Lali's Law

Bill: 114-hr-4586
Sponsor: full_name: Rep. Dold, Robert J. [R-IL-10]
Introduced: 2016-02-23
Policy area: Health
Subjects: Drug therapy

Drug trafficking and controlled substances

Drug, alcohol, tobacco use

Emergency medical services and trauma care

First responders and emergency personnel

Health programs administration and funding

Health promotion and preventive care

Prescription drugs
Latest action: action_date: 2016-05-16
text: Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2016-02-23
action_desc: Introduced in House
text: <p><b>Lali's Law</b></p> <p>This bill amends the Public Health Service Act to permit the Centers for Disease Control and Prevention to make grants to states that allow standing orders (documents that allow a person to acquire, dispense, or administer a prescription medication without a person-specific prescription) for opioid overdose reversal medication (e.g., naloxone). (Opioids are drugs with effects similar to opium, such as heroin and certain pain medications.)</p> <p>Grants may be used for:</p> <ul> <li> developing standing orders for opioid overdose reversal medication for pharmacies;</li> <li>encouraging pharmacies to dispense medication pursuant to such a standing order;</li> <li>implementing guidelines and best practices for prescribing opioids, prescribing opioid overdose reversal medication with opioids, and discussing opioid overdose reversal medication with patients;</li> <li>developing training for prescribers to use in educating the public on administration of opioid overdose reversal medication; and</li> <li>educating the public on the availability and public health benefits of opioid overdose reversal medication.</li> </ul> States must report on pharmacies that dispense opioid overdose reversal medication under a standing order and the number of pharmacists trained in educating the public on administration of opioid overdose reversal medication.

action_date: 2016-05-10
action_desc: Reported to House with amendment(s)
text: <p><b>Lali's Law</b></p> <p>(Sec. 2) This bill amends the Public Health Service Act to permit the Department of Health and Human Services to make grants to states that allow standing orders (documents that allow a person to acquire, dispense, or administer a prescription medication without a person-specific prescription) for opioid overdose reversal medication (e.g., naloxone). (Opioids are drugs with effects similar to opium, such as heroin and certain pain medications.)</p> <p>Grants may be used for:</p> <ul> <li> developing standing orders for opioid overdose reversal medication for pharmacies;</li> <li>encouraging pharmacies to dispense medication pursuant to such a standing order;</li> <li>implementing best practices for prescribing opioids, prescribing opioid overdose reversal medication with opioids, and discussing opioid overdose reversal medication with patients;</li> <li>developing training for prescribers to use in educating the public on administration of opioid overdose reversal medication; and</li> <li>educating the public on the availability and public health benefits of opioid overdose reversal medication.</li> </ul> <p>States must report on pharmacies that dispense opioid overdose reversal medication under a standing order and the number of pharmacists trained in educating the public on administration of opioid overdose reversal medication. </p> <p>(Sec. 3) As an offset, this bill reduces the authorization of appropriations for Centers for Disease Control and Prevention facilities.</p>

action_date: 2016-05-12
action_desc: Passed House amended
text: <p>(This measure has not been amended since it was reported to the House on May 10, 2016. The summary of that version is repeated here.)</p> <p><b>Lali's Law</b></p> <p>(Sec. 2) This bill amends the Public Health Service Act to permit the Department of Health and Human Services to make grants to states that allow standing orders (documents that allow a person to acquire, dispense, or administer a prescription medication without a person-specific prescription) for opioid overdose reversal medication (e.g., naloxone). (Opioids are drugs with effects similar to opium, such as heroin and certain pain medications.)</p> <p>Grants may be used for:</p> <ul> <li> developing standing orders for opioid overdose reversal medication for pharmacies;</li> <li>encouraging pharmacies to dispense medication pursuant to such a standing order;</li> <li>implementing best practices for prescribing opioids, prescribing opioid overdose reversal medication with opioids, and discussing opioid overdose reversal medication with patients;</li> <li>developing training for prescribers to use in educating the public on administration of opioid overdose reversal medication; and</li> <li>educating the public on the availability and public health benefits of opioid overdose reversal medication.</li> </ul> <p>States must report on pharmacies that dispense opioid overdose reversal medication under a standing order and the number of pharmacists trained in educating the public on administration of opioid overdose reversal medication. </p> <p>(Sec. 3) As an offset, this bill reduces the authorization of appropriations for Centers for Disease Control and Prevention facilities.</p>

tv_txt: I 114th CONGRESS 2d Session H. R. 4586 IN THE HOUSE OF REPRESENTATIVES February 23, 2016 Mr. Dold (for himself and Ms. Clark of Massachusetts ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Public Health Service Act to authorize grants to States for developing standing orders and educating health care professionals regarding the dispensing of opioid overdose reversal medication without person-specific prescriptions, and for other purposes.

1. Short title This Act may be cited as Lali’s Law . 2. Opioid overdose reversal medication access and education grant programs Part B of title III of the Public Health Service Act is amended by inserting after section 317T of such Act ( 42 U.S.C. 247b–22 ) the following: 317U. Opioid Overdose Reversal Medication Access and Education Grant Programs (a) Grants to States The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States for— (1) developing standing orders for pharmacies regarding opioid overdose reversal medication; (2) encouraging pharmacies to dispense opioid overdose reversal medication pursuant to a standing order; (3) implementing guidelines and best practices for persons authorized to prescribe medication regarding— (A) prescribing opioids for the treatment of chronic pain; (B) co-prescribing opioid overdose reversal medication with opioids; and (C) discussing the purpose and administration of opioid overdose reversal medication with patients; (4) developing or adapting training materials and methods for persons authorized to prescribe or dispense medication to use in educating the public regarding— (A) when and how to administer opioid overdose reversal medication; and (B) steps to be taken after administering opioid overdose reversal medication; and (5) educating the public regarding— (A) the public health benefits of opioid overdose reversal medication; and (B) the availability of opioid overdose reversal medication without a person-specific prescription. (b) Certain requirement A grant may be made under this section only if the State involved has authorized standing orders regarding opioid overdose reversal medication. (c) Preference in making grants In making grants under this section, the Secretary shall give preference to States that— (1) have not issued standing orders regarding opioid overdose reversal medication; (2) authorize standing orders that permit community-based organizations, substance abuse programs, or other nonprofit entities to acquire, dispense, or administer opioid overdose reversal medication; (3) authorize standing orders that permit police, fire, or emergency medical services agencies to acquire and administer opioid overdose reversal medication; (4) have a higher per capita rate of opioid overdoses than other applicant States; or (5) meet any other criteria deemed appropriate by the Secretary. (d) Grant terms (1) Number A State may not receive more than 1 grant under this section. (2) Period A grant under this section shall be for a period of 3 years. (3) Amount A grant under this section may not exceed $500,000. (4) Limitation A State may use not more than 20 percent of a grant under this section for educating the public pursuant to subsection (a)(5). (e) Applications To be eligible to receive a grant under this section, a State shall submit an application to the Secretary in such form and manner and containing such information as the Secretary may require, including detailed proposed expenditures of grant funds. (f) Reporting Not later than 3 months after the Secretary disburses the first grant payment to any State under this section and every 6 months thereafter for 3 years, such State shall submit a report to the Secretary that includes the following: (1) The name and ZIP Code of each pharmacy in the State that dispenses opioid overdose reversal medication under a standing order. (2) The total number of opioid overdose reversal medication doses dispensed by each such pharmacy, specifying how many were dispensed with or without a person-specific prescription. (3) The number of pharmacists in the State who have participated in training pursuant to subsection (a)(4). (g) Definitions In this section: (1) Opioid overdose reversal medication The term opioid overdose reversal medication means any drug, including naloxone, that— (A) blocks opioids from attaching to, but does not itself activate, opioid receptors; or (B) inhibits the effects of opioids on opioid receptors. (2) Standing order The term standing order means a document prepared by a person authorized to prescribe medication that permits another person to acquire, dispense, or administer medication without a person-specific prescription. (h) Authorization of appropriations (1) In general To carry out this section, there is authorized to be appropriated $10,815,000 for the period of fiscal years 2016 through 2019. (2) Administrative costs Not more than 3 percent of the amounts made available to carry out this section may be used by the Secretary for administrative expenses of carrying out this section. .

tv_txt: IB 114th CONGRESS 2d Session H. R. 4586 IN THE HOUSE OF REPRESENTATIVES AN ACT To amend the Public Health Service Act to authorize grants to States for developing standing orders and educating health care professionals regarding the dispensing of opioid overdose reversal medication without person-specific prescriptions, and for other purposes.

1. Short title This Act may be cited as Lali’s Law . 2. Opioid overdose reversal medication access and education grant programs (a) Technical clarification Effective as if included in the enactment of the Children’s Health Act of 2000 ( Public Law 106–310 ), section 3405(a) of such Act (114 Stat. 1221) is amended by striking Part E of title III and inserting Part E of title III of the Public Health Service Act . (b) Amendment Title III of the Public Health Service Act is amended by inserting after part D of such title ( 42 U.S.C. 254b et seq. ) the following new part E: E Opioid Use Disorder 341. Opioid overdose reversal medication access and education grant programs (a) Grants to States The Secretary may make grants to States for— (1) developing standing orders for pharmacies regarding opioid overdose reversal medication; (2) encouraging pharmacies to dispense opioid overdose reversal medication pursuant to a standing order; (3) implementing best practices for persons authorized to prescribe medication regarding— (A) prescribing opioids for the treatment of chronic pain; (B) co-prescribing opioid overdose reversal medication with opioids; and (C) discussing the purpose and administration of opioid overdose reversal medication with patients; (4) developing or adapting training materials and methods for persons authorized to prescribe or dispense medication to use in educating the public regarding— (A) when and how to administer opioid overdose reversal medication; and (B) steps to be taken after administering opioid overdose reversal medication; and (5) educating the public regarding— (A) the public health benefits of opioid overdose reversal medication; and (B) the availability of opioid overdose reversal medication without a person-specific prescription. (b) Certain requirement A grant may be made under this section only if the State involved has authorized standing orders regarding opioid overdose reversal medication. (c) Preference in making grants In making grants under this section, the Secretary shall give preference to States that— (1) have not issued standing orders regarding opioid overdose reversal medication; (2) authorize standing orders that permit community-based organizations, substance abuse programs, or other nonprofit entities to acquire, dispense, or administer opioid overdose reversal medication; (3) authorize standing orders that permit police, fire, or emergency medical services agencies to acquire and administer opioid overdose reversal medication; (4) have a higher per capita rate of opioid overdoses than other applicant States; or (5) meet any other criteria deemed appropriate by the Secretary. (d) Grant terms (1) Number A State may not receive more than one grant under this section. (2) Period A grant under this section shall be for a period of 3 years. (3) Amount A grant under this section may not exceed $500,000. (4) Limitation A State may use not more than 20 percent of a grant under this section for educating the public pursuant to subsection (a)(5). (e) Applications To be eligible to receive a grant under this section, a State shall submit an application to the Secretary in such form and manner and containing such information as the Secretary may require, including detailed proposed expenditures of grant funds. (f) Reporting Not later than 3 months after the Secretary disburses the first grant payment to any State under this section and every 6 months thereafter for 3 years, such State shall submit a report to the Secretary that includes the following: (1) The name and ZIP Code of each pharmacy in the State that dispenses opioid overdose reversal medication under a standing order. (2) The total number of opioid overdose reversal medication doses dispensed by each such pharmacy, specifying how many were dispensed with or without a person-specific prescription. (3) The number of pharmacists in the State who have participated in training pursuant to subsection (a)(4). (g) Definitions In this section: (1) Opioid overdose reversal medication The term opioid overdose reversal medication means any drug, including naloxone, that— (A) blocks opioids from attaching to, but does not itself activate, opioid receptors; or (B) inhibits the effects of opioids on opioid receptors. (2) Standing order The term standing order means a document prepared by a person authorized to prescribe medication that permits another person to acquire, dispense, or administer medication without a person-specific prescription. (h) Authorization of appropriations (1) In general To carry out this section, there is authorized to be appropriated $5,000,000 for the period of fiscal years 2017 through 2019. (2) Administrative costs Not more than 3 percent of the amounts made available to carry out this section may be used by the Secretary for administrative expenses of carrying out this section. . 3. Cut-Go Compliance Subsection (f) of section 319D of the Public Health Service Act ( 42 U.S.C. 247d–4 ) is amended by inserting before the period at the end the following: (except such dollar amount shall be reduced by $5,000,000 for fiscal year 2017) .

Passed the House of Representatives May 12, 2016. Karen L. Haas, Clerk.

tv_txt: IIB 114th CONGRESS 2d Session H. R. 4586 IN THE SENATE OF THE UNITED STATES May 16, 2016 Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions AN ACT To amend the Public Health Service Act to authorize grants to States for developing standing orders and educating health care professionals regarding the dispensing of opioid overdose reversal medication without person-specific prescriptions, and for other purposes.

1. Short title This Act may be cited as Lali’s Law . 2. Opioid overdose reversal medication access and education grant programs (a) Technical clarification Effective as if included in the enactment of the Children’s Health Act of 2000 ( Public Law 106–310 ), section 3405(a) of such Act (114 Stat. 1221) is amended by striking Part E of title III and inserting Part E of title III of the Public Health Service Act . (b) Amendment Title III of the Public Health Service Act is amended by inserting after part D of such title ( 42 U.S.C. 254b et seq. ) the following new part E: E Opioid Use Disorder 341. Opioid overdose reversal medication access and education grant programs (a) Grants to States The Secretary may make grants to States for— (1) developing standing orders for pharmacies regarding opioid overdose reversal medication; (2) encouraging pharmacies to dispense opioid overdose reversal medication pursuant to a standing order; (3) implementing best practices for persons authorized to prescribe medication regarding— (A) prescribing opioids for the treatment of chronic pain; (B) co-prescribing opioid overdose reversal medication with opioids; and (C) discussing the purpose and administration of opioid overdose reversal medication with patients; (4) developing or adapting training materials and methods for persons authorized to prescribe or dispense medication to use in educating the public regarding— (A) when and how to administer opioid overdose reversal medication; and (B) steps to be taken after administering opioid overdose reversal medication; and (5) educating the public regarding— (A) the public health benefits of opioid overdose reversal medication; and (B) the availability of opioid overdose reversal medication without a person-specific prescription. (b) Certain requirement A grant may be made under this section only if the State involved has authorized standing orders regarding opioid overdose reversal medication. (c) Preference in making grants In making grants under this section, the Secretary shall give preference to States that— (1) have not issued standing orders regarding opioid overdose reversal medication; (2) authorize standing orders that permit community-based organizations, substance abuse programs, or other nonprofit entities to acquire, dispense, or administer opioid overdose reversal medication; (3) authorize standing orders that permit police, fire, or emergency medical services agencies to acquire and administer opioid overdose reversal medication; (4) have a higher per capita rate of opioid overdoses than other applicant States; or (5) meet any other criteria deemed appropriate by the Secretary. (d) Grant terms (1) Number A State may not receive more than one grant under this section. (2) Period A grant under this section shall be for a period of 3 years. (3) Amount A grant under this section may not exceed $500,000. (4) Limitation A State may use not more than 20 percent of a grant under this section for educating the public pursuant to subsection (a)(5). (e) Applications To be eligible to receive a grant under this section, a State shall submit an application to the Secretary in such form and manner and containing such information as the Secretary may require, including detailed proposed expenditures of grant funds. (f) Reporting Not later than 3 months after the Secretary disburses the first grant payment to any State under this section and every 6 months thereafter for 3 years, such State shall submit a report to the Secretary that includes the following: (1) The name and ZIP Code of each pharmacy in the State that dispenses opioid overdose reversal medication under a standing order. (2) The total number of opioid overdose reversal medication doses dispensed by each such pharmacy, specifying how many were dispensed with or without a person-specific prescription. (3) The number of pharmacists in the State who have participated in training pursuant to subsection (a)(4). (g) Definitions In this section: (1) Opioid overdose reversal medication The term opioid overdose reversal medication means any drug, including naloxone, that— (A) blocks opioids from attaching to, but does not itself activate, opioid receptors; or (B) inhibits the effects of opioids on opioid receptors. (2) Standing order The term standing order means a document prepared by a person authorized to prescribe medication that permits another person to acquire, dispense, or administer medication without a person-specific prescription. (h) Authorization of appropriations (1) In general To carry out this section, there is authorized to be appropriated $5,000,000 for the period of fiscal years 2017 through 2019. (2) Administrative costs Not more than 3 percent of the amounts made available to carry out this section may be used by the Secretary for administrative expenses of carrying out this section. . 3. Cut-Go Compliance Subsection (f) of section 319D of the Public Health Service Act ( 42 U.S.C. 247d–4 ) is amended by inserting before the period at the end the following: (except such dollar amount shall be reduced by $5,000,000 for fiscal year 2017) .

Passed the House of Representatives May 12, 2016. Karen L. Haas, Clerk

tv_txt: IB Union Calendar No. 429 114th CONGRESS 2d Session H. R. 4586 [Report No. 114–555] IN THE HOUSE OF REPRESENTATIVES February 23, 2016 Mr. Dold (for himself and Ms. Clark of Massachusetts ) introduced the following bill; which was referred to the Committee on Energy and Commerce May 10, 2016 Additional sponsors: Mrs. Comstock , Mr. McGovern , Mr. Rokita , Mr. Paulsen , Mr. Turner , and Ms. McSally May 10, 2016 Reported with an amendment, committed to the Committee of the Whole House on the State of the Union, and ordered to be printed Strike out all after the enacting clause and insert the part printed in italic For text of introduced bill, see copy of bill as introduced on February 23, 2016 A BILL To amend the Public Health Service Act to authorize grants to States for developing standing orders and educating health care professionals regarding the dispensing of opioid overdose reversal medication without person-specific prescriptions, and for other purposes.

1. Short title This Act may be cited as Lali’s Law . 2. Opioid overdose reversal medication access and education grant programs (a) Technical clarification Effective as if included in the enactment of the Children’s Health Act of 2000 ( Public Law 106–310 ), section 3405(a) of such Act (114 Stat. 1221) is amended by striking Part E of title III and inserting Part E of title III of the Public Health Service Act . (b) Amendment Title III of the Public Health Service Act is amended by inserting after part D of such title ( 42 U.S.C. 254b et seq. ) the following new part E: E Opioid Use Disorder 341. Opioid overdose reversal medication access and education grant programs (a) Grants to States The Secretary may make grants to States for— (1) developing standing orders for pharmacies regarding opioid overdose reversal medication; (2) encouraging pharmacies to dispense opioid overdose reversal medication pursuant to a standing order; (3) implementing best practices for persons authorized to prescribe medication regarding— (A) prescribing opioids for the treatment of chronic pain; (B) co-prescribing opioid overdose reversal medication with opioids; and (C) discussing the purpose and administration of opioid overdose reversal medication with patients; (4) developing or adapting training materials and methods for persons authorized to prescribe or dispense medication to use in educating the public regarding— (A) when and how to administer opioid overdose reversal medication; and (B) steps to be taken after administering opioid overdose reversal medication; and (5) educating the public regarding— (A) the public health benefits of opioid overdose reversal medication; and (B) the availability of opioid overdose reversal medication without a person-specific prescription. (b) Certain requirement A grant may be made under this section only if the State involved has authorized standing orders regarding opioid overdose reversal medication. (c) Preference in making grants In making grants under this section, the Secretary shall give preference to States that— (1) have not issued standing orders regarding opioid overdose reversal medication; (2) authorize standing orders that permit community-based organizations, substance abuse programs, or other nonprofit entities to acquire, dispense, or administer opioid overdose reversal medication; (3) authorize standing orders that permit police, fire, or emergency medical services agencies to acquire and administer opioid overdose reversal medication; (4) have a higher per capita rate of opioid overdoses than other applicant States; or (5) meet any other criteria deemed appropriate by the Secretary. (d) Grant terms (1) Number A State may not receive more than 1 grant under this section. (2) Period A grant under this section shall be for a period of 3 years. (3) Amount A grant under this section may not exceed $500,000. (4) Limitation A State may use not more than 20 percent of a grant under this section for educating the public pursuant to subsection (a)(5). (e) Applications To be eligible to receive a grant under this section, a State shall submit an application to the Secretary in such form and manner and containing such information as the Secretary may require, including detailed proposed expenditures of grant funds. (f) Reporting Not later than 3 months after the Secretary disburses the first grant payment to any State under this section and every 6 months thereafter for 3 years, such State shall submit a report to the Secretary that includes the following: (1) The name and ZIP Code of each pharmacy in the State that dispenses opioid overdose reversal medication under a standing order. (2) The total number of opioid overdose reversal medication doses dispensed by each such pharmacy, specifying how many were dispensed with or without a person-specific prescription. (3) The number of pharmacists in the State who have participated in training pursuant to subsection (a)(4). (g) Definitions In this section: (1) Opioid overdose reversal medication The term opioid overdose reversal medication means any drug, including naloxone, that— (A) blocks opioids from attaching to, but does not itself activate, opioid receptors; or (B) inhibits the effects of opioids on opioid receptors. (2) Standing order The term standing order means a document prepared by a person authorized to prescribe medication that permits another person to acquire, dispense, or administer medication without a person-specific prescription. (h) Authorization of appropriations (1) In general To carry out this section, there is authorized to be appropriated $5,000,000 for the period of fiscal years 2017 through 2019. (2) Administrative costs Not more than 3 percent of the amounts made available to carry out this section may be used by the Secretary for administrative expenses of carrying out this section. . 3. Cut-Go Compliance Subsection (f) of section 319D of the Public Health Service Act ( 42 U.S.C. 247d–4 ) is amended by inserting before the period at the end the following: (except such dollar amount shall be reduced by $5,000,000 for fiscal year 2017) .

May 10, 2016 Reported with an amendment, committed to the Committee of the Whole House on the State of the Union, and ordered to be printed