[Federal Register Volume 76, Number 86 (Wednesday, May 4, 2011)]
[Proposed Rules]
[Pages 25460-25477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-10646]
[[Page 25459]]
Vol. 76
Wednesday,
No. 86
May 4, 2011
Part III
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 482, 485, 491, et al.
Medicare & Medicaid Programs; Influenza Vaccination Standard for
Certain Participating Providers and Suppliers; Proposed Rule
Federal Register / Vol. 76 , No. 86 / Wednesday, May 4, 2011 /
Proposed Rules
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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.
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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
[[Page 25461]]
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 vaccine-preventable 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 influenza-related 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 vaccine- preventable diseases among
children, similar success has not been attained among adults (See Roush
SW, Murphy TV, ``Historical Comparisons of Morbidity and Mortality for
Vaccine-Preventable 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
[[Page 25463]]
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/health-center-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 high-risk 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 (Sec.
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
Sec. 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 Sec. 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
[[Page 25464]]
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 (Sec. 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 Sec. 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 Sec. 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 (Sec. 491.9)
We are proposing to add a new CfC standard for influenza
vaccination at Sec. 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.
[[Page 25465]]
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 (Sec.
494.30)
We are proposing to add a new CfC standard for influenza
vaccination at Sec. 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 (Sec.
482.42)
Proposed Sec. 482.42(c)(1) would require a hospital to develop and
implement policies and procedures regarding seasonal influenza and
pandemic influenza vaccination. Proposed Sec. 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 Sec.
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 Sec. 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 x 5 hours per hospital). The total
estimated annual cost associated with these requirements is $1,147,500
(25,500 hours x $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 x .05 hours per response). The total estimated annual cost
associated with these requirements is $45,000,000 (1,000,000 hours x
$45 per hour).
[[Page 25466]]
B. ICRs Regarding Condition of Participation: Provision of Services
(Sec. 485.635)
Proposed Sec. 485.635 states that CAHs must develop and implement
policies and procedures regarding seasonal influenza and pandemic
influenza vaccination. Proposed Sec. 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 Sec. 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 Sec. 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 x 5 hours per CAH). The total estimated annual
cost associated with these requirements is $292,500 (6,500 hours x $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 Sec. 482.4.
C. ICRs Regarding Provision of Services (Sec. 491.9)
Proposed Sec. 491.9 states that RHCs and FQHCs would have to
develop and implement policies and procedures regarding seasonal
influenza and pandemic influenza vaccination. Proposed Sec.
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 Sec. 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 Sec. 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 x 5
hours per facility). The total estimated annual cost associated with
these proposed requirements is $1,102,500 (24,500 hours x $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 x .05 hours per response). The total estimated annual cost
associated with these proposed requirements is $56,250,000 (1,250,000
hours x $45 per hour).
D. ICRs Regarding Condition: Infection Control (Sec. 494.30)
Proposed Sec. 494.30 states that ESRD facilities would have to
develop and implement policies and procedures regarding seasonal
influenza and pandemic influenza vaccination. Proposed Sec.
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 Sec. 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 Sec. 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 x 5 hours per
facility). The total estimated annual cost associated with these
proposed requirements is $1,215,000 (27,000 hours x $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 x .05 hours per response).
The estimated annual cost is $1,125,000 (25,000 hours x $45 per hour).
The total estimated annual cost associated with these proposed
requirements is approximately $106 million, as shown in Table 1.
[[Page 25467]]
Table 1--Estimated Annual Recordkeeping and Reporting Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Burden per Total annual Hourly labor Total labor Total capital/
Regulation section(s) OMB Control No. Respondents Responses response burden cost of cost of maintenance Total cost
(hours) (hours) reporting ($) reporting ($) costs ($) ($)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 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
Sec. 485.635(b)...................... 0938--New................. 1,300 1,300 5 6,500 ** 45 292,500 0 292,500
Sec. 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
Sec. 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]
----------------------------------------------------------------------------------------------------------------
Reduced
Gross treatment Net cost to
Primary payer vaccination costs to payers
cost 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
[[Page 25468]]
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 5,100
Rehabilitation Facilities).............................
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 20,000,000.
Rehabilitation Facilities) *.
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 500,000.
Facilities).
------------------------
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.
[[Page 25469]]
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
[[Page 25470]]
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 $327M
(millions).............................................
Less reduction in cost billed through other providers -$163.5M
and suppliers ** (millions)............................
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 non-emergency 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
[[Page 25471]]
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 middle-aged (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 non-institutionalized 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.
[[Page 25472]]
However, it is likely that about two-fifths 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 non-disabled 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 $330 million in costs
incurred by providers). These payments would be financed through the
same Federal and State shares as other Medicaid payments for these
services. Medicaid savings would be far lower, proportionally, than
Medicare costs because the incidence of hospitalization among younger
influenza patients is so much lower. We think it reasonable to assume
that hospitalization savings would roughly equal and quite possibly
exceed vaccine administration costs, so that the net effect of the rule
on Medicaid costs would be close to zero, or even cost-saving. We
emphasize that these are very rough estimates.
We have no better basis for estimating costs or savings to private
insurers. Overall, we think that they will pay about half of the costs
of the program. Because their enrollees are generally below age 65, and
if above such age have Medicare as primary insurance, their savings
from reduced medical care costs will reflect the far lower incidence of
influenza morbidity and mortality at younger ages, and the
correspondingly lower potential cost savings. Similar to our conclusion
for Medicaid, we think it reasonable to assume that savings to private
health plans would likely approximate the costs of the program, and
would in any event have a negligible effect on overall costs. Again, we
emphasize that these are very rough estimates.
Accordingly, as outlined in Table 10, all categories of payers
would at least break even in financial terms, and those that
disproportionately serve the oldest and sickest, notably Medicare,
would likely achieve substantial savings in relation to their costs.
Table 10--Distribution of Medical Costs and Savings
[$ In millions]
----------------------------------------------------------------------------------------------------------------
Reduced
Primary payer Gross treatment costs Net cost to
vaccination cost to payers 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
[[Page 25473]]
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 take-up
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
[[Page 25474]]
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]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
--------------------------------------
Category Primary estimate Low estimate High estimate Discount
Year rate Period
dollars (percent) covered *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized Qualitative (Unquantified) Thousands of lives saved Thousands of lives Thousands of lives 2011 7 2011-20
Value of Lives Saved among Patients but no precise estimate. saved but no precise saved but no precise
Immunized. estimate. estimate.
Thousands of lives saved Thousands of lives Thousands of lives 2011 3 2011-20
but no precise estimate. saved but no precise saved but no precise
estimate. estimate.
Annualized Value of Travel and $120.................... $60.................... $240................... 2011 7 2011-20
Convenience Savings to Patients
Immunized.
$120.................... $60.................... $240................... 2011 3 2011-20
Annualized Value of Reduced Medical $710.................... $355................... $1,420................. 2011 7 2011-20
Care Costs Incurred for Patients
Immunized.
$710.................... $355................... $1,420................. 2011 3 2011-20
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Monetized Costs to Medical $330.................... $165................... $660................... 2011 7 2011-20
Care Providers and Suppliers.
$330.................... $165................... $660................... 2011 3 2011-20
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized Payments to Medical Care ($380).................. ($190)................. ($760)................. 2011 7 2011-20
Providers and Suppliers by Federal
Government.
($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.
[[Page 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,
[[Page 25476]]
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 Sec. 482.42, a new paragraph (c) is added to read as
follows:
Sec. 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:
Sec. 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:
[[Page 25477]]
Sec. 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:
Sec. 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