

(1) The clinic or center must develop 

and implement policies and procedures 

regarding administration of annual and 

pandemic influenza vaccination. 

Pandemic procedures are implemented 

when a pandemic event is announced 

by the Secretary. 

(2) The clinic or center’s policies and 

procedures must take into account, and 

reflect reasonable consideration of, the 

recommendations in guidelines 

established by nationally recognized 

organizations (including, but not limited 

to, guidelines addressing patients for 

whom vaccination may be prioritized or 

temporarily contraindicated). 

(3) Within its policies and procedures, 

the clinic or center must ensure all of 

the following, subject to the reasonable 

availability of vaccine and where 

appropriate taking into account the 

condition of particular patients: 

(i) Before receiving the influenza 

vaccination, each patient, or, where 

appropriate, the patient’s representative 

or surrogate (as allowed under State 

law), receives education regarding the 

benefits, risks, and potential side effects 

of the vaccine. 

(ii) Each patient is offered an 

influenza vaccination annually, from 

the time the vaccine is available on or 

after September 1 through the end of 

February of the following year, except 

when such vaccination is medically 

contraindicated or when the patient has 

already been vaccinated during this 

time period. 

(iii) The patient, or, where 

appropriate, the patient’s representative 

or surrogate, has the opportunity to 

decline vaccination. 

(iv) The patient’s health record 

includes documentation that indicates, 

at a minimum, the following: 

(A) The date the patient, or the 

patient’s representative or surrogate, 

was provided education regarding the 

benefits, risks, and potential side effects 

of influenza vaccination; and 

(B) The date the patient either 

received the influenza vaccination or 

did not receive the influenza 

vaccination due to medical 

contraindications, previous influenza 

vaccination during the time period, or 

patient refusal. 

* * * * * 

PART 494—CONDITIONS FOR 

COVERAGE FOR END-STAGE RENAL 

DISEASE FACILITIES 

7. The authority citation for part 494 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395hh). 

Subpart B—Patient Safety 

8. Section 494.30 is amended by 

adding a new paragraph (d) to read as 

follows: 

§ 494.30 Condition: Infection control. 

* * * * * 

(d) Standard: Influenza vaccinations. 

(1) The ESRD facility must develop and 

implement policies and procedures 

regarding administration of annual and 

pandemic influenza vaccinations. 

Pandemic procedures are implemented 

when a pandemic event is announced 

by the Secretary. 

(2) The ESRD facility’s policies and 

procedures must take into account, and 

reflect reasonable consideration of, the 

recommendations in guidelines 

established by nationally recognized 

organizations (including, but not limited 

to, guidelines addressing patients for 

whom vaccination may be prioritized or 

temporarily contraindicated). 

(3) Within its policies and procedures, 

the ESRD facility must ensure all of the 

following, subject to the reasonable 

availability of vaccine and where 

appropriate taking into account the 

condition of particular patients: 

(i) Before receiving the influenza 

vaccination, each patient, or, where 

appropriate, the patient’s representative 

or surrogate (as allowed under State 

law), receives education regarding the 

benefits, risks, and potential side effects 

of the vaccine. 

(ii) Each patient is offered an 

influenza vaccination annually, from 

the time the vaccine is available on or 

after September 1 through the end of 

February of the following year, except 

when such vaccination is medically 

contraindicated or when the patient has 

already been vaccinated during this 

time period. 

(iii) The patient, or, where 

appropriate, the patient’s representative 

or surrogate, has the opportunity to 

decline vaccination. 

(iv) The patient’s health record 

includes documentation that indicates, 

at a minimum, the following: 

(A) The date the patient, or the 

patient’s representative or surrogate, 

was provided education regarding the 

benefits, risks, and potential side effects 

of influenza vaccination; and 

(B) The date the patient either 

received the influenza vaccination or 

did not receive the influenza 

vaccination due to medical 

contraindications, previous influenza 

vaccination during the time period, or 

patient refusal. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program.) (Catalog of Federal 

Domestic Assistance Program No. 93.773, 

Medical Assistance Program.) 

Dated: September 3, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: February 25, 2011. 

Kathleen Sebelius, 

Secretary. 

Editorial Note: This document was 

received in the Office of the Federal Register 

on April 27, 2011. 

[FR Doc. 2011–10646 Filed 4–29–11; 11:15 am] 

BILLING CODE 4120–01–P 


sroberts on DSK69SOYB1PROD with PROPOSALS