Sec. 8. Standardized protocol for obtaining informed consent from residents prior to prescribing psychotropic drugs
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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: Not later than the date that is one year after the date of the enactment of this paragraph, the Secretary, taking into account the results of the study conducted by the Comptroller General of the United States under section 8(a)(3) of the Quality Care for Nursing Home Residents Act and in consultation with stakeholder groups (including residents of skilled nursing facilities, family members of such residents, advocates for such residents, long-term care ombudsmen, and providers), shall develop a standardized protocol for skilled nursing facilities to obtain written informed consent, in accordance with this paragraph, from a resident (or, if applicable, the resident’s designated health care agent or other surrogate under State law or regulation) prior to prescribing a psychotropic drug to the resident for a use not approved by the Food and Drug Administration.
The standardized protocol developed under subparagraph
(A)shall include the following: A requirement, with respect to a resident, that— the facility, with the involvement of the prescriber, inform the resident (or, if applicable, the resident’s designated health care agent or other surrogate under State law or regulation) of— possible side effects and risks associated with the psychotropic drug, including the mention of any black box warning ; treatment modalities that were attempted prior to the use of the psychotropic drug; and any other information the Secretary determines appropriate; the resident (or, if applicable, the resident’s designated health care agent or other surrogate under State law or regulation) provide written informed consent to the administration of the psychotropic drug; and the administration of the psychotropic drug is in accordance with any plan of care that the resident 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 written 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. Under the standardized protocol, a skilled nursing facility shall obtain the written informed consent described in subparagraph (A), with respect to a psychotropic drug and a resident of the facility— prior to the initial prescribing of such psychotropic drug to such resident if such resident does not have a current prescription for such psychotropic drug at the time such resident is admitted to the facility; and at least once a month to the extent that the administration of such psychotropic drug to such resident is in accordance with the plan of care that the resident has in place. Effective beginning on the date that is one year and 180 days after the date of the enactment of this paragraph, a skilled nursing facility shall comply with the standardized protocol developed under subparagraph (A). Nothing in this paragraph shall preempt any provision of State or Federal law that provides broader rights with respect to written informed consent for residents of 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: Not later than the date that is one year after the date of the enactment of this paragraph, the Secretary, taking into account the results of the study conducted by the Comptroller General of the United States under section 8(a)(3) of the Quality Care for Nursing Home Residents Act and in consultation with stakeholder groups (including residents of skilled nursing facilities, family members of such residents, advocates for such residents, long-term care ombudsmen, and providers), shall develop a standardized protocol for nursing facilities to obtain written informed consent, in accordance with this paragraph, from a resident (or, if applicable, the resident’s designated health care agent or other surrogate under State law or regulation) prior to prescribing a psychotropic drug to the resident for a use not approved by the Food and Drug Administration. The standardized protocol developed under subparagraph
(A)shall include the following: A requirement, with respect to a resident, that— the facility, with the involvement of the prescriber, inform the resident (or, if applicable, the resident’s designated health care agent or other surrogate under State law or regulation) of— possible side effects and risks associated with the psychotropic drug, including the mention of any black box warning ; treatment modalities that were attempted prior to the use of the psychotropic drug; and any other information the Secretary determines appropriate; the resident (or, if applicable, the resident’s designated health care agent or other surrogate under State law or regulation) provide written informed consent to the administration of the psychotropic drug; and the administration of the psychotropic drug is in accordance with any plan of care that the resident 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 written 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. Under the standardized protocol, a nursing facility shall obtain the written informed consent described in subparagraph (A), with respect to a psychotropic drug and a resident of the facility— prior to the initial prescribing of such psychotropic drug to such resident if such resident does not have a current prescription for such psychotropic drug at the time such resident is admitted to the facility; and at least once a month to the extent that the administration of such psychotropic drug to such resident is in accordance with the plan of care that the resident has in place. Effective beginning on the date that is one year and 180 days after the date of the enactment of this paragraph, a nursing facility shall comply with the standardized protocol developed under subparagraph (A). Nothing in this paragraph shall preempt any provision of State or Federal law that provides broader rights with respect to written informed consent for residents of facilities. . 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 a psychotropic drug with regard to the effectiveness of such laws and practices in changing the frequency of prescribing of psychotropic drugs to older adults. 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 psychotropic drugs in older adults with dementia. Not later than 180 days after the date of enactment of this Act, the Comptroller General shall submit to the Secretary of Health and Human Services, the Committees on Energy and Commerce and Ways and Means of the House of Representatives, and the Committee on Finance of the Senate a report containing the results of the study conducted under subparagraph (A), together with such recommendations as the Comptroller General determines appropriate. Section 1819(i) of the Social Security Act ( 42 U.S.C. 1395i–3(i) ) is amended— by redesignating paragraph
(3)as paragraph (4); and by inserting after paragraph
(2)the following new paragraph: Not later than the date that is one year after the date of the enactment of this paragraph, the Secretary shall include a measure of the utilization of psychotropic drugs for each skilled nursing facility for inclusion on such website (or a successor website) as part of the quality measures or health inspections measures, or both such measures, under the Five-Star Quality Rating System established by the Administrator of the Centers for Medicare & Medicaid Services. 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. . Section 1919(i) of the Social Security Act ( 42 U.S.C. 1396r(i) ) is amended— by redesignating paragraph
(3)as paragraph (4); and by inserting after paragraph
(2)the following new paragraph: Not later than the date that is one year after the date of the enactment of this paragraph, the Secretary shall include a measure of the utilization of psychotropic drugs for each nursing facility for inclusion on such website (or a successor website) as part of the quality measures or health inspections measures, or both such measures, under the Five-Star Quality Rating System established by the Administrator of the Centers for Medicare & Medicaid Services. 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. .
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- 42 USC 1395i–3(b)
- 42 USC 1395i–3(i)
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Sec. 8
Standardized protocol for obtaining informed consent from residents prior to prescribing psychotropic drugs
Cite42 USC 1395i–3(b)
Cite42 USC 1395i–3(i)
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