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[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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