1.This Act may be cited as
the Improving Dementia Care Treatment
for Older Adults Act of 2012
.
2.Congress makes the following
findings:
(1)More than
5,000,000 Americans are afflicted with Alzheimer's and related dementias, and
that number is projected to reach as much as 16,000,000 during the boomer’s
age wave
in the first half of the 21st century.
(2)Nearly 40 percent
of individuals with dementia living in nursing homes receive antipsychotic
drugs. No antipsychotics have been approved by the Food and Drug Administration
to treat dementia.
(3)The potential
harms of antipsychotics in frail elders are significant. Studies show that for
every 53 patients with dementia who are treated with such a pharmaceutical, one
will die. For every 9 to 25 patients that benefit from an antipsychotic, one
will die.
(4)A May 2011 report
issued by the Office of Inspector General of the Department of Health and Human
Services found that 305,000, or 14 percent, of the Nation’s 2,100,000 nursing
home residents had at least one claim for antipsychotics. The report documented
that 83 percent of Medicare claims for atypical antipsychotic drugs for elderly
nursing home residents were associated with off-label conditions, and that
antipsychotics are often prescribed to manage behavioral symptoms of patients
with dementia.
(5)In 2005 and 2008,
the Food and Drug Administration issued black box warnings
—the
strongest possible warning—stating that patients administered antipsychotics
face a risk of death 1.6 to 1.7 times greater than those who take a
placebo.
(6)Despite these
significant warnings, antipsychotic prescription rates in long-term care
facilities for patients with dementia and no diagnosis of psychosis are high.
In 1999, 39 percent of elderly nursing home residents with dementia and
aggressive behavioral symptoms received antipsychotics within a one-week
period. By 2006, the use of antipsychotics among nursing home residents with
dementia had increased by almost 1/3 to over
1/2 of these residents in some facilities. According to
the Department of Health and Human Services, the current national average
utilization rate of antipsychotics is 24 percent among long-stay
residents.
(7)The cost to
taxpayers associated with the overutilization of antipsychotics is high. Since
2007, the Federal government has collected more than $3,000,000,000 in
settlements for illegal off-label marketing of antipsychotics. In a June 2011
lawsuit, a Circuit Court Judge fined a company $327,000,000 for deceptive
marketing of an antipsychotic, and concluded that the company displayed
a callous disregard to a patient’s right to have all information
available
.
(8)In late 2011, the
Chief Medical Officer of the Centers for Medicare & Medicaid Services
testified before the Special Committee on Aging of the Senate that 75 percent
of Americans who are diagnosed with Alzheimer’s will be admitted to a nursing
home by age 80.
(9)Leading medical
experts and organizations advise that individuals with dementia who display
agitation and disruptive behaviors are often trying to communicate, and their
failure to be able to do so can result in frustration and acting
out
. The resulting agitation and disruptive behaviors may signify unmet
needs or symptoms, including pain, constipation, negative responses to noise,
or interaction with other individuals.
(10)The American
Medical Directors Association advises practitioners to address the underlying
causes and factors contributing to behavioral symptoms through a
detailed review of a patient’s symptom history and a careful assessment
of the circumstances in which problematic behavior occurs as a basis for both
medication treatment and non-pharmacological interventions.
(11)LeadingAge
advises that family members and professional caretakers ought to try
first to understand what the patient is trying to convey. Then, they can take
appropriate action.
LeadingAge also notes that there is a
growing body of evidence that supports the effectiveness of behavioral
modifications and non-pharmacological interventions to manage
dementia.
(12)In May 2012, the
Centers for Medicare & Medicaid Services set a goal of reducing the
utilization of antipsychotics in long-term care facilities by 15 percent by the
end of the year. The Partnership to Improve Dementia Care is a collaborative
effort with industry and advocacy partners to improve training in nursing homes
and to further develop appropriate alternatives to antipsychotics for nursing
homes to use in providing care to residents who do not have a specific clinical
indication for the use of those agents.
3.Prescriber
education programs
(a)Section 1817(k) of the Social Security Act (42 U.S.C.
1395i(k)) is amended by adding at the end the new paragraph:
(9)Prescriber
education programs
(A)
(i)The
Managing Trustee shall transfer to the Trust Fund, under rules similar to the
rules described in paragraph (2)(C), an amount equal to the penalties and
damages obtained and otherwise creditable to miscellaneous receipts of the
general fund of the Treasury obtained under sections 3729 through 3733 of title
31, United States Code (known as the False Claims Act), in cases involving
claims related to the off-label marketing of any prescription drug (other than
funds awarded to a relator, for restitution, or otherwise authorized by
law).
(ii)Appropriated
amounts to account for prescriber education programsThere are
hereby appropriated to the Account from the Trust Fund some portion of such
amounts transferred to the Trust Fund under clause (i), to be available without
further appropriation until expended, for purposes of carrying out prescriber
education programs and other activities in accordance with this
paragraph.
(B)Prescriber
education programs
(i)The Secretary, acting through the Centers for Medicare
and Medicaid Services, in consultation with the Director of the Agency for
Healthcare Research and Quality and the Commissioner of Food and Drugs, shall
establish and implement prescriber education programs.
(ii)The
Secretary shall establish and begin implementation of prescriber education
programs under this paragraph by not later than 6 months after the date on
which funds are first made available to the Account under subparagraph
(A).
(C)In
this paragraph:
(i)Prescriber
education programsThe term prescriber education
program means a program to promote high quality evidence-based
treatment, including appropriate use of medications and non-pharmacologic
interventions, through the development and dissemination of objective,
educational, and informational materials to physicians and other prescribing
practitioners, including such a program developed by the Agency for Healthcare
Research and Quality.
(ii)The term off-label marketing means the
marketing of a prescription drug for an indication or use in a manner for which
the drug has not been approved by the Food and Drug
Administration.
.
(b)Section 1817(k)(2)(C)(iv) of the Social Security Act
(42 U.S.C. 1395i(k)(2)(C)(iv)) is amended by inserting , for the conduct
of prescriber education programs and other activities in accordance with
paragraph (9),
after restitution
.
4.Review and
reporting of antipsychotics prescribed to residents with dementia
(a)Skilled nursing
facilities
(1)Section 1819(b) of the Social Security Act (42 U.S.C.
1395i–3(b)) is amended by adding at the end the following new paragraph:
(9)Review and
reporting of antipsychotics prescribed to residents with dementia
(A)As part of the drug regimen review process under this
section (as described in section 483.60(c) of title 42, Code of Federal
Regulations), the pharmacist conducting such review with respect to a skilled
nursing facility shall—
(i)note any instance
where an antipsychotic was prescribed for a resident of the facility with
dementia for a use not approved by the Food and Drug Administration; and
(ii)submit to the
administrator, medical director, and director of nursing of the facility a
monthly report containing aggregate information regarding any instances noted
under clause (i) during the preceding month.
(B)A skilled nursing facility must—
(i)upon receipt of a
report submitted to the facility under subparagraph (A)(ii), submit such report
to the Secretary; and
(ii)make such
reports available to surveyors and the State Long-Term Care Ombudsman described
in section 712 of the Older Americans Act of
1965.
.
(b)Section 1919(b) of the Social Security Act (42 U.S.C.
1396r(b)) is amended by adding at the end the following new paragraph:
(9)Review and
reporting of antipsychotics prescribed to residents with dementia
(A)As part of the drug regimen review process under this
section (as described in section 483.60(c) of title 42, Code of Federal
Regulations), the pharmacist conducting such review with respect to a nursing
facility shall—
(i)note any instance
where an antipsychotic was prescribed for a resident of the facility with
dementia for a use not approved by the Food and Drug Administration; and
(ii)submit to the
administrator, medical director, and director of nursing of the facility a
monthly report containing aggregate information regarding any instances noted
under clause (i) during the preceding month.
(B)A nursing facility must—
(i)upon receipt of a
report submitted to the facility under subparagraph (A)(ii), submit such report
to the Secretary; and
(ii)make such
reports available to surveyors and the State Long-Term Care Ombudsman described
in section 712 of the Older Americans Act of
1965.
.
(c)The amendments made by this section shall take effect on the
date that is 1 year after the date of the enactment of this Act and apply to
reviews conducted with respect to drugs dispensed or administered on or after
such date.
5.Standardized
protocol for obtaining informed consent from an older adult with dementia prior
to prescribing an antipsychotic
(a)
(1)Skilled nursing
facilitiesSection 1819(b) of the Social Security Act (42 U.S.C.
1395i–3(b)), as amended by section 4, is amended by adding at the end the
following new paragraph:
(10)Standardized
protocol for obtaining informed consent from an older adult with dementia prior
to prescribing an antipsychotic for a use not approved by the food and drug
administration
(A)Not
later than 180 days after the date on which the Comptroller General submits the
report on State informed consent laws under section 5(a)(3) of the
Improving Dementia Care Treatment for Older
Adults Act of 2012, the Secretary shall develop a standardized
protocol for skilled nursing facilities to obtain informed consent from an
older adult with dementia (or, if applicable, the older adult’s designated
health care agent or other surrogate under State law or regulation) prior to
prescribing an antipsychotic to the older adult for a use not approved by the
Food and Drug Administration.
(B)The
standardized protocol developed under subparagraph (A) shall include the
following:
(i)A
requirement, with respect to an older adult with dementia, that—
(I)the facility,
with the involvement of the prescriber, inform the older adult (or, if
applicable, the older adult’s designated health care agent or other surrogate
under State law or regulation) of—
- (aa)possible side
effects and risks associated with the antipsychotic, including the mention of
any
black box warning
;
- (bb)treatment
modalities that were attempted prior to the use of the antipsychotic;
and
- (cc)any other
information the Secretary determines appropriate;
(II)the older adult
(or, if applicable, the older adult’s designated health care agent or other
surrogate under State law or regulation) provide consent to the administration
of the antipsychotic; and
(III)the
administration of the antipsychotic is in accordance with any plan of care that
the older adult has in place, including non-pharmacological interventions as
appropriate that can effectively address underlying medical and environmental
causes of behavioral disorders.
(ii)An alternative
protocol for obtaining such informed consent—
(I)in the case of
emergencies; and
(II)in the absence
of a clearly identified designated health care agent or other surrogate under
State law or regulation.
(iii)Other items
determined appropriate by the Secretary.
(C)Timing of
informed consentUnder the standardized protocol, a skilled
nursing facility shall obtain informed consent—
(i)prior to the
initial prescribing of antipsychotics; or
(ii)in the case of
an individual already prescribed antipsychotics when admitted to a facility,
the facility shall obtain informed consent if the facility maintains
antipsychotic treatment after the first drug regimen review conducted with
respect to the individual.
(D)Effective
beginning on the date that is 18 months after the date of enactment of the
Improving Dementia Care Treatment for Older
Adults Act of 2012, a skilled nursing facility shall comply with
the standardized protocol developed under subparagraph (A).
(E)Nothing in this paragraph shall preempt any provision
of State or Federal law that provides broader rights with respect to informed
consent for residents of
facilities.
.
(2)Section 1919(b) of the Social Security Act (42 U.S.C.
1396r(b)), as amended by section 4, is amended by adding at the end the
following new paragraph:
(10)Standardized
protocol for obtaining informed consent from an older adult with dementia prior
to prescribing an antipsychotic for a use not approved by the food and drug
administration
(A)Not
later than 180 days after the date on which the Comptroller General submits the
report on State informed consent laws under section 5(a)(3) of the
Improving Dementia Care Treatment for Older
Adults Act of 2012, the Secretary shall develop a standardized
protocol for nursing facilities to obtain informed consent from an older adult
with dementia (or, if applicable, the older adult’s designated health care
agent or other surrogate under State law or regulation) prior to prescribing an
antipsychotic to the older adult for a use not approved by the Food and Drug
Administration.
(B)The
standardized protocol developed under subparagraph (A) shall include the
following:
(i)A
requirement, with respect to an older adult with dementia, that—
(I)the facility,
with the involvement of the prescriber, inform the older adult (or, if
applicable, the older adult’s designated health care agent or other surrogate
under State law or regulation) of—
- (aa)possible side
effects and risks associated with the antipsychotic, including the mention of
any
black box warning
;
- (bb)treatment
modalities that were attempted prior to the use of the antipsychotic;
and
- (cc)any other
information the Secretary determines appropriate;
(II)the older adult
(or, if applicable, the older adult’s designated health care agent or other
surrogate under State law or regulation) provide consent to the administration
of the antipsychotic; and
(III)the
administration of the antipsychotic is in accordance with any plan of care that
the older adult has in place, including non-pharmacological interventions as
appropriate that can effectively address underlying medical and environmental
causes of behavioral disorders.
(ii)An alternative
protocol for obtaining such informed consent—
(I)in the case of
emergencies; and
(II)in the absence
of a clearly identified designated health care agent or other surrogate under
State law or regulation.
(iii)Other items
determined appropriate by the Secretary.
(C)Timing of
informed consentUnder the standardized protocol, a nursing
facility shall obtain informed consent—
(i)prior to the
initial prescribing of antipsychotics; or
(ii)in the case of
an individual already prescribed antipsychotics when admitted to a facility,
the facility shall obtain informed consent if the facility maintains
antipsychotic treatment after the first drug regimen review conducted with
respect to the individual.
(D)Effective
beginning on the date that is 18 months after the date of enactment of the
Improving Dementia Care Treatment for Older
Adults Act of 2012, a nursing facility shall comply with the
standardized protocol developed under subparagraph (A).
(E)Nothing in this paragraph shall preempt any
provision of State or Federal law that provides broader rights with respect to
informed consent for residents of
facilities.
.
(3)GAO study and
report on informed consent laws with respect to prescribing of an
antipsychotic
(A)The
Comptroller General of the United States (in this paragraph referred to as the
Comptroller General
) shall conduct a study of State laws and
regulations concerning informed consent with respect to the administration of
an antipsychotic (or other psychoactive medication) with regard to the
effectiveness of such laws and practices in changing the frequency of
prescribing of antipsychotics (or other psychoactive medications) to older
adults with dementia. The study shall include an analysis as to whether in the
case of States that have not enacted such informed consent laws, such States
have developed other mechanisms to guide appropriate prescribing of
antipsychotics in older adults with dementia.
(B)Not
later than 180 days after the date of enactment of this Act, the Comptroller
General shall submit to the Secretary and to Congress a report containing the
results of the study conducted under subparagraph (A), together with such
recommendations as the Comptroller General determines appropriate.
(b)Development of
measure of utilization of antipsychotics for inclusion on nursing home compare
website
(1)Section
1819(i) of the Social Security Act (42 U.S.C. 1395i–3(i)) is amended by adding
at the end the following new paragraph:
(3)Development of
measure of utilization of antipsychotics
(A)The Secretary shall include a measure of the utilization
of antipsychotics for each facility for inclusion on such website (or a
successor website) as part of the quality measures or health inspection
measures, or both such measures, under the Five-Star Quality Rating
System.
(B)In
developing the measure under subparagraph (A), the Secretary shall take into
account special patient populations, special care units, appropriate diagnoses,
and other factors, as determined appropriate by the
Secretary.
.
(2)Section
1919(i) of the Social Security Act (42 U.S.C. 1396r(i)) is amended by adding at
the end the following new paragraph:
(3)Development of
measure of utilization of antipsychotics
(A)The Secretary shall include a measure of the utilization
of antipsychotics for each facility for inclusion on such website (or a
successor website) as part of the quality measures or health inspection
measures, or both such measures, under the Five-Star Quality Rating
System.
(B)In
developing the measure under subparagraph (A), the Secretary shall take into
account special patient populations, special care units, appropriate diagnoses,
and other factors, as determined appropriate by the
Secretary.
.
6.GAO study and
report on standardized protocol for obtaining informed consent
(a)The Comptroller General of the United
States (in this section referred to as the Comptroller General
)
shall conduct a study to analyze the impact of the standardized protocol for
obtaining informed consent under sections 1819(b)(10) and 1919(b)(10) of the
Social Security Act, as added by paragraphs (1) and (2), respectively, of
section 5(a). Such study shall include an analysis of—
(1)whether changes in the utilization of
antipsychotics in selected facilities resulted in improved quality of life for
residents;
(2)whether changes in the utilization of
antipsychotics in selected facilities resulted in transfer of residents to
other settings for psychiatric care;
(3)whether selected facilities adopted greater
use of alternative treatment modalities, including non-pharmacologic
interventions and individualized, person-centered techniques;
(4)whether the standardized protocol resulted
in diminished access to antipsychotics among individuals with a diagnosis of
mental illness;
(5)whether the standardized protocol resulted
in physicians and other prescribers switching from prescribing antipsychotics
to prescribing other sedating psychoactive medications; and
(6)the prevalence of
antipsychotic prescribing for older adults outside of the skilled nursing
facility or nursing facility setting, including in hospitals and assisted
living communities.
(b)Not
later than 2 years after the compliance date under subparagraph (D) of each of
such sections 1819(b)(10) and 1919(b)(10), the Comptroller General shall submit
to the Secretary and to Congress a report containing the results of the study
conducted under subsection (a), together with such recommendations as the
Comptroller General determines appropriate.
7.IOM study and
report on use of antipsychotics across care settings
(a)
(1)The Secretary of
Health and Human Services (in this section referred to as the
Secretary
) shall seek to enter into an agreement with the
Institute of Medicine of the National Academies to conduct a study on—
(A)the appropriate prescribing of
antipsychotics for hospital inpatients; and
(B)whether documentation of antipsychotic use
in patients with dementia is provided during transitions of care from hospitals
to other care settings.
(2)Analysis of
patterns of useThe study
conducted under paragraph (1) shall include an analysis by the Institute of
Medicine of the patterns of use of antipsychotics in older adults with dementia
that originate in ambulatory settings.
(3)Under the agreement under paragraph (1),
the Institute of Medicine shall consult with leaders in the hospital and
medical care sector, the long-term care industry, the pharmacy community,
representatives of nursing home residents and family caregivers, leading
experts in psychiatry and geriatrics, and other entities or individuals
determined appropriate by the Secretary in conducting the study under the
preceding sentence.
(b)The
agreement entered into under subsection (a) shall provide for the Institute of
Medicine to submit to the Secretary and to Congress a report containing the
results of the study conducted under such subsection.