II
112th CONGRESS
2d Session
S. 3604
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.
Short title
This Act may be cited as
the Improving Dementia Care Treatment
for Older Adults Act of 2012
.
Findings
Congress makes the following findings:
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.
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.
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.
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.
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.
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.
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
.
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.
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.
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.
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.
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.
Prescriber education programs
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:
Prescriber education programs
Funding
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).
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.
Prescriber education programs
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.
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).
Definitions
In this paragraph:
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.
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.
.
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
.
Review and reporting of antipsychotics prescribed to residents with dementia
Skilled nursing facilities
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:
Review and reporting of antipsychotics prescribed to residents with dementia
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—
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
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.
Availability of reports
A skilled nursing facility must—
upon receipt of a report submitted to the facility under subparagraph (A)(ii), submit such report to the Secretary; and
make such reports available to surveyors and the State Long-Term Care Ombudsman described in section 712 of the Older Americans Act of 1965.
.
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:
Review and reporting of antipsychotics prescribed to residents with dementia
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—
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
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.
Availability of reports
A nursing facility must—
upon receipt of a report submitted to the facility under subparagraph (A)(ii), submit such report to the Secretary; and
make such reports available to surveyors and the State Long-Term Care Ombudsman described in section 712 of the Older Americans Act of 1965.
.
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.
Standardized protocol for obtaining informed consent from an older adult with dementia prior to prescribing an antipsychotic
Standardized protocol
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:
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
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.
Requirements
The standardized protocol developed under subparagraph (A) shall include the following:
A requirement, with respect to an older adult with dementia, that—
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—
possible side
effects and risks associated with the antipsychotic, including the mention of
any black box warning
;
treatment modalities that were attempted prior to the use of the antipsychotic; and
any other information the Secretary determines appropriate;
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
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.
An alternative protocol for obtaining such informed consent—
in the case of emergencies; and
in the absence of a clearly identified designated health care agent or other surrogate under State law or regulation.
Other items determined appropriate by the Secretary.
Timing of informed consent
Under the standardized protocol, a skilled nursing facility shall obtain informed consent—
prior to the initial prescribing of antipsychotics; or
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.
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).
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.
.
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:
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
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.
Requirements
The standardized protocol developed under subparagraph (A) shall include the following:
A requirement, with respect to an older adult with dementia, that—
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—
possible side
effects and risks associated with the antipsychotic, including the mention of
any black box warning
;
treatment modalities that were attempted prior to the use of the antipsychotic; and
any other information the Secretary determines appropriate;
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
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.
An alternative protocol for obtaining such informed consent—
in the case of emergencies; and
in the absence of a clearly identified designated health care agent or other surrogate under State law or regulation.
Other items determined appropriate by the Secretary.
Timing of informed consent
Under the standardized protocol, a nursing facility shall obtain informed consent—
prior to the initial prescribing of antipsychotics; or
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.
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).
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.
.
GAO study and report on informed consent laws with respect to prescribing of an antipsychotic
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.
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.
Development of measure of utilization of antipsychotics for inclusion on nursing home compare website
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:
Development of measure of utilization of antipsychotics
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.
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.
.
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:
Development of measure of utilization of antipsychotics
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.
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.
.
GAO study and report on standardized protocol for obtaining informed consent
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—
whether changes in the utilization of antipsychotics in selected facilities resulted in improved quality of life for residents;
whether changes in the utilization of antipsychotics in selected facilities resulted in transfer of residents to other settings for psychiatric care;
whether selected facilities adopted greater use of alternative treatment modalities, including non-pharmacologic interventions and individualized, person-centered techniques;
whether the standardized protocol resulted in diminished access to antipsychotics among individuals with a diagnosis of mental illness;
whether the standardized protocol resulted in physicians and other prescribers switching from prescribing antipsychotics to prescribing other sedating psychoactive medications; and
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.
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.
IOM study and report on use of antipsychotics across care settings
Study
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—
the appropriate prescribing of antipsychotics for hospital inpatients; and
whether documentation of antipsychotic use in patients with dementia is provided during transitions of care from hospitals to other care settings.
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.
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.
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.
