II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Improving Dementia 

5 Care Treatment for Older Adults Act of 2012’’. 


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1 SEC. 2. FINDINGS. 

2 Congress makes the following findings: 

3 (1) More than 5,000,000 Americans are af4 flicted with Alzheimer’s and related dementias, and 

5 that number is projected to reach as much as 

6 16,000,000 during the boomer’s ‘‘age wave’’ in the 

7 first half of the 21st century. 

8 (2) Nearly 40 percent of individuals with de9 mentia living in nursing homes receive antipsychotic 

10 drugs. No antipsychotics have been approved by the 

11 Food and Drug Administration to treat dementia. 

12 (3) The potential harms of antipsychotics in 

13 frail elders are significant. Studies show that for 

14 every 53 patients with dementia who are treated 

15 with such a pharmaceutical, one will die. For every 

16 9 to 25 patients that benefit from an antipsychotic, 

17 one will die. 

18 (4) A May 2011 report issued by the Office of 

19 Inspector General of the Department of Health and 

20 Human Services found that 305,000, or 14 percent, 

21 of the Nation’s 2,100,000 nursing home residents 

22 had at least one claim for antipsychotics. The report 

23 documented that 83 percent of Medicare claims for 

24 atypical antipsychotic drugs for elderly nursing home 

25 residents were associated with off-label conditions, 


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1 and that antipsychotics are often prescribed to man2 age behavioral symptoms of patients with dementia. 

3 (5) In 2005 and 2008, the Food and Drug Ad4 ministration issued ‘‘black box warnings’’—the 

5 strongest possible warning—stating that patients 

6 administered antipsychotics face a risk of death 1.6 

7 to 1.7 times greater than those who take a placebo. 

8 (6) Despite these significant warnings, 

9 antipsychotic prescription rates in long-term care fa10 cilities for patients with dementia and no diagnosis 

11 of psychosis are high. In 1999, 39 percent of elderly 

12 nursing home residents with dementia and aggres13 sive behavioral symptoms received antipsychotics 

14 within a one-week period. By 2006, the use of 

15 antipsychotics among nursing home residents with 

dementia had increased by almost 1⁄3 to over 1 16 ⁄2 of 

17 these residents in some facilities. According to the 

18 Department of Health and Human Services, the cur19 rent national average utilization rate of 

20 antipsychotics is 24 percent among long-stay resi21 dents. 

22 (7) The cost to taxpayers associated with the 

23 overutilization of antipsychotics is high. Since 2007, 

24 the Federal government has collected more than 

25 $3,000,000,000 in settlements for illegal off-label 


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1 marketing of antipsychotics. In a June 2011 lawsuit, 

2 a Circuit Court Judge fined a company 

3 $327,000,000 for deceptive marketing of an 

4 antipsychotic, and concluded that the company dis5 played ‘‘a callous disregard to a patient’s right to 

6 have all information available’’. 

7 (8) In late 2011, the Chief Medical Officer of 

8 the Centers for Medicare & Medicaid Services testi9 fied before the Special Committee on Aging of the 

10 Senate that 75 percent of Americans who are diag11 nosed with Alzheimer’s will be admitted to a nursing 

12 home by age 80. 

13 (9) Leading medical experts and organizations 

14 advise that individuals with dementia who display 

15 agitation and disruptive behaviors are often trying to 

16 communicate, and their failure to be able to do so 

17 can result in frustration and ‘‘acting out’’. The re18 sulting agitation and disruptive behaviors may sig19 nify unmet needs or symptoms, including pain, con20 stipation, negative responses to noise, or interaction 

21 with other individuals. 

22 (10) The American Medical Directors Associa23 tion advises practitioners to address the underlying 

24 causes and factors contributing to behavioral symp25 toms through a ‘‘detailed review of a patient’s sympVerDate Mar 15 2010 02:05 Sep 27, 2012 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S3604.IS S3604

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1 tom history and a careful assessment of the cir2 cumstances in which problematic behavior occurs as 

3 a basis for both medication treatment and non-phar4 macological interventions.’’ 

5 (11) LeadingAge advises that ‘‘family members 

6 and professional caretakers ought to try first to un7 derstand what the patient is trying to convey. Then, 

8 they can take appropriate action.’’ LeadingAge also 

9 notes that there is a ‘‘growing body of evidence that 

10 supports the effectiveness of behavioral modifications 

11 and non-pharmacological interventions to manage 

12 dementia.’’ 

13 (12) In May 2012, the Centers for Medicare & 

14 Medicaid Services set a goal of reducing the utiliza15 tion of antipsychotics in long-term care facilities by 

16 15 percent by the end of the year. The Partnership 

17 to Improve Dementia Care is a collaborative effort 

18 with industry and advocacy partners to improve 

19 training in nursing homes and to further develop ap20 propriate alternatives to antipsychotics for nursing 

21 homes to use in providing care to residents who do 

22 not have a specific clinical indication for the use of 

23 those agents. 


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1 SEC. 3. PRESCRIBER EDUCATION PROGRAMS. 

2 (a) IN GENERAL.—Section 1817(k) of the Social Se3 curity Act (42 U.S.C. 1395i(k)) is amended by adding at 

4 the end the new paragraph: 

5 ‘‘(9) PRESCRIBER EDUCATION PROGRAMS.— 

6 ‘‘(A) FUNDING.— 

7 ‘‘(i) TRANSFER.—The Managing 

8 Trustee shall transfer to the Trust Fund, 

9 under rules similar to the rules described 

10 in paragraph (2)(C), an amount equal to 

11 the penalties and damages obtained and 

12 otherwise creditable to miscellaneous re13 ceipts of the general fund of the Treasury 

14 obtained under sections 3729 through 

15 3733 of title 31, United States Code 

16 (known as the False Claims Act), in cases 

17 involving claims related to the off-label 

18 marketing of any prescription drug (other 

19 than funds awarded to a relator, for res20 titution, or otherwise authorized by law). 

21 ‘‘(ii) APPROPRIATED AMOUNTS TO AC22 COUNT FOR PRESCRIBER EDUCATION PRO23 GRAMS.—There are hereby appropriated to 

24 the Account from the Trust Fund some 

25 portion of such amounts transferred to the 

26 Trust Fund under clause (i), to be availVerDate Mar 15 2010 02:05 Sep 27, 2012 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S3604.IS S3604

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1 able without further appropriation until ex2 pended, for purposes of carrying out pre3 scriber education programs and other ac4 tivities in accordance with this paragraph. 

5 ‘‘(B) PRESCRIBER EDUCATION PRO6 GRAMS.— 

7 ‘‘(i) IN GENERAL.—The Secretary, 

8 acting through the Centers for Medicare 

9 and Medicaid Services, in consultation with 

10 the Director of the Agency for Healthcare 

11 Research and Quality and the Commis12 sioner of Food and Drugs, shall establish 

13 and implement prescriber education pro14 grams. 

15 ‘‘(ii) IMPLEMENTATION.—The Sec16 retary shall establish and begin implemen17 tation of prescriber education programs 

18 under this paragraph by not later than 6 

19 months after the date on which funds are 

20 first made available to the Account under 

21 subparagraph (A). 

22 ‘‘(C) DEFINITIONS.—In this paragraph: 

23 ‘‘(i) PRESCRIBER EDUCATION PRO24 GRAMS.—The term ‘prescriber education 

25 program’ means a program to promote 


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1 high quality evidence-based treatment, in2 cluding appropriate use of medications and 

3 non-pharmacologic interventions, through 

4 the development and dissemination of ob5 jective, educational, and informational ma6 terials to physicians and other prescribing 

7 practitioners, including such a program de8 veloped by the Agency for Healthcare Re9 search and Quality. 

10 ‘‘(ii) OFF-LABEL MARKETING.—The 

11 term ‘off-label marketing’ means the mar12 keting of a prescription drug for an indica13 tion or use in a manner for which the drug 

14 has not been approved by the Food and 

15 Drug Administration.’’. 

16 (b) CONFORMING AMENDMENT.—Section 

17 1817(k)(2)(C)(iv) of the Social Security Act (42 U.S.C. 

18 1395i(k)(2)(C)(iv)) is amended by inserting ‘‘, for the con19 duct of prescriber education programs and other activities 

20 in accordance with paragraph (9),’’ after ‘‘restitution’’. 

21 SEC. 4. REVIEW AND REPORTING OF ANTIPSYCHOTICS 

22 PRESCRIBED TO RESIDENTS WITH DEMEN23 TIA. 

24 (a) SKILLED NURSING FACILITIES.— 


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1 (1) IN GENERAL.—Section 1819(b) of the So2 cial Security Act (42 U.S.C. 1395i–3(b)) is amended 

3 by adding at the end the following new paragraph: 

4 ‘‘(9) REVIEW AND REPORTING OF

5 ANTIPSYCHOTICS PRESCRIBED TO RESIDENTS WITH

6 DEMENTIA.— 

7 ‘‘(A) IN GENERAL.—As part of the drug 

8 regimen review process under this section (as 

9 described in section 483.60(c) of title 42, Code 

10 of Federal Regulations), the pharmacist con11 ducting such review with respect to a skilled 

12 nursing facility shall— 

13 ‘‘(i) note any instance where an 

14 antipsychotic was prescribed for a resident 

15 of the facility with dementia for a use not 

16 approved by the Food and Drug Adminis17 tration; and 

18 ‘‘(ii) submit to the administrator, 

19 medical director, and director of nursing of 

20 the facility a monthly report containing ag21 gregate information regarding any in22 stances noted under clause (i) during the 

23 preceding month. 

24 ‘‘(B) AVAILABILITY OF REPORTS.—A 

25 skilled nursing facility must— 


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1 ‘‘(i) upon receipt of a report sub2 mitted to the facility under subparagraph 

3 (A)(ii), submit such report to the Sec4 retary; and 

5 ‘‘(ii) make such reports available to 

6 surveyors and the State Long-Term Care 

7 Ombudsman described in section 712 of 

8 the Older Americans Act of 1965.’’. 

9 (b) NURSING FACILITIES.—Section 1919(b) of the 

10 Social Security Act (42 U.S.C. 1396r(b)) is amended by 

11 adding at the end the following new paragraph: 

12 ‘‘(9) REVIEW AND REPORTING OF

13 ANTIPSYCHOTICS PRESCRIBED TO RESIDENTS WITH

14 DEMENTIA.— 

15 ‘‘(A) IN GENERAL.—As part of the drug 

16 regimen review process under this section (as 

17 described in section 483.60(c) of title 42, Code 

18 of Federal Regulations), the pharmacist con19 ducting such review with respect to a nursing 

20 facility shall— 

21 ‘‘(i) note any instance where an 

22 antipsychotic was prescribed for a resident 

23 of the facility with dementia for a use not 

24 approved by the Food and Drug Adminis25 tration; and 


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1 ‘‘(ii) submit to the administrator, 

2 medical director, and director of nursing of 

3 the facility a monthly report containing ag4 gregate information regarding any in5 stances noted under clause (i) during the 

6 preceding month. 

7 ‘‘(B) AVAILABILITY OF REPORTS.—A nurs8 ing facility must— 

9 ‘‘(i) upon receipt of a report sub10 mitted to the facility under subparagraph 

11 (A)(ii), submit such report to the Sec12 retary; and 

13 ‘‘(ii) make such reports available to 

14 surveyors and the State Long-Term Care 

15 Ombudsman described in section 712 of 

16 the Older Americans Act of 1965.’’. 

17 (c) EFFECTIVE DATE.—The amendments made by 

18 this section shall take effect on the date that is 1 year 

19 after the date of the enactment of this Act and apply to 

20 reviews conducted with respect to drugs dispensed or ad21 ministered on or after such date. 


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1 SEC. 5. STANDARDIZED PROTOCOL FOR OBTAINING IN2 FORMED CONSENT FROM AN OLDER ADULT 

3 WITH DEMENTIA PRIOR TO PRESCRIBING AN 

4 ANTIPSYCHOTIC. 

5 (a) STANDARDIZED PROTOCOL.— 

6 (1) SKILLED NURSING FACILITIES.—Section 

7 1819(b) of the Social Security Act (42 U.S.C. 

8 1395i–3(b)), as amended by section 4, is amended 

9 by adding at the end the following new paragraph: 

10 ‘‘(10) STANDARDIZED PROTOCOL FOR OBTAIN11 ING INFORMED CONSENT FROM AN OLDER ADULT

12 WITH DEMENTIA PRIOR TO PRESCRIBING AN

13 ANTIPSYCHOTIC FOR A USE NOT APPROVED BY THE

14 FOOD AND DRUG ADMINISTRATION.— 

15 ‘‘(A) PROTOCOL.—Not later than 180 days 

16 after the date on which the Comptroller General 

17 submits the report on State informed consent 

18 laws under section 5(a)(3) of the Improving De19 mentia Care Treatment for Older Adults Act of 

20 2012, the Secretary shall develop a standard21 ized protocol for skilled nursing facilities to ob22 tain informed consent from an older adult with 

23 dementia (or, if applicable, the older adult’s 

24 designated health care agent or other surrogate 

25 under State law or regulation) prior to pre26 scribing an antipsychotic to the older adult for 


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1 a use not approved by the Food and Drug Ad2 ministration. 

3 ‘‘(B) REQUIREMENTS.—The standardized 

4 protocol developed under subparagraph (A) 

5 shall include the following: 

6 ‘‘(i) A requirement, with respect to an 

7 older adult with dementia, that— 

8 ‘‘(I) the facility, with the involve9 ment of the prescriber, inform the 

10 older adult (or, if applicable, the older 

11 adult’s designated health care agent 

12 or other surrogate under State law or 

13 regulation) of— 

14 ‘‘(aa) possible side effects 

15 and risks associated with the 

16 antipsychotic, including the men17 tion of any ‘black box warning’; 

18 ‘‘(bb) treatment modalities 

19 that were attempted prior to the 

20 use of the antipsychotic; and 

21 ‘‘(cc) any other information 

22 the Secretary determines appro23 priate; 

24 ‘‘(II) the older adult (or, if appli25 cable, the older adult’s designated 


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1 health care agent or other surrogate 

2 under State law or regulation) provide 

3 consent to the administration of the 

4 antipsychotic; and 

5 ‘‘(III) the administration of the 

6 antipsychotic is in accordance with 

7 any plan of care that the older adult 

8 has in place, including non-pharma9 cological interventions as appropriate 

10 that can effectively address underlying 

11 medical and environmental causes of 

12 behavioral disorders. 

13 ‘‘(ii) An alternative protocol for ob14 taining such informed consent— 

15 ‘‘(I) in the case of emergencies; 

16 and 

17 ‘‘(II) in the absence of a clearly 

18 identified designated health care agent 

19 or other surrogate under State law or 

20 regulation. 

21 ‘‘(iii) Other items determined appro22 priate by the Secretary. 

23 ‘‘(C) TIMING OF INFORMED CONSENT.— 

24 Under the standardized protocol, a skilled nurs25 ing facility shall obtain informed consent— 


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1 ‘‘(i) prior to the initial prescribing of 

2 antipsychotics; or 

3 ‘‘(ii) in the case of an individual al4 ready prescribed antipsychotics when ad5 mitted to a facility, the facility shall obtain 

6 informed consent if the facility maintains 

7 antipsychotic treatment after the first drug 

8 regimen review conducted with respect to 

9 the individual. 

10 ‘‘(D) COMPLIANCE.—Effective beginning 

11 on the date that is 18 months after the date of 

12 enactment of the Improving Dementia Care 

13 Treatment for Older Adults Act of 2012, a 

14 skilled nursing facility shall comply with the 

15 standardized protocol developed under subpara16 graph (A). 

17 ‘‘(E) NO PREEMPTION.—Nothing in this 

18 paragraph shall preempt any provision of State 

19 or Federal law that provides broader rights 

20 with respect to informed consent for residents 

21 of facilities.’’. 

22 (2) NURSING FACILITIES.—Section 1919(b) of 

23 the Social Security Act (42 U.S.C. 1396r(b)), as 

24 amended by section 4, is amended by adding at the 

25 end the following new paragraph: 


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1 ‘‘(10) STANDARDIZED PROTOCOL FOR OBTAIN2 ING INFORMED CONSENT FROM AN OLDER ADULT

3 WITH DEMENTIA PRIOR TO PRESCRIBING AN

4 ANTIPSYCHOTIC FOR A USE NOT APPROVED BY THE

5 FOOD AND DRUG ADMINISTRATION.— 

6 ‘‘(A) PROTOCOL.—Not later than 180 days 

7 after the date on which the Comptroller General 

8 submits the report on State informed consent 

9 laws under section 5(a)(3) of the Improving De10 mentia Care Treatment for Older Adults Act of 

11 2012, the Secretary shall develop a standard12 ized protocol for nursing facilities to obtain in13 formed consent from an older adult with de14 mentia (or, if applicable, the older adult’s des15 ignated health care agent or other surrogate 

16 under State law or regulation) prior to pre17 scribing an antipsychotic to the older adult for 

18 a use not approved by the Food and Drug Ad19 ministration. 

20 ‘‘(B) REQUIREMENTS.—The standardized 

21 protocol developed under subparagraph (A) 

22 shall include the following: 

23 ‘‘(i) A requirement, with respect to an 

24 older adult with dementia, that— 


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1 ‘‘(I) the facility, with the involve2 ment of the prescriber, inform the 

3 older adult (or, if applicable, the older 

4 adult’s designated health care agent 

5 or other surrogate under State law or 

6 regulation) of— 

7 ‘‘(aa) possible side effects 

8 and risks associated with the 

9 antipsychotic, including the men10 tion of any ‘black box warning’; 

11 ‘‘(bb) treatment modalities 

12 that were attempted prior to the 

13 use of the antipsychotic; and 

14 ‘‘(cc) any other information 

15 the Secretary determines appro16 priate; 

17 ‘‘(II) the older adult (or, if appli18 cable, the older adult’s designated 

19 health care agent or other surrogate 

20 under State law or regulation) provide 

21 consent to the administration of the 

22 antipsychotic; and 

23 ‘‘(III) the administration of the 

24 antipsychotic is in accordance with 

25 any plan of care that the older adult 


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1 has in place, including non-pharma2 cological interventions as appropriate 

3 that can effectively address underlying 

4 medical and environmental causes of 

5 behavioral disorders. 

6 ‘‘(ii) An alternative protocol for ob7 taining such informed consent— 

8 ‘‘(I) in the case of emergencies; 

9 and 

10 ‘‘(II) in the absence of a clearly 

11 identified designated health care agent 

12 or other surrogate under State law or 

13 regulation. 

14 ‘‘(iii) Other items determined appro15 priate by the Secretary. 

16 ‘‘(C) TIMING OF INFORMED CONSENT.— 

17 Under the standardized protocol, a nursing fa18 cility shall obtain informed consent— 

19 ‘‘(i) prior to the initial prescribing of 

20 antipsychotics; or 

21 ‘‘(ii) in the case of an individual al22 ready prescribed antipsychotics when ad23 mitted to a facility, the facility shall obtain 

24 informed consent if the facility maintains 

25 antipsychotic treatment after the first drug 


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1 regimen review conducted with respect to 

2 the individual. 

3 ‘‘(D) COMPLIANCE.—Effective beginning 

4 on the date that is 18 months after the date of 

5 enactment of the Improving Dementia Care 

6 Treatment for Older Adults Act of 2012, a 

7 nursing facility shall comply with the standard8 ized protocol developed under subparagraph 

9 (A). 

10 ‘‘(E) NO PREEMPTION.—Nothing in this 

11 paragraph shall preempt any provision of State 

12 or Federal law that provides broader rights 

13 with respect to informed consent for residents 

14 of facilities.’’. 

15 (3) GAO STUDY AND REPORT ON INFORMED

16 CONSENT LAWS WITH RESPECT TO PRESCRIBING OF

17 AN ANTIPSYCHOTIC.— 

18 (A) STUDY.—The Comptroller General of 

19 the United States (in this paragraph referred to 

20 as the ‘‘Comptroller General’’) shall conduct a 

21 study of State laws and regulations concerning 

22 informed consent with respect to the adminis23 tration of an antipsychotic (or other 

24 psychoactive medication) with regard to the ef25 fectiveness of such laws and practices in changVerDate Mar 15 2010 02:05 Sep 27, 2012 Jkt 019200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6201 E:\BILLS\S3604.IS S3604

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1 ing the frequency of prescribing of 

2 antipsychotics (or other psychoactive medica3 tions) to older adults with dementia. The study 

4 shall include an analysis as to whether in the 

5 case of States that have not enacted such in6 formed consent laws, such States have devel7 oped other mechanisms to guide appropriate 

8 prescribing of antipsychotics in older adults 

9 with dementia. 

10 (B) REPORT.—Not later than 180 days 

11 after the date of enactment of this Act, the 

12 Comptroller General shall submit to the Sec13 retary and to Congress a report containing the 

14 results of the study conducted under subpara15 graph (A), together with such recommendations 

16 as the Comptroller General determines appro17 priate. 

18 (b) DEVELOPMENT OF MEASURE OF UTILIZATION OF

19 ANTIPSYCHOTICS FOR INCLUSION ON NURSING HOME

20 COMPARE WEBSITE.— 

21 (1) MEDICARE.—Section 1819(i) of the Social 

22 Security Act (42 U.S.C. 1395i–3(i)) is amended by 

23 adding at the end the following new paragraph: 

24 ‘‘(3) DEVELOPMENT OF MEASURE OF UTILIZA25 TION OF ANTIPSYCHOTICS.— 


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1 ‘‘(A) IN GENERAL.—The Secretary shall 

2 include a measure of the utilization of 

3 antipsychotics for each facility for inclusion on 

4 such website (or a successor website) as part of 

5 the quality measures or health inspection meas6 ures, or both such measures, under the Five7 Star Quality Rating System. 

8 ‘‘(B) CONSIDERATIONS.—In developing the 

9 measure under subparagraph (A), the Secretary 

10 shall take into account special patient popu11 lations, special care units, appropriate diag12 noses, and other factors, as determined appro13 priate by the Secretary.’’. 

14 (2) MEDICAID.—Section 1919(i) of the Social 

15 Security Act (42 U.S.C. 1396r(i)) is amended by 

16 adding at the end the following new paragraph: 

17 ‘‘(3) DEVELOPMENT OF MEASURE OF UTILIZA18 TION OF ANTIPSYCHOTICS.— 

19 ‘‘(A) IN GENERAL.—The Secretary shall 

20 include a measure of the utilization of 

21 antipsychotics for each facility for inclusion on 

22 such website (or a successor website) as part of 

23 the quality measures or health inspection meas24 ures, or both such measures, under the Five25 Star Quality Rating System. 


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1 ‘‘(B) CONSIDERATIONS.—In developing the 

2 measure under subparagraph (A), the Secretary 

3 shall take into account special patient popu4 lations, special care units, appropriate diag5 noses, and other factors, as determined appro6 priate by the Secretary.’’. 

7 SEC. 6. GAO STUDY AND REPORT ON STANDARDIZED PRO8 TOCOL FOR OBTAINING INFORMED CONSENT. 

9 (a) STUDY.—The Comptroller General of the United 

10 States (in this section referred to as the ‘‘Comptroller 

11 General’’) shall conduct a study to analyze the impact of 

12 the standardized protocol for obtaining informed consent 

13 under sections 1819(b)(10) and 1919(b)(10) of the Social 

14 Security Act, as added by paragraphs (1) and (2), respec15 tively, of section 5(a). Such study shall include an analysis 

16 of— 

17 (1) whether changes in the utilization of 

18 antipsychotics in selected facilities resulted in im19 proved quality of life for residents; 

20 (2) whether changes in the utilization of 

21 antipsychotics in selected facilities resulted in trans22 fer of residents to other settings for psychiatric care; 

23 (3) whether selected facilities adopted greater 

24 use of alternative treatment modalities, including 


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1 non-pharmacologic interventions and individualized, 

2 person-centered techniques; 

3 (4) whether the standardized protocol resulted 

4 in diminished access to antipsychotics among indi5 viduals with a diagnosis of mental illness; 

6 (5) whether the standardized protocol resulted 

7 in physicians and other prescribers switching from 

8 prescribing antipsychotics to prescribing other 

9 sedating psychoactive medications; and 

10 (6) the prevalence of antipsychotic prescribing 

11 for older adults outside of the skilled nursing facility 

12 or nursing facility setting, including in hospitals and 

13 assisted living communities. 

14 (b) REPORT.—Not later than 2 years after the com15 pliance date under subparagraph (D) of each of such sec16 tions 1819(b)(10) and 1919(b)(10), the Comptroller Gen17 eral shall submit to the Secretary and to Congress a report 

18 containing the results of the study conducted under sub19 section (a), together with such recommendations as the 

20 Comptroller General determines appropriate. 

21 SEC. 7. IOM STUDY AND REPORT ON USE OF 

22 ANTIPSYCHOTICS ACROSS CARE SETTINGS. 

23 (a) STUDY.— 

24 (1) IN GENERAL.—The Secretary of Health and 

25 Human Services (in this section referred to as the 


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1 ‘‘Secretary’’) shall seek to enter into an agreement 

2 with the Institute of Medicine of the National Acad3 emies to conduct a study on— 

4 (A) the appropriate prescribing of 

5 antipsychotics for hospital inpatients; and 

6 (B) whether documentation of 

7 antipsychotic use in patients with dementia is 

8 provided during transitions of care from hos9 pitals to other care settings. 

10 (2) ANALYSIS OF PATTERNS OF USE.—The 

11 study conducted under paragraph (1) shall include 

12 an analysis by the Institute of Medicine of the pat13 terns of use of antipsychotics in older adults with 

14 dementia that originate in ambulatory settings. 

15 (3) CONSULTATION.—Under the agreement 

16 under paragraph (1), the Institute of Medicine shall 

17 consult with leaders in the hospital and medical care 

18 sector, the long-term care industry, the pharmacy 

19 community, representatives of nursing home resi20 dents and family caregivers, leading experts in psy21 chiatry and geriatrics, and other entities or individ22 uals determined appropriate by the Secretary in con23 ducting the study under the preceding sentence. 

24 (b) REPORT.—The agreement entered into under 

25 subsection (a) shall provide for the Institute of Medicine 


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1 to submit to the Secretary and to Congress a report con2 taining the results of the study conducted under such sub3 section. 

Æ 


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