Federal Register / Vol. 70, No. 156 / Monday, August 15, 2005 / Proposed Rules 47759

requirements of section 12(d) of the 

National Technology Transfer and 

Advancement Act of 1995 (15 U.S.C. 

272 note) do not apply. As required by 

section 3 of Executive Order 12988 (61 

FR 4729, February 7, 1996), in issuing 

this proposed rule, EPA has taken the 

necessary steps to eliminate drafting 

errors and ambiguity, minimize 

potential litigation, and provide a clear 

legal standard for affected conduct. EPA 

has complied with Executive Order 

12630 (53 FR 8859, March 15, 1988) by 

examining the takings implications of 

the rule in accordance with the 

‘‘Attorney General’s Supplemental 

Guidelines for the Evaluation of Risk 

and Avoidance of Unanticipated 

Takings’’ issued under the executive 

order. This proposed rule pertaining to 

the amendments to the Maryland’s AIM 

coatings rule does not impose an 

information collection burden under the 

provisions of the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501 et seq.).

List of Subjects in 40 CFR Part 52

Environmental protection, Air 

pollution control, Nitrogen dioxide, 

Ozone, Reporting and recordkeeping 

requirements, Volatile organic 

compounds.

Authority: 42 U.S.C. 7401 et seq.

Dated: August 5, 2005. 

Donald S. Welsh, 

Regional Administrator, Region III.

[FR Doc. 05–16111 Filed 8–12–05; 8:45 am] 

BILLING CODE 6560–50–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 483 

[CMS–3198–P] 

RIN 0938–AN95 

Medicare and Medicaid Programs; 

Condition of Participation: 

Immunization Standard for Long Term 

Care Facilities

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS.

ACTION: Proposed rule.

SUMMARY: The goal of this proposed rule 

is to increase immunization rates in 

Medicare and Medicaid participating 

long term care (LTC) facilities by 

requiring LTC facilities to offer each 

resident immunization against influenza 

annually, as well as lifetime 

immunization against pneumococcal 

disease. LTC facilities would be 

required to ensure that each resident 

receives an annual immunization 

against influenza and receives the 

pneumococcal immunization once, 

unless medically contraindicated or the 

resident or the resident’s legal 

representative refuses immunization. 

Increasing the use of Medicare-funded 

preventive services is a goal of both 

CMS and the Centers for Disease Control 

and Prevention (CDC). This proposed 

rule is intended to increase the number 

of elderly receiving influenza and 

pneumococcal immunization and 

decrease the morbidity and mortality 

rate from influenza and pneumococcal 

diseases.

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on August 30, 2005.

ADDRESSES: In commenting, please refer 

to file code CMS–3198–P. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

three ways (no duplicates, please): 

1. Electronically. You may submit 

electronic comments on specific issues 

in this regulation to http://

www.cms.hhs.gov/regulations/

ecomments. (Attachments should be in 

Microsoft Word, WordPerfect, or Excel; 

however, we prefer Microsoft Word.) 

2. By regular mail. You may mail 

written comments (one original and two 

copies) to the following address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–3198–

P, P.O. Box 8010, Baltimore, MD 21244–

8010. 

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 (one 

original and two copies) to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–3198–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 (one original 

and two copies) before the close of the 

comment period to one of the following 

addresses. 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. 

Room 445–G, Hubert H. Humphrey 

Building, 200 Independence Avenue, 

SW., Washington, DC 20201; or 7500 

Security Boulevard, Baltimore, MD 

21244–1850.

(Because access to the interior of the HHH 

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.)

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:

Anita Panicker, (410) 786–5646. Jeannie 

Miller, (410) 786–3164. Rachael 

Weinstein, (410) 786–6775.

SUPPLEMENTARY INFORMATION: 

Submitting Comments: We welcome 

comments from the public on all issues 

set forth in this rule to assist us in fully 

considering issues and developing 

policies. You can assist us by 

referencing the file code CMS–3198–P 

and the specific ‘‘issue identifier’’ that 

precedes the section on which you 

choose to comment. 

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. CMS posts all electronic 

comments received before the close of 

the comment period on its public Web 

site as soon as possible after they have 

been received. Hard copy comments 

received timely will 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

(If you choose to comment on issues in this 

section, please include the caption 

‘‘BACKGROUND’’ at the beginning of your 

comments.)

A. General 

The CDC’s Advisory Committee on 

Immunization Practices (ACIP) reported 

on May 28, 2004 (http://www.cdc.gov/

mmwr/preview/mmwrhtml/

47760 Federal Register / Vol. 70, No. 156 / Monday, August 15, 2005 / Proposed Rules 

rr5306a1.htm), that epidemics of 

influenza have been responsible for an 

average of approximately 36,000 deaths 

per year in the United States between 

1990 and 1999. There is an added 

danger when it comes to people age 65 

or older or with high risk conditions 

such as individuals residing in long 

term care facilities. In 2002, ACIP 

estimated the rates of influenza related 

hospitalization as 392 to 635 per 

100,000 among adults with one or more 

high risk conditions, compared to 13 to 

33 per 100,000 among those without 

high risk conditions. 

According to the CDC, influenza and 

invasive pneumococcal disease kill 

more people in the United States each 

year than all other vaccine-preventable 

diseases combined. Influenza and 

pneumonia combined represent the fifth 

leading cause of death in the elderly. 

Immunization is the primary method for 

preventing invasive pneumococcal 

disease as well as influenza and its more 

severe complications. The ACIP 

reported in 2002 that the primary target 

group for influenza vaccination includes 

persons who are at high risk for serious 

complications from influenza, including 

approximately 35 million persons who 

are more than 65 years of age and 

approximately 33 to 39 million persons 

less than 65 years of age who have 

chronic underlying medical conditions. 

ACIP recommends that all residents of 

long term care facilities should be 

assessed for their needs for 

pneumococcal polysaccharide vaccine 

(PPV) and that people 65 or older, as 

well as persons less than 65 who have 

chronic illness or who are living in long 

term care facilities, receive the 

immunization if eligible. As the vast 

majority of the residents in nursing 

homes are 65 years and older, or if 

younger, probably have one or more 

chronic medical conditions for which 

the vaccine is indicated, one would 

expect that nearly all residents are 

candidates for pneumococcal 

vaccination. Therefore, it is vital to 

increase immunization rates to reduce 

and eliminate vaccine-preventable 

causes of morbidity and mortality. 

Despite the Federal government’s 

unified efforts to increase the 

availability of safe and effective 

vaccines and despite substantial 

progress in reducing many vaccinepreventable diseases, many individuals 

are not receiving influenza and 

pneumococcal vaccines. 

Section 4107 of the Balanced Budget 

Act of 1997 extended the influenza and 

pneumococcal immunization 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 

and pneumococcal immunizations was 

increased under this legislation, rates of 

immunization did not improve as 

anticipated. 

On April 30, 1999, the CDC and CMS 

entered into a memorandum of 

understanding (IA 99–87), to establish a 

program of collaboration between the 

two agencies to enhance assessment of 

health status and delivery of preventive 

services to beneficiaries of the Medicare 

program. One of the initial areas 

highlighted for collaboration was 

improving influenza and pneumococcal 

immunization coverage through 

‘‘standing orders’’ for those populations 

and in those settings designated as 

appropriate by the ACIP. 

A March 24, 2000 ACIP report 

recommended the use of standing orders 

programs in both outpatient and 

inpatient settings to increase the 

number of individuals who receive the 

influenza vaccine (http://www.cdc.gov/

mmwr/preview/mmwrhtml/

rr4901a1.htm). On October 2, 2002 (67 

FR 61808), CMS published a final rule 

with comment period that removed the 

physician order requirement for 

influenza and pneumococcal 

vaccinations from the Conditions of 

Participation (CoPs) for Medicare and 

Medicaid participating hospitals, (LTC) 

facilities, and home health agencies 

(HHAs). The final rule was effective as 

of its publication date. Although the 

CoPs for these provider types require a 

physician’s order for drugs and 

biologicals that must be signed by the 

practitioner responsible for the care of 

the patient or resident, the CoPs make 

an exception for influenza and PPV. 

These vaccines now can be 

administered per a physician-approved 

facility or agency policy, following 

assessment of the patient or resident for 

contraindications. The final rule was a 

major step towards increasing the 

immunization rates in the LTC 

population. 

To date we do not have data on the 

specific immunization rates of nursing 

facility residents since the publication 

of this rule. Medicare Current 

Beneficiary Survey (MCBS) data shows 

that, the rate of influenza vaccination of 

individuals age 65 and older was 70.4 

percent in the year 2000, 67.4 percent in 

2001, 69 percent in 2002 and 70.4 

percent in 2003. MCBS data for 

pneumococcal vaccination for 

individuals age 65 and older was 62.7 

percent in 2000, 63.3 percent in 2001, 

64.6 percent in 2002 and 66.4 percent in 

2003. These rates demonstrate that we 

need to implement strategies to help us 

achieve the goal set by the Department 

of Health and Human Services (DHHS) 

Healthy People 2010, which set a target 

rate of 90 percent for influenza and 

pneumococcal vaccination for adults 

aged 65 years and older. Further 

information on preventive services like 

immunizations are available at the 

healthy aging site at http://

www.cms.hhs.gov/healthyaging/2a.asp

and at http://www.healthypeople.gov/. 

B. Influenza Incidence and Prevention 

Numerous studies referenced by the 

CDC at the Morbidity and Mortality 

Weekly Report (MMWR) website show 

that: (1) Persons 65 years and older are 

at high risk of contracting influenza, (2) 

they are more likely than the general 

population to need hospitalization or to 

die from complications of influenza, 

and (3) immunizations are effective in 

preventing influenza and its 

complications in this population (http:/

/www.cdc.gov/mmwr/preview/

mmwrhtml/rr5306a1.htm). 

In the May 2004 MMWR referenced 

above, the ACIP stated that while rates 

of influenza infection are high among 

children, rates of serious illness and 

death are highest among persons aged 

≥65 years and persons of any age who 

have medical conditions that place them 

at increased risk for complications from 

influenza. According to ACIP, the 

primary target groups recommended for 

annual vaccination are as follows: (1) 

Persons at increased risk for influenzarelated complications (for example, 

those aged ≥65 years and persons of any 

age with certain chronic medical 

conditions); (2) persons aged 50 to 64 

years (because this group has an 

elevated prevalence of certain chronic 

medical conditions); and (3) persons 

who live with or care for persons at high 

risk (for example, health-care workers 

and individuals within a household 

who have frequent contact with persons 

at high risk and who can transmit 

influenza to those persons at high risk).

The ACIP report states that 

vaccination is associated with 

reductions in influenza-related 

respiratory illness and physician visits 

among all age groups, hospitalization 

and death among persons at high risk, 

otitis media among children, and work 

absenteeism among adults. Although 

influenza vaccination levels increased 

substantially during the 1990s, further 

improvements in vaccine coverage 

levels are needed. Influenza vaccination 

remains the cornerstone for the control 

and treatment of influenza. (MMWR: 

Recommendations and Reports May 28, 

2004/53(RR06); 1–40 http://

www.cdc.gov/mmwr/preview/

mmwrhtml/rr5306a1.htm).

Federal Register / Vol. 70, No. 156 / Monday, August 15, 2005 / Proposed Rules 47761

Although influenza affects persons of 

all ages, the CDC has identified several 

groups who are at increased risk for 

complications. One such group is 

comprised of residents of nursing homes 

or other long-term care facilities. An 

article in American Family Physician, 

January 1, 2002 titled, ‘‘Influenza in the 

Nursing Home,’’ states that during 

influenza epidemics, mortality rates 

among nursing home residents often 

exceed 5 percent of the nursing home 

population in the country. To lessen the 

impact of this infectious disease, the 

CDC recommends the influenza vaccine 

as the primary way of preventing the 

illness and its complications (http://

www.aafp.org/afp/20020101/75.html). 

The Director of Health Care-Public 

Health Issues for the General 

Accountability Office (GAO) testified 

before the United States Senate Special 

Committee on Aging, on September 28, 

concerning a 2004 GAO study titled, 

‘‘Infectious Disease Preparedness: 

Federal Challenges in Responding to 

Influenza Outbreaks’’ (http://

www.gao.gov/new.items/d041100t.pdf). 

She stated that the study was conducted 

to identify the challenges in preventing 

the spread of the influenza virus 

because influenza is associated with an 

average of 36,000 deaths and more than 

200,000 hospitalizations each year in 

the United States. Furthermore, nine out 

of ten persons who die from influenza 

and one out of two who are hospitalized 

due to influenza are age 65 or older. The 

GAO was asked to conduct the study to 

assess issues related to supply, demand, 

and distribution of vaccine during a 

typical flu season and to assess the 

Federal plan to respond to an influenza 

pandemic. The study was based on a 

survey of physician group practices, 

interviews with health department 

officials in all 50 states, as well as 

information about CDC activities in the 

2003–04 flu season. The GAO found 

that the most effective way to prevent 

influenza is by immunizing individuals 

against influenza every fall season. 

The 2004 ACIP recommendations 

referenced earlier state that influenza 

vaccine effectiveness varies in the 

elderly; however, influenza vaccine is 

still effective at preventing severe 

illness, secondary complications, and 

death. In the elderly population residing 

in nursing homes, the vaccine can be 

50–60 percent effective in preventing 

hospitalization or pneumonia and 80 

percent effective in preventing death, 

even though the effectiveness in 

preventing influenza illness often ranges 

from 30 percent to 40 percent. 

According to the January 1, 2002 

article in American Family Physician 

referenced earlier, a number of studies 

have also shown that nursing homes 

with high rates of vaccinated residents 

have fewer outbreaks of influenza than 

nursing homes with lower vaccination 

rates. The article further states that 

many studies have shown that influenza 

vaccination of nursing home residents 

and staff can significantly decrease rates 

of hospitalization, pneumonia, and 

related mortality. Therefore, it is vital to 

the well being of the residents of 

nursing homes that they are offered 

immunization, if not medically 

contraindicated, and that facilities 

ensure residents receive the 

immunizations at the appropriate time 

to prevent the spread of the influenza 

virus. 

The February 14, 2005, article in the 

Archives of Internal Medicine titled 

‘‘Impact of Influenza Vaccination on 

Seasonal Mortality in the U.S. Elderly 

Population’’ reports the results of the 

study conducted by Lone Simonsen and 

colleagues on flu vaccination rates 

among elderly (http://archinte.amaassn.org/cgi/content/abstract/165/3/

265). This study reports that vaccination 

of the elderly population against 

influenza may be less effective in 

preventing death among the elderly than 

previously estimated. CDC and National 

Institute of Health (NIH) jointly, in a 

February 15, 2005, press release

(http://www.cdc.gov/flu/pdf/

statementeldmortality.pdf) concluded 

that the Simonsen, et al. study does not 

show that the flu vaccine is ineffective 

at protecting the elderly from influenza. 

Rather, the study indicates that different 

research approaches result in different 

estimates of influenza vaccine 

effectiveness at preventing death among 

the elderly. 

The Simonsen, et al., study does not 

imply that the elderly should not 

receive influenza vaccine. Furthermore, 

we note that this study addresses the 

elderly population as a whole, and does 

not analyze the more vulnerable group, 

nursing home residents, addressed by 

this regulation and the studies of those 

residents summarized later in this 

preamble. The conclusions in the study 

are in sharp contrast to other peerreviewed studies that address the same 

issue (see for example, JAMA; Chicago; 

Oct 22–Oct 29, 1997; 278; 16; Jane E 

Sisk; Alan J Moskowitz; William 

Whang; Jean D Lin et al.). The CDC and 

ACIP continually review their influenza 

vaccine recommendations as well as 

studies and published research in order 

to develop the best recommendations 

for protecting all Americans from 

influenza. The Simonsen, et al., study is 

a reminder that there is room for 

improvement in how we protect the 

elderly from influenza, and CDC and 

NIH encourage research that strengthens 

our ability to do so. 

The CDC continues to recommend 

that people aged 65 and older get 

vaccinated against influenza each year 

as persons aged 65 and older are at high 

risk for complications, hospitalizations, 

and deaths from influenza. In the joint 

press release referenced above, the CDC 

and National Institute of Health (NIH) 

continue to support the ACIP 

recommendation that people aged 65 

and older get vaccinated against 

influenza each year. 

C. Pneumococcal Disease Incidence and 

Prevention 

Like influenza, invasive 

pneumococcal disease is particularly 

prevalent and severe in those 65 years 

and older. This population is at high 

risk of contracting invasive 

pneumococcal disease, with a high risk 

of resultant complications, 

hospitalizations, and deaths. 

Pneumococcal immunizations are 

effective in preventing pneumococcal 

disease in this population. 

According to CDC’s Active Bacterial 

Core Surveillance for pneumococcal 

disease, approximately 5,700 deaths 

from invasive pneumococcal disease 

(bacteremia and meningitis) are 

estimated to have occurred in the 

United States in 2002 (http://

www.cdc.gov/ncidod/dbmd/abcs/

survreports/spneu02.pdf). An article in 

the American Journal of Preventive 

Medicine, August 2003, titled 

‘‘Standards for Adult Immunization 

Practices’’ states that overall, vaccine 

effectiveness against invasive 

pneumococcal disease among 

immunocompetent people aged 65 years 

is 75 percent. Based on 1998 

projections, annually, 76 percent of 

invasive pneumococcal disease cases 

and 87 percent of resulting deaths 

occurred in people who were eligible for 

pneumococcal vaccine in the United 

States. (http://www.cdc.gov/nip/recs/

rev_stds_adult_AJPM.pdf)

The ACIP and CDC recommend 

immunization for pneumococcal disease 

for those 65 years old or older, and for 

people with a serious long-term health 

problem, such as heart disease, diabetes, 

or immunosuppression due to disease, 

organ transplantation, or medical 

treatment such as chemotherapy. The 

American Lung Association warns that 

people considered at high risk for 

invasive pneumococcal disease include 

the elderly, the very young, and those 

with underlying health problems, such 

as chronic obstructive pulmonary 

disease (COPD). Patients with diseases 

that impair the immune system, such as 

AIDS, or patients with other chronic

47762 Federal Register / Vol. 70, No. 156 / Monday, August 15, 2005 / Proposed Rules 

illnesses, such as asthma, or those 

undergoing cancer therapy or organ 

transplantation, are particularly 

vulnerable. 

According to CDC recommendations, 

usually one dose of the PPV is all that 

is needed to prevent pneumococcal 

disease or a person only needs to be 

immunized once in a life time. 

However, a second dose is 

recommended for people 65 and older 

who received their first dose prior to 65 

years of age, if five or more years have 

passed since that dose. A second dose 

is also recommended for people with a 

damaged spleen or without a spleen, 

sickle-cell disease, HIV infection or 

AIDS, cancer, leukemia, lymphoma, 

multiplemyeloma, kidney failure or 

nephrotic syndrome, an organ or bone 

marrow transplant, or who are taking 

medication that lowers immunity (such 

as chemotherapy or long-term steroids). 

Accordingly, we believe it vital that 

facilities secure the consent of their 

residents or legal representative for 

vaccination and provide their residents 

with vaccinations. In some cases, this 

may require that they educate residents 

about the advantages of being 

vaccinated so that the residents will 

understand the risks of pneumococcal 

infections and will be willing to receive 

the vaccine. The 1997 ACIP 

recommendations state that, 

‘‘Pneumococcal polysaccharide vaccine 

generally is considered safe based on 

clinical experience since 1977, when 

the pneumococcal polysaccharide 

vaccine was licensed in the United 

States. Approximately half of the 

persons who receive pneumococcal 

vaccine develop mild, local side effects 

(for example, pain at the injection site, 

erythema, and swelling). These 

reactions usually persist for less than 48 

hours. Moderate systemic reactions (for 

example, fever and myalgias) and more 

severe local reactions (for example, local 

induration) are rare. Severe systemic 

adverse effects (for example, 

anaphylactic reactions) rarely have been 

reported after administration of 

pneumococcal vaccine. In a recent metaanalysis of nine randomized controlled 

trials of pneumococcal vaccine efficacy, 

local reactions were observed among 

approximately one third or fewer of 

7,531 patients receiving the vaccine, 

and there were no reports of severe 

febrile or anaphylactic reactions.’’ The 

1997 ACIP recommendations further 

state that pneumococcal vaccination has 

not been causally associated with death 

among vaccine recipients. Additional 

information about precautions and 

contraindications can be attained from 

CDC and the vaccine manufacturer’s 

package insert should also be reviewed. 

(http://www.cdc.gov/mmwr/preview/

mmwrhtml/

00047135.htm#00002349.htm). 

CDC’s March 24, 2000 MMWR states 

that in recent years, a rapid emergence 

of antimicrobial resistance among 

pneumococci, especially to penicillin, 

has occurred. Increasing pneumococcal 

vaccination rates could help prevent 

invasive pneumococcal disease caused 

by vaccine-type, multidrug-resistant 

pneumococci. Outbreaks of 

pneumococcal disease caused by a 

single drug resistant pneumococcal 

serotype have occurred in institutional 

settings, including nursing homes. The 

same MMWR report states that in 1999, 

because of concerns about 

pneumococcal antimicrobial resistance 

and underuse of pneumococcal vaccine, 

the American Medical Association and 

several partner organizations issued a 

Quality Care Alert that supports ACIP’s 

recommendations for pneumococcal 

vaccination. (Use of Standing Orders 

Programs to Increase Adult Vaccination 

Rates: MMWR 2000/49 RR01 15–26 

March 24.) 

A CMS/CDC report, ‘‘Respiratory 

Disease Burden in Nursing Homes’’

(http://www.nationalpneumonia.org/

sop/RDBNH_INTERIMProjectRpt_1–31–

03.pdf) states that both influenza 

vaccine and PPV are protective to 

residents in nursing homes. Based on 

two years of analysis (multivariate/

multilevel), influenza vaccine may be 

associated with a 27 to 35 percent 

reduction in mortality, and a 44 to 52 

percent reduction in all-cause 

hospitalization. Similarly, 

pneumococcal vaccination may be 

associated with a 20 to 26 percent 

reduction in mortality, and a 12 to 28 

percent reduction in all-cause 

hospitalization in nursing home 

residents. The report also suggests that 

a facility-level influenza vaccination of 

80 percent of residents may be 

independently associated with reduced 

patient hospitalization and death. 

D. Why a Change in the Conditions of 

Participation Is Needed 

In January 2000, the Department of 

Health and Human Services launched 

Healthy People 2010, a comprehensive, 

nationwide health promotion and 

disease prevention agenda. 

‘‘Immunizations and Infectious 

Diseases’’ is one of the focus areas. 

Healthy People 2010 set the target rate 

for influenza and PPV vaccination of 

adults aged 65 years and older at 90 

percent. According to CMS’s Adult 

Immunization Project ‘‘despite the fact 

that influenza and pneumococcal 

vaccines are clinically effective, costeffective, and are Medicare Part B 

covered benefits, they remain 

underutilized’’ (http://www.ofmq.com/

user_uploads/National%

20Immunization%20Project.pdf). 

Based on the 1999 National Nursing 

Home Survey, only 66 percent of 

nursing home residents had received the 

influenza vaccine in the previous year 

and only 38 percent had ever had the 

pneumococcal vaccine. The October 

2004 article in the American Family 

Physician titled ‘‘Pneumonia in Older 

Residents of Long-Term Care Facilities’’

stated that, when compared to persons 

in the overall community, residents in 

LTC facilities have more functional 

disabilities and underlying medical 

illnesses and are at increased risk of 

acquiring infectious diseases (http://

www.aafp.org/afp/20041015/

1495.html). Risk factors include unwitnessed aspiration, sedative 

medication, and co-morbid illnesses. 

Influenza-associated mortality is a major 

concern for persons with chronic 

diseases; this mortality increase is most 

marked in persons 65 years of age or 

older, with more than 90 percent of the 

deaths attributed to pneumonia and 

influenza occurring in persons of this 

age group. 

As noted in the October 15, 2004 

article ‘‘Pneumonia in Older Residents 

of Long-Term Care Facilities’’ in the 

journal of American Family Physician, 

October 15, 2004, ‘‘The number of frail 

older adults living in LTC facility is 

expected to increase dramatically over 

the next 30 years’’ (http://www.aafp.org/

afp/20041015/1495.html). The article 

further states that an estimated 40 

percent of adults will spend some time 

in a LTC facility before dying. Unless 

control measures are more vigorously 

implemented, the number of deaths 

from influenza and pneumonia with 

respect to residents in LTC facilities and 

the number of consequent 

complications might increase 

significantly.

In summary, immunizations save 

lives and can help avoid needless 

suffering and unnecessary costs caused 

by complications from various 

infectious diseases, and, as many family 

members and health care workers know, 

they can prevent infection of others. 

However, despite the availability of safe 

and effective vaccines, substantial 

portions of susceptible adults are not 

being immunized. To reduce morbidity 

and mortality rates, delivering 

appropriate vaccinations in a timely 

manner is vital. This rule would 

facilitate the delivery of appropriate 

vaccinations to residents in LTC 

facilities in a timely manner and 

increase vaccination rates, and thereby 

decrease the morbidity and mortality

Federal Register / Vol. 70, No. 156 / Monday, August 15, 2005 / Proposed Rules 47763

rate of influenza and pneumococcal 

diseases. This rule also has the potential 

to reduce overall healthcare costs by 

reducing the need for the treatment of 

influenza and pneumococcal diseases 

and their complications. 

E. Immunizations and LTC Facilities 

According to a June 2002 CDC 

summary of the National Nursing Home 

Survey, 46,000 nursing home residents 

(2.5 percent) had pneumonia in 1999. 

The average length of stay in a LTC 

facility for a resident with pneumonia as 

a primary diagnosis was 124 days in 

1999 (http://www.cdc.gov/nchs/data/

series/sr_13/sr13_152.pdf). 

A November 2000 article in the 

journal Infection Control and Hospital 

Epidemiology titled ‘‘Increasing 

Pneumococcal Vaccination Rates 

Among Residents of Long-Term Care 

Facilities,’’ noted that there were 

1,590,763 individuals over 65 years of 

age residing in LTC facilities in the 

United States in 1990, and the number 

is estimated to grow to 2.9 million by 

2020 (Infection Control and Hospital 

Epidemiology, Volume 21 (11) (705–

710) November 2000). A substantial 

increase in vaccination rates among 

such a large population would 

significantly decrease the number of 

cases of influenza and pneumococcal 

bacteremia and related death. 

A 1999 RAND report stated that the 

proportion of the U.S. population over 

age 65 had increased from 5 percent in 

1900 to 13 percent in 1997. This change 

in demographics, combined with an 

increase in average life expectancy, has 

highlighted the importance of 

preventive care services for older 

individuals. The October 1997 Journal 

of the American Medical Association 

(JAMA) article ‘‘Cost-Effectiveness of 

Vaccination Against Pneumococcal 

Bacteremia Among Elderly People’’

indicated that vaccination of elderly 

people against pneumococcal 

bacteremia is one of the few 

interventions that have been found to 

both improve health and save medical 

costs. Vaccination both reduced medical 

expenses and improved health for the 

overall age group of 65 years and older 

(JAMA; Chicago; Oct 22-Oct 29 1997; 

278; 16; Jane E Sisk; Alan J Moskowitz; 

William Whang; Jean D Lin et al.). The 

article further states ‘‘Vaccination of the 

23 million elderly people unvaccinated 

in 1993 would have gained about 78,000 

years of healthy life and saved $194 

million.’’

Pneumococcal vaccination saves costs 

in the prevention of bacteremia alone 

and is greatly underused among the 

elderly population, on both health and 

economic grounds. These results 

support recent recommendations of the 

ACIP and public and private efforts 

under way to improve vaccination rates 

F. Vaccine Shortages 

In the fall of 2004 there was a major 

shortage of inactivated influenza 

vaccine in the United States. One of the 

major manufacturers of the influenza 

vaccine informed the CDC in early 

October 2004 that none of its flu vaccine 

would be available for distribution in 

the United States. Because of the 

shortage, Federal health officials 

released new guidelines as to who 

should receive a flu vaccine, describing 

those at high-risk of influenza-related 

health complications as priority groups. 

At that time, the interim 

recommendations from CDC stated that 

people 65 and older, as well as all those 

between the ages of 2 to 64 with chronic 

medical conditions and 6–23 month old 

children, were to be prioritized for 

receiving influenza vaccination. Other 

groups deemed a priority were nursing 

homes residents. We understand that 

providers of LTC services may be 

concerned about how they would meet 

the requirements of this regulation 

should an influenza vaccine shortage 

occur in the future. In the case of a true 

vaccine shortage as declared by CDC, 

CMS could exercise its enforcement 

discretion by instructing the State 

Survey Agencies (SSAs) not to cite 

facilities as out-of-compliance with this 

requirement if they were unable to 

obtain vaccine for their residents. 

II. Provisions of the Proposed Rule 

On May 28, 2004, the ACIP 

recommendations on ‘‘Prevention and 

Control of Influenza’’ (http://

www.cdc.gov/mmwr/preview/

mmwrhtml/rr5306a1.htm), outlined the 

requirements for a successful 

vaccination program, including 

combined publicity and education for 

health-care workers and other potential 

vaccine recipients; a plan for identifying 

persons at high risk; use of reminder/

recall systems; and efforts to remove 

administrative and financial barriers 

that prevent persons from receiving the 

vaccines, including use of standing 

orders programs. We propose to add 

§ 483.25 (n), that would require LTC 

facilities to offer each resident between, 

October 1 through March 31, 

immunization against influenza 

annually, as well as lifetime 

immunization against pneumococcal 

disease. LTC facilities would be 

required to ensure that each resident 

receives an annual immunization 

against influenza and receives the 

pneumococcal immunization unless 

medically contraindicated, based on an 

assessment, or unless the resident or the 

resident’s legal representative refuses 

consent. As an alternative, a second 

pneumococcal shot may be given 5 

years after the first pneumococcal 

immunization if the vaccine was 

administered prior to age 65, and only 

according to a practitioner 

recommendation.

We are not proposing to require the 

development of protocols nor specific 

documentation. However, as a facility 

develops and implements immunization 

protocols or procedures, we expect that 

obtaining previous immunization 

history on each resident, when possible, 

would be a part of the process. 

Additionally, this rule proposes that the 

resident’s immunization status be 

documented in the resident’s medical 

record including but not limited to the 

information that the resident received 

influenza or/and pneumococcal 

immunization, or immunization was 

medically contraindicated, or 

immunization was refused. If the 

immunization was refused, 

documention must include that the 

resident or the resident’s legal 

representative received appropriate 

education and consultation regarding 

the benefits of influenza and 

pneumococcal immunization. Updating 

and maintaining resident medical 

records related to immunization was 

identified as an issue by the CDC. The 

National Nursing Home Survey (NNHS), 

conducted in 1995 by the CDC, National 

Center for Health Statistics, indicated 

that a large number of nursing facilities 

did not maintain complete, easilyaccessible information on the 

vaccination status of their residents. 

Nearly 21 percent of the nursing home 

residents did not have documentation 

regarding influenza vaccination, and 43 

percent did not have documentation 

regarding pneumococcal vaccination. 

Thus, it was difficult to reliably estimate 

levels of influenza and pneumococcal 

vaccine use among nursing home 

residents in 1995. The 1995 NNHS also 

indicated that facilities with an 

organized immunization program had 

higher immunization rates than those 

without a program. To encourage the 

development of organized 

immunization programs in long-term 

care facilities, CDC created a ‘‘how to’’

manual. The manual outlines general 

recommendations for establishing 

immunization programs that should 

integrate seamlessly into the facility’s 

overall policies and procedures for 

quality care. The manual is available on 

line at http://www.cdc.gov/nip/

publications/long-term-care.pdf.

The March 18, 2005 CDC manual 

titled ‘‘Prevention and Control of

47764 Federal Register / Vol. 70, No. 156 / Monday, August 15, 2005 / Proposed Rules 

Vaccine-Preventable Diseases in LongTerm Care Facilities,’’ Section IV, 

focuses on the ACIP recommendation 

related to ‘‘staff immunization to reduce 

staff illnesses during the influenza 

season to reduce the spread of influenza 

from workers to residents’’ (http://

www.cdc.gov/nip/publications/longterm-care.pdf). We acknowledge the 

importance of staff immunization. In a 

similar vein, our infection control 

requirements at 42 CFR 483.65(b)(2) 

state that ‘‘The facility must prohibit 

employees with a communicable 

disease or infected skin lesions from 

direct contact with residents or their 

food, if direct contact will transmit the 

disease.’’ The intent of this regulation is 

to prevent the spread of communicable 

diseases from employees to residents. 

Influenza immunizations are given 

annually. ACIP (May 27, 1994) 

recommends that during October and 

November each year, vaccination should 

be routinely provided to all residents of 

chronic-care facilities with the 

concurrence of attending physicians. 

Consent is required for vaccination and 

can be obtained from the resident or 

their legal representative at the time of 

admission to the facility or anytime 

afterwards. When possible, all residents 

should be vaccinated at the beginning of 

the influenza season. Residents 

admitted after the influenza season 

begins, must be vaccinated at the time 

of admission until the end of March 

(ACIP, May 27, 1994). Therefore, we 

propose that all residents be offered 

immunization annually from October 1 

through March 31. We hope to have this 

rule finalized by October 1, 2005, before 

the 2005–2006 influenza season. 

PPV is given once in a life time, with 

certain exceptions. This proposed rule 

recognizes the exception by including 

language about a second shot at 

§ 483.25(n)(2)(iv). This exception states, 

a second shot may be given 5 years after 

the first pneumococcal immunization if 

the vaccine was administered before age 

65 and only according to a practitioner 

recommendation. The following is a 

simple algorithm ACIP recommends for 

pneumococcal polysaccharide vaccine.

For further information, please go to 

the CDC Web site listed below: http://

www.cdc.gov/mmwr/preview/

mmwrhtml/

00047135.htm#00001211.gif.

Facilities must assess residents for 

medical contraindications before 

immunizing them to prevent 

complications and adverse effects. ACIP 

recommendations (February 8, 2002) 

state, ‘‘contraindications and 

precautions to vaccination dictate 

circumstances when vaccines must not 

be administered. The majority of 

contraindications and precautions are 

temporary, and the vaccination can be 

administered later. For example, 

persons with acute febrile conditions 

should not be immunized until their 

fever subsides. A medical 

contraindication is a condition in a 

recipient that increases the risk for a 

serious adverse reaction. For example, 

administering influenza vaccine to a 

person with an anaphylactic allergy to 

egg protein could cause serious illness 

in or death of the recipient.’’ The ACIP 

recommendations further state that one 

universal contraindication applicable to 

all vaccines is a history of a severe 

allergic reaction after a prior dose of 

vaccine or vaccine constituent.

If immunization is medically 

contraindicated, ACIP recommendations 

(2002) state that prophylactic use of 

antiviral agents is an option for 

preventing influenza among these 

persons. Persons who have a history of 

anaphylactic hypersensitivity to vaccine 

components but who are also at high 

risk for complications from influenza 

can benefit from the vaccine after 

appropriate allergy evaluation and 

desensitization. The report on the ‘‘Use 

of Standing Orders Programs to Increase 

Adult Vaccination Rates,’’ in the March 

24, 2000 MMWR, states that standing 

orders protocols should also specify that 

vaccines be administered by healthcare 

professionals trained to (a) screen 

patients for contraindications to 

vaccination, (b) administer vaccines, 

and (c) monitor patients for adverse 

events, in accordance with State and 

local regulations. 

It is important for facilities to 

remember that residents have the right 

to refuse immunization. However, 

educating residents and family members 

regarding the benefits of receiving 

immunizations generally results in 

consent. 

III. 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.


EP15AU05.021</GPH>
Federal Register / Vol. 70, No. 156 / Monday, August 15, 2005 / Proposed Rules 47765

• 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 are soliciting public comment on 

each of these issues for the following 

sections of this document that contain 

information collection requirements: 

This proposed rule requires facilities 

to develop protocols or policies and 

procedures. As a facility develops and 

implements immunization protocols or 

procedures, we expect that obtaining 

previous immunization history on each 

resident, when possible, would be a part 

of the process. Additionally, we expect 

the facility to document in the resident’s 

medical record information concerning 

immunization history, contraindications 

etc. as a part of the process of 

immunizing residents. For example, the 

facility must indicate in the resident’s 

medical record that the resident had 

received an influenza immunization, or 

that the vaccination was medically 

contraindicated, or that the 

immunization was refused. If the 

immunization was refused, 

documentation must include that the 

resident or the resident’s legal 

representative received appropriate 

education and consultation regarding 

the benefits of influenza immunization. 

The initial burden associated with 

these requirements in the first year, 

would be related to the establishment of 

policies and protocols for 

implementation of the immunization 

rule. This would be approximately 5 

hours of a registered nurse’s time per 

facility i.e. 80,695 hours for the first year 

(5 hours × 16,139 facilities). In 

subsequent years, we estimate that the 

burden associated with documentation 

of the immunization status of the 

resident in the medical records would 

be approximately 5 minutes of the 

registered nurse’s time, which would be 

134,492 hours per year (5 minutes per 

resident × 100 residents per facility ×

16,139 facilities. 

If you comment on these information 

collection and recordkeeping 

requirements, please mail copies 

directly to the following:

Centers for Medicare & Medicaid 

Services, Office of Strategic 

Operations and Regulatory Affairs, 

Regulations Development Group, 

Attn: Jim Wickliffe, CMS–3198–P, 

Room C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–

1850; and 

Office of Information and Regulatory 

Affairs, Office of Management and 

Budget, Room 10235, New Executive 

Office Building, Washington, DC 

20503, Attn: Christopher Martin, CMS 

Desk Officer, CMS–3198–P, 

Christopher Martin@omb.eop.gov. Fax 

(202) 395–6974. 

IV. Response to Comments

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

V. Waiver of the 60-day Comment 

Period 

We ordinarily publish a notice of 

proposed rulemaking in the Federal 

Register and invite public comment on 

the proposed rule. The notice of 

proposed rulemaking includes a 

reference to the legal authority under 

which the rule is proposed, and the 

terms and substance of the proposed 

rule or a description of the subjects and 

issues involved. In accordance with 

section 1871(b)(1) of the Act, we 

routinely allow a comment period of at 

least 60 days on proposed rules that 

affect the Medicare program. This 

procedure can be waived; however, if an 

agency finds good cause that a 60-day 

comment period is impracticable, 

unnecessary, or contrary to the public 

interest, and incorporates a statement of 

the finding and its reasons in the rule 

issued. In accordance with section 

1871(b)(2)(C) of the Act, we have 

shortened the comment period for this 

proposed rule from 60 to 15 days to 

allow us to hopefully finalize these 

provisions by October 1, 2005 in time 

for the 2005–2006 flu season. It is our 

view that a 60 day delay in receiving 

public comments on this proposed rule 

and publishing the subsequent final rule 

will be extremely detrimental to the 

health of nursing home residents, as 

epidemics of influenza typically occur 

during the winter months and are 

responsible for an average of 

approximately 20,000 to 40,000 deaths 

per year in the United States. Influenza 

viruses also can cause pandemics, 

during which rates of illness and death 

from influenza-related complications 

can increase dramatically. Rates of 

infection are highest among children, 

but rates of serious illness and death are 

highest among persons 65 and older and 

persons of any age who have medical 

conditions that place them at increased 

risk for complications from influenza 

and pneumonia. Vaccines are the most 

effective means to protect against many 

complications related to influenza and 

pneumonia. The ACIP 

recommendations for 2004 to 2005, to 

decrease the risk of influenza, state that 

the optimal time for influenza 

vaccinations is October through 

November. If this proposed rule is 

published with a 60-day comment 

period it is highly unlikely that a final 

rule can be issued before October, and 

even if that were possible, nursing 

facilities would not have the lead time 

necessary to obtain resident and/or 

family consent. If expedited and 

published with a 15-day comment 

period, this delay can be prevented and 

the rule can be effective in the 2005–

2006 flu season, with the potential of 

saving many lives. 

We anticipate that the affect of this 

rule will be to increase immunization 

rates in nursing homes to 90 percent, 

which is the Healthy People 2010 goal. 

This will enable about half a million 

frail elderly individuals who are not 

currently immunized to be immunized. 

The CMS/CDC standing orders project 

in 2003 found that in nursing home 

residents, influenza vaccine is 

associated with a 27–35 percent 

reduction in mortality, and a 44–52 

percent reduction in all-cause 

hospitalizations. Similarly, 

pneumococcal vaccination is associated 

with a 20–26 percent reduction in 

mortality, and a 12–28 percent 

reduction in all-cause hospitalization. 

We recognize that these associations are 

not necessarily causal because the data 

are cross-sectional with no correction 

for confounding variables. However, the 

findings are consistent with findings 

regarding immunization in the general 

population. Therefore, it is imperative 

that this proposed rule is published 

with a 15-day comment period so that 

a final rule can be published and 

effective in the 2005–2006 flu season. 

Even though pneumococcal vaccines 

can be administered throughout the 

year, the percentage of patients and 

residents immunized remains low. 

Therefore, this proposed rule would be 

a vehicle to improve immunization rates 

and would be consistent with the 

Healthy People 2010 objectives. 

We believe that a continued delay in 

implementation of this rule would 

greatly hinder increased immunization 

of residents in LTC facilities before the 

onset of this year’s influenza season. We 

conclude that, in this instance, a 60-day 

comment period is unnecessary and 

contrary to public interest. We find on 

this basis, that there is good cause for 

waiving the 60-day comment period 

under section 1871(b)(2)(C) of the Act.

47766 Federal Register / Vol. 70, No. 156 / Monday, August 15, 2005 / Proposed Rules 

VI. Regulatory Impact

(If you choose to comment on issues in this 

section, please include the caption ‘‘Impact 

Analysis’’ at the beginning of your comment.)

A. Overall Impact 

We have examined the impacts of this 

rulemaking as required by Executive 

Order 12866 (September 1993, 

Regulatory Planning and Review), the 

Regulatory Flexibility Act (RFA) 

(September 19, 1980, Pub. L. 96–354), 

section 1102(b) of the Social Security 

Act, Executive Order 13132 (August 4, 

1999, Federalism), the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4), and the Congressional Review 

Act (5 U.S.C. 804(2)). 

Executive Order 12866 directs 

agencies to issue regulations only after 

consideration of 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). 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 is an 

economically ‘‘significant regulatory 

action’’ as defined by section 3(f) of 

Executive Order 12866, and a ‘‘major 

rule’’ as defined in the Congressional 

Review Act. We have reached this 

conclusion because of the substantial 

life-saving effects of the rule and its 

anticipated reduction in the medical 

costs associated with influenza and 

pneumonia. We believe that there are no 

significant costs associated with this 

proposed rule. It would not impose any 

mandates on State, local, or tribal 

governments, or the private sector that 

would result in an expenditure of $100 

million in any given year. Since most 

program participants comply with the 

statutory and regulatory requirements 

making unnecessary the imposition of 

termination from Medicare, Medicaid 

and, where applicable, other Federal 

health care programs, and since 

Medicare generally pays the cost of the 

vaccines that are the subject of this rule 

we do not anticipate more than a 

minimal economic impact on nursing 

facilities as a result of this proposed 

rule. There is a cost to the Medicare 

program for the vaccines to the extent 

that they are provided to Medicare 

beneficiaries, as discussed below. 

As previously discussed in this 

preamble, this proposed rule would 

have a substantial life-saving effect. We 

have developed estimates of these lifesaving effects, along with estimated 

changes in medical care costs, and 

present these estimates and the 

assumptions on which they are based in 

the discussion and table that follows. 

Influenza 

Assumptions (Benefit) 

There are approximately 2 million 

residents in LTC facilities. Sixty-five 

percent had documentation stating they 

received influenza immunization per 

the 1999 National Nursing Home 

Survey, National Center for Health 

Statistics, CDC. An October, 2000 article 

in the Journal of American Geriatric 

Society ‘‘Influenza outbreak detection 

and control measures in nursing homes 

in the United States (Zadeh MM, Buxton 

Bridges C, Thompson WW, Arden NH, 

Fukuda K.)’’ indicated that 83 percent of 

LTC residents in the study received 

immunizations. The midpoint between 

the two reports is 74 percent. The 

projected immunization rate after 

regulation implementation is 90 

percent. 

The 2005 influenza vaccination 

administration reimbursement rate is 

$18 (unweighted average of Medicare 

‘‘National Flu Biller Administration 

Codes’’). The 2005 Influenza vaccine 

reimbursement rate is $10.10 (Medicare 

rate; 95 percent of Average Wholesale 

Price (AWP). There is a wide variation 

in the influenza rate year to year, due to 

the prevalent strains of influenza virus 

each influenza season and the degree to 

which the vaccine matches prevalent 

strains as well as other factors. 

Effectiveness of Influenza vaccine for 

preventing influenza illness is 30–40 

percent according to ACIP (Harper SA, 

Fukuda K, Uyeki TM, Cox NJ, Bridges 

CB; Prevention and control of influenza: 

recommendations of the ACIP. MMWR 

Recomm Rep. 2004 May 28; 53(RR–6):1–

40). 

As stated above, the rate of 

hospitalization for the LTC population 

among those ill with influenza is 25 

percent (Arden NH, et al.). The 

influenza vaccine is 50–60 percent 

effective in preventing hospitalization 

due to influenza in the LTC population 

(ACIP, May 2004).

According to (Arden NH, et al.) the 

case-fatality for influenza disease in the 

LTC population is 10 percent of the 

number of residents who become ill 

with influenza. The influenza vaccine is 

80 percent effective in preventing death 

in LTC residents with influenza illness 

(ACIP, May 2004). The average 

Medicare cost per hospital discharge for 

influenza is $8,500 per the Office of the 

Actuary, CMS (including medical 

education, disproportionate share and 

other pass through). The data on the 

influenza related hospitalization of SNF 

residents is not available. SNF residents 

are short term stay therefore we do not 

think those numbers are sufficiently 

large to have a great impact on the 

overall Medicare costs.

TABLE 1.—ESTIMATED FEDERAL BENEFITS DUE TO INCREASED RATE OF INFLUENZA IMMUNIZATIONS

LTC Residents Current Projected Difference 

% who receive influenza immunization ......................................................................... 74% 90% 16% 

Number who receive influenza immunization ................................................................ 1,480,000 1,800,000 320,000 

Number ill with influenza ............................................................................................... 133,380 123,300 (10,080) 

Number hospitalized due to influenza ........................................................................... 20,358 15,030 (5,328) 

Number who die from influenza complications ............................................................. 7,344 5,040 (2,304) 

Direct Medicare cost of inpatient hospital treatment ..................................................... $173,043,000 $127,755,000 ($45,288,000) 

Assumptions (Cost) 

Influenza vaccine must be 

administered annually: however, 

virtually all influenza vaccinations 

administered in LTC facilities are 

covered under the Medicare Part B 

program. The cost to Medicare for 

provision of the influenza vaccinations 

is equal to the cost of the vaccines plus 

administration costs. In addition to 

these direct Medicare costs, an indirect 

Federal cost would be incurred from 

reduced savings in the Medicaid 

program. For every hospitalization of a 

LTC facility resident, Medicaid saves 

$1,000 for nursing home care not 

provided while the resident is in the 

hospital. The weighted average of the 

Federal contribution to Medicaid is 57 

percent (Office of the Actuary, CMS), 

and Medicaid is a primary source of 

payment for 40 to 59 percent of LTC 

facility residents (1999 National Nursing

Federal Register / Vol. 70, No. 156 / Monday, August 15, 2005 / Proposed Rules 47767

Home Survey) and with a mid point of 

50 percent. The total federal cost related 

to the increased influenza 

immunizations is the total of the direct 

Medicare costs combined with the lost 

savings to Medicaid.

TABLE 2.—ESTIMATED FEDERAL IMPACT OF INCREASED INFLUENZA IMMUNIZATION ON MEDICARE AND MEDICAID

Current ($) Projected ($) Difference 

Total Medicare reimbursement for cost of influenza vaccine and administration (320,000 ×

$28.10) ....................................................................................................................................... 41,588,000 50,580,000 $8,992,000 

Federal share of Medicaid LTC facility savings due to resident hospital stays.* ......................... (5,802,030) (4,283,550) $1,518,480 

Total Federal Costs ................................................................................................................ 35,785,970 46,296,450 $10,510,480 

* (Number of residents hospitalized) × ($1000 cost for NH facility per hospitalization) × (57% Federal portion of Medicaid payments) × (50% 

portion of all NH patients paid by Medicaid) 

TABLE 3.—NET FEDERAL SAVINGS

DUE TO INCREASED INFLUENZA IMMUNIZATION

Estimated Federal Savings 

(from Table 1) ................... ($45,288,000) 

Estimated Federal Costs 

(from Table 2) ................... $10,510,480 

Total Net Federal Savings ............................ ($34,777,520) 

Lives saved per year ............ 2,304 

In other rules, we have used an 

average value of a statistical life of $5 

million to monetize the decreased 

mortality benefits of the rule. The 

population affected by this rule has 

different demographic and other 

characteristics from the populations that 

were addressed in these other rules. 

However, due to the lack of data on this 

specific population and in order to be 

consistent with previous rules, we are 

assuming a value of $5 million for the 

average value of a statistical life for this 

rule. 

Therefore, since we estimate 2,304 

lives will be saved by the influenza 

vaccination, we estimate the value 

saved from saving these lives as $11.52 

billion. 

Invasive Pneumococcal Disease 

Assumptions (Benefit) 

There are approximately 2 million 

residents in LTC facilities. The 

projected immunization rate after 

regulation implementation is 90 

percent. The LTC resident vaccination 

rate is estimated between 39 percent 

(1999 National Nursing Home Survey 

(NNHS)) and 56 percent (community 

rate, 2003 National Health Interview 

Survey). Virtually all residents with 

invasive disease are hospitalized. The 

rate of pneumococcal invasive disease 

in unvaccinated persons aged greater 

than or equal to 65 equals 52–85/100 

000, (ACIP, 1997). The case fatality ratio 

of invasive pneumococcal disease in 

persons aged greater than or equal to 65 

(despite appropriate medical treatment) 

is 30–40 percent. The average cost per 

hospital discharge for invasive 

pneumococcal disease is $8500 

(Including medical education, 

disproportionate share and other pass 

through) (Office of the Actuary, CMS). 

According to CDC recommendations, 

usually one dose of the pneumococcal 

polysaccharide vaccine (PPV) is all that 

is needed, for a person only needs to be 

immunized once in a life time. 

However, in some situations a second 

dose is recommended for people 65 and 

older. Therefore, expense related to this 

rule is projected to cost more at the 

beginning period of implementation. 

The 45 percent documented 

immunization rate in the table below 

represents data obtained in the year 

1999, and since then the rate may have 

increased. Implementing the influenza 

immunization process is more 

challenging than implementing the 

similar PPV immunization process. 

Pneumococcal immunizations can be 

given all through the year without time 

constraints and the vaccine supplies 

have not been an issue. We anticipate 

that implementation of this rule would 

result in increase in immunization rate 

and documentation of the related data 

for future comparison. The table below 

is relating the years 1–5 to the current 

data.

Invasive Pneumococcal Disease 

Assumptions (Benefit)

TABLE 4.—ESTIMATED FEDERAL BENEFITS DUE TO INCREASED RATE OF PNEUMOCOCCAL IMMUNIZATIONS

LTC Residents Current year 

Projected 

Year 1 Year 2 Year 3 Year 4 Year 5 

Percent who receive pneumococcal immunization 45% 70% 75% 80% 85% 90% 

Number who receive pneumococcal immunization 

per year .............................................................. 500,000 100,000 100,000 100,000 100,000 

Cumulative number immunized (since inception of 

Medicare pneumococcal immunization benefits) 900,000 1,400,000 1,500,000 1,600,000 1,700,000 1,800,000 

Number who develop invasive pneumococcal disease .................................................................... 970 742 697 651 606 560 

Deaths from invasive pneumococcal disease (or complications related to the disease)

Benchmark—number deaths without increased 

immunizations ..................................................... 340 340 340 340 340 340 

Number deaths following implementation of immunization regulation ......................................... 260 244 228 212 196 

Number lives saved due to pneumococcal immunization ............................................................... .................... 80 96 112 128 144 

47768 Federal Register / Vol. 70, No. 156 / Monday, August 15, 2005 / Proposed Rules 

TABLE 4.—ESTIMATED FEDERAL BENEFITS DUE TO INCREASED RATE OF PNEUMOCOCCAL IMMUNIZATIONS—Continued

LTC Residents Current year 

Projected 

Year 1 Year 2 Year 3 Year 4 Year 5 

Direct Federal costs for treatment of invasive pneumococcal disease

Benchmark—costs without increased immunizations .................................................................... $8,246,190 $8,246,190 $8,246,190 $8,246,190 $8,246,190 $8,246,190 

Costs following implementation of immunization 

regulation ............................................................ .................... $6,310,740 $5,923,650 $5,536,650 $5,149,470 $4,762,380 

Savings following implementation of increased 

pneumococcal immunizations ............................ .................... ($1,935,450) ($2,322,540) ($2,709,540) ($3,096,720) ($3,483,810) 

Assumptions (Cost) 

The 2005 pneumococcal vaccination 

administration reimbursement rate is 

$18 (unweighted average of Medicare 

‘‘National Flu Biller Administration 

Codes’’) and the pneumococcal vaccine 

reimbursement rate is $23.28 (Medicare 

rate; 95% of AWP). The pneumococcal 

vaccine is generally administered once 

per beneficiary lifetime. Therefore this 

is not a recurring cost, but would cost 

more up front to give lifetime immunity 

to residents (for the cost estimate, we 

assumed 500,000 people would receive 

the vaccine in the first year and 100,000 

people each would receive the vaccine 

in years two through five). The reason 

we assume the higher number the first 

year is because we expect all the eligible 

residents in the facilities in the first year 

would receive the pneumococcal 

vaccine. In the following years only the 

new residents who are eligible would 

need the immunization. Virtually all 

pneumococcal immunizations 

administered in LTC facilities are 

covered under the Medicare Part B 

program. For every hospitalization 

concerning Medicaid beneficiaries, 

Medicaid saves $1000 for nursing home 

care not provided while the resident is 

in the hospital. The weighted average of 

the Federal contribution to Medicaid is 

57 percent (Office of the Actuary, CMS). 

Medicaid is a primary source of 

payment for 40 to 59 percent in LTC 

(1999 National Nursing Home Survey) 

and the mid point is 50 percent. The 

total Federal cost related to the 

increased pneumococcal immunizations 

is the total of the direct Medicare 

reimbursement costs combined with the 

lost savings to Medicaid.

TABLE 5.—FEDERAL IMPACT OF INCREASED PNEUMOCOCCAL IMMUNIZATION ON MEDICARE AND MEDICAID

Current year 

($) 

Projected ($) 

Year 1 Year 2 Year 3 Year 4 Year 5 

Medicare reimbursement for cost of pneumococcal vaccine and administration

Annual Medicare cost following increased pneumococcal immunization* ................................... ...................... 20,640,000 4,128,000 4,128,000 4,128,00 4,128,000 

Cumulative Medicare cost (since inception of 

Medicare pneumococcal immunization benefits) .................................................................... 37,152,000 57,792,000 61,920,000 66,048,000 70,176,000 74,304,000 

Federal share of Medicaid LTC facility savings due to resident hospital stays

Federal savings per year without increased 

immunizations** ................................................ (276,490) (276,490) (276,490) (276,490) (276,490) (276,490) 

Federal savings per year following increased 

pneumococcal immunization** ......................... ...................... (211,595) (198,617) (185,638) (172,659) (159,680) 

Lost Federal savings due to increased 

pneumococcal immunization ..................... ...................... 64,895 77,874 90,852 103,831 116,810 

Total Federal Costs (annual Medicare costs 

+ lost Federal savings) ............................. Not 

Available 

20,704,895 4,205,874 4,218,852 4,231,831 4,244,810 

* Year 1 (500,000 × $41.28); Years 2–5 (100,000 × $41.28). 

** (Number of residents hospitalized) × ($1000 cost for NH facility per hospitalization) × (57% Federal portion of Medicaid payments) × (50% 

portion of all NH patients paid by Medicaid). 

TABLE 6.—NET FEDERAL COSTS DUE TO INCREASED PNEUMOCOCCAL IMMUNIZATION

Year 1

Estimated Federal Savings (from Table 4) ....................................................................................................................................... ($1,935,450) 

Estimated Federal Costs (from Table 5) ........................................................................................................................................... 20,704,895 

Total Net Federal Cost in Year 1 ...................................................................................................................................................... 18,769,445 

Federal Register / Vol. 70, No. 156 / Monday, August 15, 2005 / Proposed Rules 47769

TABLE 6.—NET FEDERAL COSTS DUE TO INCREASED PNEUMOCOCCAL IMMUNIZATION—Continued

Years 2–5

Estimated Federal savings (from table 4) + Estimated Federal costs (from table 5) 

Total Net Federal Cost in Year 2 ($2,322,540) + 4,205,874 ............................................................................................................ $1,883,334 

Total Net Federal Cost in Year 3 ($2,709,540) + 4,218,852 ............................................................................................................ 1,509,312 

Total Net Federal Cost in Year 4 ($3,096,720) + 4,231,831 ............................................................................................................ 1,135,111 

Total Net Federal Cost in Year 5 ($3,483,810) + 4,244,810 ............................................................................................................ 761,000 

Total Net Federal Cost Years 1–5 ............................................................................................................................................. 24,058,202 

Lives saved Years 1–5 ............................................................................................................................................................... 560 

Using the same $5 million per life 

value of a statistical life as before and 

since we estimate 560 lives will be 

saved by the pneumococcal vaccination, 

we estimate the value saved from saving 

these lives as $2.8 billion.

For the purpose of this analysis we 

have considered the protective effects of 

influenza and pneumococcal 

immunization individually. However, 

the combined effect of both 

immunizations is additive in preventing 

hospitalization and deaths. The July 30, 

1999 article in the journal ‘‘Vaccine’’

titled ‘‘The additive benefits of 

pneumococcal vaccinations during 

influenza seasons among elderly 

persons with chronic lung disease’’

reports that both vaccinations together 

demonstrated additive benefit as there 

was a 65 percent reduction in 

hospitalization for pneumonia and 81 

percent reduction in death versus the 

situation when neither had been 

received. Also excluded in this analysis 

is the increased protection against 

influenza infection afforded by the 

‘‘herd’’ effect after 80 to 90 percent of 

residents are immunized against 

influenza. The 2003, CMS/CDC standing 

orders project report states that a 

facility-level influenza vaccination of 80 

percent and more of residents may be 

independently associated with reduced 

patient hospitalization and death. 

Further, the cost-saving effects of this 

rule, and the costs of the vaccine doses 

themselves, are respectively benefits 

and costs to the taxpayer. Since 

Medicare pays virtually all medical, 

hospital, and (starting in 2006) drug 

costs for this population, the expected 

savings from reduced hospitalizations 

would largely accrue to the Federal 

budget. 

In order to comply with this rule, 

facilities will develop the necessary 

policies and procedures which will be 

followed by staff as a standard practice. 

We estimate the time and cost related to 

this process in the following tables:

POLICY AND PROCEDURE IMPLEMENTATION RELATED TO THE IMMUNIZATION RULE

[This is only a one time expense for the facilities] 

No. of LTC facilities Hours spent per facility Total burden hours Total cost per agency 

16,139 .......... 5 hours first year only ............................................................... 80,695 hours only first year .... 80,695 hours × $23.70 * = 

$1,912,471. 

* $23.70 is the average salary of a registered nurse as per U.S. Department of Labor (http://www.bls.gov/oes/current/oes291111.htm#nat). 

This rule proposes that the resident’s 

immunization status be documented in 

the resident’s medical record therefore, 

the following table presents the 

estimated time and cost related to the 

implementation of this process.

DOCUMENTATION TIME FOR BOTH IMMUNIZATIONS

[These expenses are annual] 

No. of LTC facilities Hours spent per resident per facility Total burden hours Total cost per agency 

16,139 .......... 16,139 × 100 ** residents × 5 minutes = 8,069,500 minutes 

134,492 hours.

134,492 hours ......................... 134,492 hours × $23.70 * = 

$3,187,460. 

* $23.70 is the average salary of a registered nurse as per U.S. Department of Labor (http://www.bls.gov/oes/current/oes291111.htm#nat). 

** 100 is the average number of residents in each facility. 

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 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 small businesses, 

nonprofit organizations, and small 

government jurisdictions. Most nursing 

facilities are small entities, either by 

nonprofit status or by having revenues 

of $11.5 million or less annually (the 

applicable size standard of the Small 

Business Administration). Individuals 

and States are not included in the 

definition of a small entity, and other 

medical care providers are not affected 

by this proposed rule except indirectly, 

through reduced utilization of care by 

individuals who do not, but would 

otherwise, require hospitalization. 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 section 604 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

47770 Federal Register / Vol. 70, No. 156 / Monday, August 15, 2005 / Proposed Rules 

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. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 also 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule whose mandates may result in 

expenditure in any 1 year by State, 

local, or tribal governments, in the 

aggregate, or by the private sector, of 

$100 million in 1995 dollars. This 

proposed rule would impose no 

mandates on State, local, or tribal 

governments. As indicated elsewhere in 

this analysis, costs mandated on nursing 

facilities, are minimal, and do not 

remotely approach this threshold. 

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, 

preempt State law, or otherwise 

implicate federalism. 

B. Anticipated Effects 

1. Effects on LTC facilities 

Based on the various studies and 

reports referenced earlier in the 

preamble, we expect that LTC facilities 

would benefit from the implementation 

of this proposed rule. The various 

studies discussed are evidence that 

prevention of influenza and pneumonia 

would lower the level of acuity, staff 

time and other expenses resulting in 

cost reductions. 

2. Effects on Beneficiaries 

The influenza vaccine is 50–60 

percent effective in preventing 

hospitalization due to influenza in the 

LTC population and increased 

immunizations are expected to improve 

health overall for the age group of 65 

years and older. As estimated above 

2,304 lives may be saved annually when 

residents receive influenza 

immunizations.

According to CDC’s Active Bacterial 

Core Surveillance for pneumococcal 

disease, approximately 5,700 deaths 

from invasive pneumococcal disease 

(bacteremia and meningitis) are 

estimated to have occurred in the 

United States in 2002. The October 1997 

Journal of the American Medical 

Association (JAMA) article ‘‘CostEffectiveness of Vaccination Against 

Pneumococcal Bacteremia Among 

Elderly People’’ indicated that 

vaccination of elderly people against 

pneumococcal bacteremia is one of the 

few interventions that have been found 

to both improve health and save 

medical costs. 

3. Effects on the Medicare and Medicaid 

Programs 

The reports from the January 2000, 

CMS’s Adult Immunization Project, 

indicates that ‘‘despite the fact that 

influenza and pneumococcal vaccines 

are clinically effective, cost-effective, 

and are Medicare Part B covered 

benefits, they remain underutilized.’’

Increased immunizations are expected 

to reduce the medical expenses and 

improve health overall for the age group 

of 65 years and older as reported in the 

Oct, 1997 JAMA article referenced 

earlier. As stated above, the rate of 

hospitalization for the LTC population 

among those ill with influenza is 25 

percent (Arden NH, et. al.). The average 

cost per hospital discharge for influenza 

is $8,500 per the Office of the Actuary, 

CMS. The influenza vaccine is 80 

percent effective in preventing death in 

the LTC population (ACIP, May 2004). 

As estimated above the net saving 

would be $34,777,520 and 2,304 lives 

saved when residents receive influenza 

immunizations. The net cost related to 

pneumococcal immunizations is 

estimated to be $ 18,821,360 the first 

year of implementation and $ 3,753,887 

in the following two to five years and 

143 lives saved. 

C. Alternatives Considered 

We considered other alternatives 

regarding immunizing residents. 

1. One alternative would be to keep 

the present rules, as they are written. 

The current regulations, however, have 

thus far not been effective at assisting us 

in increasing the rate of immunization 

of institutionalized residents to 90 

percent. Despite the Federal 

government’s unified efforts to increase 

the availability of safe and effective 

vaccines, and despite substantial 

progress in reducing many vaccinepreventable diseases, at-risk individuals 

are not receiving influenza and 

pneumococcal vaccines. Section 4107 of 

the Balanced Budget Act of 1997 

extended the influenza and 

pneumococcal immunization 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 

and pneumococcal immunizations was 

increased under this legislation, rates of 

immunization did not improve as 

anticipated. 

2. Another alternative would be to 

educate providers on the value of 

influenza and pneumococcal vaccines 

without rule making. However, as 

discussed in studies cited earlier in this 

rule, this has not been effective in 

improving immunization rates. 

D. Conclusion 

Increasing the utilization of costeffective preventive services is the goal 

of both CMS and CDC, and this 

proposed rule would facilitate the 

delivery of appropriate vaccinations in 

a timely manner, increase the levels of 

vaccination rate, and decrease the 

morbidity and mortality rate of 

influenza and pneumococcal diseases. 

As a result, the economic effects of the 

rule are substantial and overwhelmingly 

beneficial. In accordance with the 

provisions of Executive Order 12866, 

the Office of Management and Budget 

reviewed this proposed rule.

List of Subjects in 42 CFR Part 483 

Grant programs—health, Health 

facilities, Health professions, Health 

records, Medicaid, Medicare, Nursing 

homes, Nutrition, Reporting and 

recordkeeping requirements, Safety.

For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services amends 42 CFR 

chapter IV as set forth below:

PART 483—REQUIREMENTS FOR 

STATES AND LONG TERM CARE 

FACILITIES 

1. The authority citation for part 483 

continues to read as follows:

Authority: Secs. 1102 and 1871 of the 

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

1395hh).

Subpart B—Requirements for Long 

Term Care Facilities 

2. Section § 483.25 is amended by 

adding paragraph (n) to read as follows:

§ 483.25 Quality of care.

* * * * *

(n) Influenza and pneumococcal 

immunizations—(1) Influenza. The 

facility must ensure that—

(i) Each resident is offered an 

influenza immunization between 

October 1 through March 31 annually, 

unless the immunization is medically 

contraindicated or the resident has

Federal Register / Vol. 70, No. 156 / Monday, August 15, 2005 / Proposed Rules 47771

already been immunized during this 

time period; and 

(ii) The resident or the resident’s legal 

representative must be provided the 

opportunity to refuse immunization. If 

the resident or the resident’s legal 

representative refuses immunization, 

the facility must ensure the resident or 

the resident’s legal representative 

receives appropriate education and 

consultation regarding the benefits of 

influenza immunization. 

(iii) The resident’s immunization 

status is documented in the resident’s 

medical record, including but not 

limited to; that the resident received an 

influenza immunization, or 

immunization was medically 

contraindicated, or immunization was 

refused. If the immunization was 

refused, documentation must include 

that the resident or the resident’s legal 

representative received appropriate 

education and consultation regarding 

the benefits of influenza immunization. 

(2) Pneumococcal disease. The facility 

must ensure that—

(i) Each resident is offered a 

pneumococcal immunization, unless 

the immunization is medically 

contraindicated or the resident has 

already been immunized; and 

(ii) The resident or the resident’s legal 

representative must be provided the 

opportunity to refuse immunization. If 

the resident or the resident’s legal 

representative refuses immunization, 

the facility must ensure the resident or 

the resident’s legal representative 

receives appropriate education and 

consultation regarding the benefits of 

pneumococcal immunization. 

(iii) The resident’s immunization 

status is documented in the resident’s 

medical record, including but not 

limited to; that the resident received 

pneumococcal immunization, or 

immunization was medically 

contraindicated, or immunization was 

refused. If the immunization was 

refused, documention must include that 

the resident or the resident’s legal 

representative received appropriate 

education and consultation regarding 

the benefits of pneumococcal

immunization. 

(iv) Exception. As an alternative, 

based on an assessment and practitioner 

recommendation, a second 

pneumococcal shot may be given after 5 

years following the first pneumococcal 

immunization if the vaccine was 

administered before age 65, unless 

medically contraindicated or the 

resident or the resident’s legal 

representative refuses the second shot.

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program)

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program)

Dated: May 20, 2005. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services.

Approved: August 10, 2005. 

Michael O. Leavitt, 

Secretary.

[FR Doc. 05–16160 Filed 8–12–05; 8:45 am] 

BILLING CODE 4120–01–P

DEPARTMENT OF TRANSPORTATION

Maritime Administration 

46 CFR Part 389

[Docket No. MARAD–2005–22050] 

RIN 2133–AB67

Determination of Availability of 

Coastwise-Qualified Launch Barges

AGENCY: Maritime Administration, DOT.

ACTION: Notice of proposed rulemaking.

SUMMARY: The Maritime Administration 

(MARAD, we, our, or us) is publishing 

this proposed rulemaking to establish 

regulations governing administrative 

determinations of availability of 

coastwise-qualified launch barges to be 

used in the transportation and 

launching of offshore oil drilling or 

production platform jackets in specified 

projects. This rulemaking implements 

provisions of the Coast Guard and 

Maritime Transportation Act of 2004, 

which, among other things, requires the 

Secretary of Transportation (acting 

through the Maritime Administrator) to 

adopt procedures to determine if 

coastwise-qualified vessels are available 

for platform jacket transport and 

launching, and, if not, to allow the use 

of non-coastwise qualified foreign built 

vessels.

DATES: Comments are due by October 

14, 2005.

ADDRESSES: You may submit comments 

[identified by DOT DMS Docket Number 

MARAD–2005–22050] by any of the 

following methods: 

• Web Site: http://dms.dot.gov.

Follow the instructions for submitting 

comments on the DOT electronic docket 

site. 

• Mail: Docket Management Facility; 

U.S. Department of Transportation, 400 

7th St., SW., Nassif Building, Room PL–

401, Washington, DC 20590–001. 

• Hand Delivery: Room PL–401 on 

the plaza level of the Nassif Building, 

400 7th St., SW., Washington, DC, 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

• Federal eRulemaking Portal: Go to 

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

online instructions for submitting 

comments. 

Instructions: All submissions must 

include the agency name and docket 

number for this rulemaking. Note that 

all comments received will be posted 

without change to http://dms.dot.gov

including any personal information 

provided. Please see the Privacy Act 

heading under Regulatory Notices. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

dms.dot.gov at any time or to Room PL–

401 on the plaza level of the Nassif 

Building, 400 7th St., SW., Washington, 

DC, between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT:

Michael Hokana, Office of Ports and 

Domestic Shipping, Maritime 

Administration, MAR–830, Room 7201, 

400 7th St., SW., Washington, DC 

20590; telephone: (202) 366–0760; 

email: Michael.Hokana@dot.gov.

SUPPLEMENTARY INFORMATION: Section 27 

of the Merchant Marine Act of 1920, 

commonly known as the Jones Act (46 

App. U.S.C. 883), requires, with a few 

exceptions, that all cargo transported in 

the coastwise trade be carried on ships 

that are U.S.-owned and U.S.-built. The 

Jones Act has been amended over the 

years, and in 1988 a special technical 

proviso, known as the thirteenth 

proviso, was added to allow for the use 

of foreign-built platform jacket launch 

barges in the coastwise trade if no U.S.-

built vessels were found to be available. 

On August 9, 2004, the thirteenth 

proviso of the Jones Act was amended 

by section 417 of the Coast Guard and 

Maritime Transportation Act of 2004, 

Public Law 108–293 (the Act). Under 

the Act, the Secretary of Transportation 

is directed to establish procedures to 

issue determinations as to whether 

suitable U.S.-built barges are available 

for use in transportation and launching 

(i.e., installation) of offshore oil drilling 

or production structures. The Act 

directs that if the Secretary determines, 

upon application by the owner/operator 

of a foreign-built barge, that a suitable 

U.S.-built barge is not reasonably 

available for use in a specified launch 

project, then the foreign-built barge may 

be used. Because the Bureau of Customs 

and Border Protection (CBP) is 

responsible for enforcing violations of 

the coastwise laws, MARAD 

recommends that applicants that receive 

a determination from MARAD further