[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 3604 Introduced in Senate (IS)]
112th CONGRESS
2d Session
S. 3604
To amend title XVIII of the Social Security Act to provide for the
implementation of prescriber education programs and to establish
requirements relating to the administration of antipsychotics to
residents of skilled nursing facilities and nursing facilities under
the Medicare and Medicaid programs, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
September 20, 2012
Mr. Kohl (for himself, Mr. Grassley, and Mr. Blumenthal) introduced the
following bill; which was read twice and referred to the Committee on
Finance
_______________________________________________________________________
A BILL
To amend title XVIII of the Social Security Act to provide for the
implementation of prescriber education programs and to establish
requirements relating to the administration of antipsychotics to
residents of skilled nursing facilities and nursing facilities under
the Medicare and Medicaid programs, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Improving Dementia Care Treatment
for Older Adults Act of 2012''.
SEC. 2. FINDINGS.
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.
SEC. 3. PRESCRIBER EDUCATION PROGRAMS.
(a) In General.--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) Funding.--
``(i) Transfer.--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 programs.--There 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) In general.--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) Implementation.--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) Definitions.--In this paragraph:
``(i) Prescriber education programs.--The
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) Off-label marketing.--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) Conforming Amendment.--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''.
SEC. 4. REVIEW AND REPORTING OF ANTIPSYCHOTICS PRESCRIBED TO RESIDENTS
WITH DEMENTIA.
(a) Skilled Nursing Facilities.--
(1) In general.--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) In general.--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) Availability of reports.--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) Nursing Facilities.--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) In general.--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) Availability of reports.--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) Effective Date.--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.
SEC. 5. STANDARDIZED PROTOCOL FOR OBTAINING INFORMED CONSENT FROM AN
OLDER ADULT WITH DEMENTIA PRIOR TO PRESCRIBING AN
ANTIPSYCHOTIC.
(a) Standardized Protocol.--
(1) Skilled nursing facilities.--Section 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) Protocol.--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) Requirements.--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 consent.--Under 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) Compliance.--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) No preemption.--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) Nursing facilities.--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) Protocol.--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) Requirements.--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 consent.--Under 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) Compliance.--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) No preemption.--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) Study.--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) Report.--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) Medicare.--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) In general.--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) Considerations.--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) Medicaid.--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) In general.--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) Considerations.--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.''.
SEC. 6. GAO STUDY AND REPORT ON STANDARDIZED PROTOCOL FOR OBTAINING
INFORMED CONSENT.
(a) Study.--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) Report.--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.
SEC. 7. IOM STUDY AND REPORT ON USE OF ANTIPSYCHOTICS ACROSS CARE
SETTINGS.
(a) Study.--
(1) In general.--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 use.--The 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) Consultation.--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) Report.--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.
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