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Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Federal Firearms Licensee Protection Act of 2023
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 / HR 2620 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions.
Federal Firearms Licensee Protection Act of 2023
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) via HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
2023 · fourth_quarter · 4T
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 / HR 2620 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Source: Senate LDA
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 / HR 2620 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions.
Share the Savings with Seniors Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 / HR 2620 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions.
Share the Savings with Seniors Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 / HR 2620 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions.
HELP Copays Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 19 "Lower Costs, More Cures Act of 2021," all provisions. Issues pertaining to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
HELP Copays Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 / HR 2620 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions.
HELP Copays Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 / HR 2620 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions.
HELP Copays Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 / HR 2620 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 19 "Lower Costs, More Cures Act of 2021," all provisions. Issues pertaining to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
Safe Step Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 / HR 2620 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions.
Safe Step Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 / HR 2620 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions.
Lower Costs, More Cures Act of 2021
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 / HR 2620 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 19 "Lower Costs, More Cures Act of 2021," all provisions. Issues pertaining to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
Lower Costs, More Cures Act of 2021
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 19 "Lower Costs, More Cures Act of 2021," all provisions. Issues pertaining to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
Investor Choice Act of 2021
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 / HR 2620 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 19 "Lower Costs, More Cures Act of 2021," all provisions. Issues pertaining to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
Improving Seniors’ Timely Access to Care Act of 2021
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 / HR 2620 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions.
Improving Seniors’ Timely Access to Care Act of 2021
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 19 "Lower Costs, More Cures Act of 2021," all provisions. Issues pertaining to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
Improving Seniors’ Timely Access to Care Act of 2021
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 / HR 2620 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 19 "Lower Costs, More Cures Act of 2021," all provisions. Issues pertaining to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
Improving Seniors’ Timely Access to Care Act of 2021
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 / HR 2620 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions.
Inflation Reduction Act of 2022
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 19 "Lower Costs, More Cures Act of 2021," all provisions. Issues pertaining to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
Inflation Reduction Act of 2022
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 / HR 2620 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 19 "Lower Costs, More Cures Act of 2021," all provisions. Issues pertaining to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
Accelerated Approval Integrity Act of 2022
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 / HR 2620 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 19 "Lower Costs, More Cures Act of 2021," all provisions. Issues pertaining to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
Accelerated Approval Integrity Act of 2022
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 19 "Lower Costs, More Cures Act of 2021," all provisions. Issues pertaining to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
Moving and Fostering Innovation to Revolutionize Smarter Transportation Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 19 "Lower Costs, More Cures Act of 2021," all provisions. Issues pertaining to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
Moving and Fostering Innovation to Revolutionize Smarter Transportation Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 / HR 2620 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 19 "Lower Costs, More Cures Act of 2021," all provisions. Issues pertaining to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
Lower Costs, More Cures Act of 2021
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S. 464 "Safe Step Act, all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 909 "Prescription Drug Price Relief Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. HR 19 Lower Costs, More Cures Act of 2021, all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 6963 "Accelerated Approval Integrity Act," all provisions.
Lower Costs, More Cures Act of 2021
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act, all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 909 "Prescription Drug Price Relief Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. HR 19 Lower Costs, More Cures Act of 2021, all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
Safe Step Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S. 464 "Safe Step Act, all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 909 "Prescription Drug Price Relief Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. HR 19 Lower Costs, More Cures Act of 2021, all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 6963 "Accelerated Approval Integrity Act," all provisions.
Safe Step Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163 /S 464 "Safe Step Act," all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act of 2022," all provisions relating to drug pricing and taxes. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions. Issues related to the implementation of PL 115-97 (2017) "Tax Cuts and Jobs Act, all provisions.
Safe Step Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act, all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 909 "Prescription Drug Price Relief Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. HR 19 Lower Costs, More Cures Act of 2021, all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
Improving Seniors’ Timely Access to Care Act of 2021
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163 /S 464 "Safe Step Act," all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act of 2022," all provisions relating to drug pricing and taxes. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions. Issues related to the implementation of PL 115-97 (2017) "Tax Cuts and Jobs Act, all provisions.
Improving Seniors’ Timely Access to Care Act of 2021
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to the Healthy Futures Task Force. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act of 2022," all provisions relating to drug pricing and taxes. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions. Issues related to the implementation of PL 115-97 (2017) "Tax Cuts and Jobs Act, all provisions.
Improving Seniors’ Timely Access to Care Act of 2021
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act, all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 909 "Prescription Drug Price Relief Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. HR 19 Lower Costs, More Cures Act of 2021, all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
Reduced Costs and Continued Cures Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163 /S 464 "Safe Step Act," all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act of 2022," all provisions relating to drug pricing and taxes. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions. Issues related to the implementation of PL 115-97 (2017) "Tax Cuts and Jobs Act, all provisions.
Reduced Costs and Continued Cures Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to the Healthy Futures Task Force. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act of 2022," all provisions relating to drug pricing and taxes. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions. Issues related to the implementation of PL 115-97 (2017) "Tax Cuts and Jobs Act, all provisions.
Reduced Costs and Continued Cures Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S. 464 "Safe Step Act, all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 909 "Prescription Drug Price Relief Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. HR 19 Lower Costs, More Cures Act of 2021, all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 6963 "Accelerated Approval Integrity Act," all provisions.
Reduced Costs and Continued Cures Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act, all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 909 "Prescription Drug Price Relief Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. HR 19 Lower Costs, More Cures Act of 2021, all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
Inflation Reduction Act of 2022
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act, all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 909 "Prescription Drug Price Relief Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. HR 19 Lower Costs, More Cures Act of 2021, all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
Inflation Reduction Act of 2022
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to the Healthy Futures Task Force. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act of 2022," all provisions relating to drug pricing and taxes. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions. Issues related to the implementation of PL 115-97 (2017) "Tax Cuts and Jobs Act, all provisions.
Inflation Reduction Act of 2022
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S. 464 "Safe Step Act, all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 909 "Prescription Drug Price Relief Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. HR 19 Lower Costs, More Cures Act of 2021, all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 6963 "Accelerated Approval Integrity Act," all provisions.
Inflation Reduction Act of 2022
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163 /S 464 "Safe Step Act," all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act of 2022," all provisions relating to drug pricing and taxes. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions. Issues related to the implementation of PL 115-97 (2017) "Tax Cuts and Jobs Act, all provisions.
Accelerated Approval Integrity Act of 2022
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act, all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 909 "Prescription Drug Price Relief Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. HR 19 Lower Costs, More Cures Act of 2021, all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
Accelerated Approval Integrity Act of 2022
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163 /S 464 "Safe Step Act," all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act of 2022," all provisions relating to drug pricing and taxes. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions. Issues related to the implementation of PL 115-97 (2017) "Tax Cuts and Jobs Act, all provisions.
Accelerated Approval Integrity Act of 2022
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to the Healthy Futures Task Force. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act of 2022," all provisions relating to drug pricing and taxes. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions. Issues related to the implementation of PL 115-97 (2017) "Tax Cuts and Jobs Act, all provisions.
Accelerated Approval Integrity Act of 2022
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S. 464 "Safe Step Act, all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 909 "Prescription Drug Price Relief Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. HR 19 Lower Costs, More Cures Act of 2021, all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 6963 "Accelerated Approval Integrity Act," all provisions.
Safe Step Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S. 464 "Safe Step Act, all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 909 "Prescription Drug Price Relief Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. HR 19 Lower Costs, More Cures Act of 2021, all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 6963 "Accelerated Approval Integrity Act," all provisions.
Safe Step Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163 /S 464 "Safe Step Act," all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act of 2022," all provisions relating to drug pricing and taxes. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions. Issues related to the implementation of PL 115-97 (2017) "Tax Cuts and Jobs Act, all provisions.
Safe Step Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act, all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 909 "Prescription Drug Price Relief Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. HR 19 Lower Costs, More Cures Act of 2021, all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
Prescription Drug Price Relief Act of 2021
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S. 464 "Safe Step Act, all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 909 "Prescription Drug Price Relief Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. HR 19 Lower Costs, More Cures Act of 2021, all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 6963 "Accelerated Approval Integrity Act," all provisions.
Prescription Drug Price Relief Act of 2021
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act, all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 909 "Prescription Drug Price Relief Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. HR 19 Lower Costs, More Cures Act of 2021, all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031.
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act, all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 909 "Prescription Drug Price Relief Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. HR 19 Lower Costs, More Cures Act of 2021, all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031.
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S. 464 "Safe Step Act, all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 909 "Prescription Drug Price Relief Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. HR 19 Lower Costs, More Cures Act of 2021, all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 6963 "Accelerated Approval Integrity Act," all provisions.
American Rescue Plan Act of 2021
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (CMS-1744-IFC), all provisions relating to infusion at-home. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program (CMS-5531 IFC), all provisions relating to telemedicine. HR 1319 American Rescue Plan Act of 2021, all provisions relating to removal of Medicaid rebate cap provision. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions. S 909 "Prescription Drug Price Relief Act," all provisions. Issues pertaining to the Defense Production Act and the manufacturing of pharmaceutical products.
American Rescue Plan Act of 2021
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (CMS-1744-IFC), all provisions relating to infusion at-home. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program (CMS-5531 IFC), all provisions relating to telemedicine. HR 1319 American Rescue Plan Act of 2021, all provisions relating to removal of Medicaid rebate cap provision. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions. S 909 "Prescription Drug Price Relief Act," all provisions. Issues pertaining to the Defense Production Act and the manufacturing of pharmaceutical products.
Safe Step Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act," all provisions. Issues pertaining to CMS Rule CMS-1751-P, all provisions relating to telehealth flexibilities and social determinants of health. Issues pertaining to Social Determinants of Health (SDOH), including SDOH Caucus Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule "Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions. S909 "Prescription Drug Price Relief Act," all provisions. HR 3684 "Infrastructure Investment and Jobs Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax provisions. HR 5260 "Reduced Costs and Continued Cures Act," all provisions.
Safe Step Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act," all provisions. Issues pertaining to CMS Rule CMS-1751-P, all provisions relating to telehealth flexibilities and social determinants of health. Issues pertaining to Social Determinants of Health (SDOH), including SDOH Caucus Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule "Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions. S909 "Prescription Drug Price Relief Act," all provisions. HR 3684 "Infrastructure Investment and Jobs Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax issues. HR 5260 "Reduced Costs and Continued Cures Act," all provisions.
Infrastructure Investment and Jobs Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act," all provisions. Issues pertaining to CMS Rule CMS-1751-P, all provisions relating to telehealth flexibilities and social determinants of health. Issues pertaining to Social Determinants of Health (SDOH), including SDOH Caucus Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule "Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions. S909 "Prescription Drug Price Relief Act," all provisions. HR 3684 "Infrastructure Investment and Jobs Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax provisions. HR 5260 "Reduced Costs and Continued Cures Act," all provisions.
Infrastructure Investment and Jobs Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act," all provisions. Issues pertaining to CMS Rule CMS-1751-P, all provisions relating to telehealth flexibilities and social determinants of health. Issues pertaining to Social Determinants of Health (SDOH), including SDOH Caucus Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule "Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions. S909 "Prescription Drug Price Relief Act," all provisions. HR 3684 "Infrastructure Investment and Jobs Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax issues. HR 5260 "Reduced Costs and Continued Cures Act," all provisions.
Reduced Costs and Continued Cures Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act," all provisions. Issues pertaining to CMS Rule CMS-1751-P, all provisions relating to telehealth flexibilities and social determinants of health. Issues pertaining to Social Determinants of Health (SDOH), including SDOH Caucus Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule "Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions. S909 "Prescription Drug Price Relief Act," all provisions. HR 3684 "Infrastructure Investment and Jobs Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax issues. HR 5260 "Reduced Costs and Continued Cures Act," all provisions.
Reduced Costs and Continued Cures Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act," all provisions. Issues pertaining to CMS Rule CMS-1751-P, all provisions relating to telehealth flexibilities and social determinants of health. Issues pertaining to Social Determinants of Health (SDOH), including SDOH Caucus Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule "Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions. S909 "Prescription Drug Price Relief Act," all provisions. HR 3684 "Infrastructure Investment and Jobs Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax provisions. HR 5260 "Reduced Costs and Continued Cures Act," all provisions.
Inflation Reduction Act of 2022
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act," all provisions. Issues pertaining to CMS Rule CMS-1751-P, all provisions relating to telehealth flexibilities and social determinants of health. Issues pertaining to Social Determinants of Health (SDOH), including SDOH Caucus Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule "Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions. S909 "Prescription Drug Price Relief Act," all provisions. HR 3684 "Infrastructure Investment and Jobs Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax issues. HR 5260 "Reduced Costs and Continued Cures Act," all provisions.
Inflation Reduction Act of 2022
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act," all provisions. Issues pertaining to CMS Rule CMS-1751-P, all provisions relating to telehealth flexibilities and social determinants of health. Issues pertaining to Social Determinants of Health (SDOH), including SDOH Caucus Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule "Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions. S909 "Prescription Drug Price Relief Act," all provisions. HR 3684 "Infrastructure Investment and Jobs Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax provisions. HR 5260 "Reduced Costs and Continued Cures Act," all provisions.
Safe Step Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act," all provisions. Issues pertaining to CMS Rule CMS-1751-P, all provisions relating to telehealth flexibilities and social determinants of health. Issues pertaining to Social Determinants of Health (SDOH), including SDOH Caucus Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule "Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions. S909 "Prescription Drug Price Relief Act," all provisions. HR 3684 "Infrastructure Investment and Jobs Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax issues. HR 5260 "Reduced Costs and Continued Cures Act," all provisions.
Safe Step Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act," all provisions. Issues pertaining to CMS Rule CMS-1751-P, all provisions relating to telehealth flexibilities and social determinants of health. Issues pertaining to Social Determinants of Health (SDOH), including SDOH Caucus Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule "Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions. S909 "Prescription Drug Price Relief Act," all provisions. HR 3684 "Infrastructure Investment and Jobs Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax provisions. HR 5260 "Reduced Costs and Continued Cures Act," all provisions.
Prescription Drug Price Relief Act of 2021
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (CMS-1744-IFC), all provisions relating to infusion at-home. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program (CMS-5531 IFC), all provisions relating to telemedicine. HR 1319 American Rescue Plan Act of 2021, all provisions relating to removal of Medicaid rebate cap provision. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions. S 909 "Prescription Drug Price Relief Act," all provisions. Issues pertaining to the Defense Production Act and the manufacturing of pharmaceutical products.
Prescription Drug Price Relief Act of 2021
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act," all provisions. Issues pertaining to CMS Rule CMS-1751-P, all provisions relating to telehealth flexibilities and social determinants of health. Issues pertaining to Social Determinants of Health (SDOH), including SDOH Caucus Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule "Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions. S909 "Prescription Drug Price Relief Act," all provisions. HR 3684 "Infrastructure Investment and Jobs Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax issues. HR 5260 "Reduced Costs and Continued Cures Act," all provisions.
Prescription Drug Price Relief Act of 2021
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (CMS-1744-IFC), all provisions relating to infusion at-home. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program (CMS-5531 IFC), all provisions relating to telemedicine. HR 1319 American Rescue Plan Act of 2021, all provisions relating to removal of Medicaid rebate cap provision. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions. S 909 "Prescription Drug Price Relief Act," all provisions. Issues pertaining to the Defense Production Act and the manufacturing of pharmaceutical products.
Prescription Drug Price Relief Act of 2021
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act," all provisions. Issues pertaining to CMS Rule CMS-1751-P, all provisions relating to telehealth flexibilities and social determinants of health. Issues pertaining to Social Determinants of Health (SDOH), including SDOH Caucus Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule "Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions. S909 "Prescription Drug Price Relief Act," all provisions. HR 3684 "Infrastructure Investment and Jobs Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax provisions. HR 5260 "Reduced Costs and Continued Cures Act," all provisions.
A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031.
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act," all provisions. Issues pertaining to CMS Rule CMS-1751-P, all provisions relating to telehealth flexibilities and social determinants of health. Issues pertaining to Social Determinants of Health (SDOH), including SDOH Caucus Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule "Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions. S909 "Prescription Drug Price Relief Act," all provisions. HR 3684 "Infrastructure Investment and Jobs Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax provisions. HR 5260 "Reduced Costs and Continued Cures Act," all provisions.
A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031.
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act," all provisions. Issues pertaining to CMS Rule CMS-1751-P, all provisions relating to telehealth flexibilities and social determinants of health. Issues pertaining to Social Determinants of Health (SDOH), including SDOH Caucus Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule "Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions. S909 "Prescription Drug Price Relief Act," all provisions. HR 3684 "Infrastructure Investment and Jobs Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax issues. HR 5260 "Reduced Costs and Continued Cures Act," all provisions.
Patient Protection and Affordable Care Enhancement Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act," all provisions. Issues pertaining to CMS Rule CMS-1751-P, all provisions relating to telehealth flexibilities and social determinants of health. Issues pertaining to Social Determinants of Health (SDOH), including SDOH Caucus Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule "Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions. S909 "Prescription Drug Price Relief Act," all provisions. HR 3684 "Infrastructure Investment and Jobs Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax provisions. HR 5260 "Reduced Costs and Continued Cures Act," all provisions.
Patient Protection and Affordable Care Enhancement Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (CMS-1744-IFC), all provisions relating to infusion at-home. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program (CMS-5531 IFC), all provisions relating to telemedicine. HR 1319 American Rescue Plan Act of 2021, all provisions relating to removal of Medicaid rebate cap provision. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions. S 909 "Prescription Drug Price Relief Act," all provisions. Issues pertaining to the Defense Production Act and the manufacturing of pharmaceutical products.
Patient Protection and Affordable Care Enhancement Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act," all provisions. Issues pertaining to CMS Rule CMS-1751-P, all provisions relating to telehealth flexibilities and social determinants of health. Issues pertaining to Social Determinants of Health (SDOH), including SDOH Caucus Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule "Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions. S909 "Prescription Drug Price Relief Act," all provisions. HR 3684 "Infrastructure Investment and Jobs Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax issues. HR 5260 "Reduced Costs and Continued Cures Act," all provisions.
Patient Protection and Affordable Care Enhancement Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (CMS-1744-IFC), all provisions relating to infusion at-home. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program (CMS-5531 IFC), all provisions relating to telemedicine. HR 1319 American Rescue Plan Act of 2021, all provisions relating to removal of Medicaid rebate cap provision. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions. S 909 "Prescription Drug Price Relief Act," all provisions. Issues pertaining to the Defense Production Act and the manufacturing of pharmaceutical products.
Patient Protection and Affordable Care Enhancement Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (CMS-1744-IFC), all provisions relating to infusion at-home. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program (CMS-5531 IFC), all provisions relating to telemedicine. HR 4996 Helping MOMS Act of 2020, all provisions relating to Medicaid reforms. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions.
Patient Protection and Affordable Care Enhancement Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Medicare Interim Final Rule Revisions in Response to the COVID-19 Public Health Emergency (CMS-1744-IFC), all provisions relating to infusion at-home. Issues pertaining toMedicare and Medicaid Interim Final Rule Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (CMS-5531 IFC), all provisions relating to telemedicine.
Patient Protection and Affordable Care Enhancement Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (CMS-1744-IFC), all provisions relating to infusion at-home. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program (CMS-5531 IFC), all provisions relating to telemedicine. HR 4996 Helping MOMS Act of 2020, all provisions relating to Medicaid reforms. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions.
Lower Costs, More Cures Act of 2019
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
CMS Rule CMS-1711-P relating to Medicare and Medicaid Programs, "CY 2020 Home Health Prospective Payment System Rate Update, Home Health Value-Based Purchasing Model, Home Health Quality Reporting Requirements, and Home Infusion Therapy Requirements," all provisions. H Res 242 "Affirming the importance of the Orphan Drug Act," all provisions. HR 748 / S 3548 "CARES Act," all provisions pertaining to corporate tax, and CMS home infusion benefits. HR 19 "Lower Costs, More Cures Act of 2019," all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers Act, all provisions. HR 3 "Elijah E. Cummings Lower Drug Costs Now Act," all provisions. Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Importation of Prescription Drugs Proposed Rule, Food and Drug Administration (FDA), [Docket No. FDA-2019-N-5711]. Issues relating to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 1391 "Fair Accountability and Innovative Research Drug Pricing Act of 2019, all provisions. S 474 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. Issues relating to creating a cystinosis disease awareness day on May 7th. S 2543 Prescription Drug Pricing Reduction Act of 2019, all provisions in Amendment #4 Improving Metrics for Price Reporting for Orphan Drugs Act. CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. S 1895 Lower Health Care Costs Act, all provisions.
Prescription Drug STAR Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
CMS Rule CMS-1711-P relating to Medicare and Medicaid Programs, "CY 2020 Home Health Prospective Payment System Rate Update, Home Health Value-Based Purchasing Model, Home Health Quality Reporting Requirements, and Home Infusion Therapy Requirements," all provisions. H Res 242 "Affirming the importance of the Orphan Drug Act," all provisions. HR 748 / S 3548 "CARES Act," all provisions pertaining to corporate tax, and CMS home infusion benefits. HR 19 "Lower Costs, More Cures Act of 2019," all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers Act, all provisions. HR 3 "Elijah E. Cummings Lower Drug Costs Now Act," all provisions. Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Importation of Prescription Drugs Proposed Rule, Food and Drug Administration (FDA), [Docket No. FDA-2019-N-5711]. Issues relating to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 1391 "Fair Accountability and Innovative Research Drug Pricing Act of 2019, all provisions. S 474 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. Issues relating to creating a cystinosis disease awareness day on May 7th. S 2543 Prescription Drug Pricing Reduction Act of 2019, all provisions in Amendment #4 Improving Metrics for Price Reporting for Orphan Drugs Act. CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. S 1895 Lower Health Care Costs Act, all provisions.
More Efficient Tools to Realize Information for Consumers Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
CMS Rule CMS-1711-P relating to Medicare and Medicaid Programs, "CY 2020 Home Health Prospective Payment System Rate Update, Home Health Value-Based Purchasing Model, Home Health Quality Reporting Requirements, and Home Infusion Therapy Requirements," all provisions. H Res 242 "Affirming the importance of the Orphan Drug Act," all provisions. HR 748 / S 3548 "CARES Act," all provisions pertaining to corporate tax, and CMS home infusion benefits. HR 19 "Lower Costs, More Cures Act of 2019," all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers Act, all provisions. HR 3 "Elijah E. Cummings Lower Drug Costs Now Act," all provisions. Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Importation of Prescription Drugs Proposed Rule, Food and Drug Administration (FDA), [Docket No. FDA-2019-N-5711]. Issues relating to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 1391 "Fair Accountability and Innovative Research Drug Pricing Act of 2019, all provisions. S 474 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. Issues relating to creating a cystinosis disease awareness day on May 7th. S 2543 Prescription Drug Pricing Reduction Act of 2019, all provisions in Amendment #4 Improving Metrics for Price Reporting for Orphan Drugs Act. CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. S 1895 Lower Health Care Costs Act, all provisions.
Elijah E. Cummings Lower Drug Costs Now Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
CMS Rule CMS-1711-P relating to Medicare and Medicaid Programs, "CY 2020 Home Health Prospective Payment System Rate Update, Home Health Value-Based Purchasing Model, Home Health Quality Reporting Requirements, and Home Infusion Therapy Requirements," all provisions. H Res 242 "Affirming the importance of the Orphan Drug Act," all provisions. HR 748 / S 3548 "CARES Act," all provisions pertaining to corporate tax, and CMS home infusion benefits. HR 19 "Lower Costs, More Cures Act of 2019," all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers Act, all provisions. HR 3 "Elijah E. Cummings Lower Drug Costs Now Act," all provisions. Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Importation of Prescription Drugs Proposed Rule, Food and Drug Administration (FDA), [Docket No. FDA-2019-N-5711]. Issues relating to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 1391 "Fair Accountability and Innovative Research Drug Pricing Act of 2019, all provisions. S 474 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. Issues relating to creating a cystinosis disease awareness day on May 7th. S 2543 Prescription Drug Pricing Reduction Act of 2019, all provisions in Amendment #4 Improving Metrics for Price Reporting for Orphan Drugs Act. CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. S 1895 Lower Health Care Costs Act, all provisions.
Helping Medicaid Offer Maternity Services Act of 2020
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (CMS-1744-IFC), all provisions relating to infusion at-home. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program (CMS-5531 IFC), all provisions relating to telemedicine. HR 4996 Helping MOMS Act of 2020, all provisions relating to Medicaid reforms. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions.
Helping Medicaid Offer Maternity Services Act of 2020
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues pertaining to drug pricing and reimbursement, transparency and patient access. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (CMS-1744-IFC), all provisions relating to infusion at-home. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program (CMS-5531 IFC), all provisions relating to telemedicine. HR 4996 Helping MOMS Act of 2020, all provisions relating to Medicaid reforms. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions.
CARES Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
CMS Rule CMS-1711-P relating to Medicare and Medicaid Programs, "CY 2020 Home Health Prospective Payment System Rate Update, Home Health Value-Based Purchasing Model, Home Health Quality Reporting Requirements, and Home Infusion Therapy Requirements," all provisions. H Res 242 "Affirming the importance of the Orphan Drug Act," all provisions. HR 748 / S 3548 "CARES Act," all provisions pertaining to corporate tax, and CMS home infusion benefits. HR 19 "Lower Costs, More Cures Act of 2019," all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers Act, all provisions. HR 3 "Elijah E. Cummings Lower Drug Costs Now Act," all provisions. Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Importation of Prescription Drugs Proposed Rule, Food and Drug Administration (FDA), [Docket No. FDA-2019-N-5711]. Issues relating to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 1391 "Fair Accountability and Innovative Research Drug Pricing Act of 2019, all provisions. S 474 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. Issues relating to creating a cystinosis disease awareness day on May 7th. S 2543 Prescription Drug Pricing Reduction Act of 2019, all provisions in Amendment #4 Improving Metrics for Price Reporting for Orphan Drugs Act. CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. S 1895 Lower Health Care Costs Act, all provisions.
Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases.
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
CMS Rule CMS-1711-P relating to Medicare and Medicaid Programs, "CY 2020 Home Health Prospective Payment System Rate Update, Home Health Value-Based Purchasing Model, Home Health Quality Reporting Requirements, and Home Infusion Therapy Requirements," all provisions. H Res 242 "Affirming the importance of the Orphan Drug Act," all provisions. HR 748 / S 3548 "CARES Act," all provisions pertaining to corporate tax, and CMS home infusion benefits. HR 19 "Lower Costs, More Cures Act of 2019," all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers Act, all provisions. HR 3 "Elijah E. Cummings Lower Drug Costs Now Act," all provisions. Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Importation of Prescription Drugs Proposed Rule, Food and Drug Administration (FDA), [Docket No. FDA-2019-N-5711]. Issues relating to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 1391 "Fair Accountability and Innovative Research Drug Pricing Act of 2019, all provisions. S 474 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. Issues relating to creating a cystinosis disease awareness day on May 7th. S 2543 Prescription Drug Pricing Reduction Act of 2019, all provisions in Amendment #4 Improving Metrics for Price Reporting for Orphan Drugs Act. CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. S 1895 Lower Health Care Costs Act, all provisions.
Fair Accountability and Innovative Research Drug Pricing Act of 2019
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
CMS Rule CMS-1711-P relating to Medicare and Medicaid Programs, "CY 2020 Home Health Prospective Payment System Rate Update, Home Health Value-Based Purchasing Model, Home Health Quality Reporting Requirements, and Home Infusion Therapy Requirements," all provisions. H Res 242 "Affirming the importance of the Orphan Drug Act," all provisions. HR 748 / S 3548 "CARES Act," all provisions pertaining to corporate tax, and CMS home infusion benefits. HR 19 "Lower Costs, More Cures Act of 2019," all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers Act, all provisions. HR 3 "Elijah E. Cummings Lower Drug Costs Now Act," all provisions. Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Importation of Prescription Drugs Proposed Rule, Food and Drug Administration (FDA), [Docket No. FDA-2019-N-5711]. Issues relating to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 1391 "Fair Accountability and Innovative Research Drug Pricing Act of 2019, all provisions. S 474 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. Issues relating to creating a cystinosis disease awareness day on May 7th. S 2543 Prescription Drug Pricing Reduction Act of 2019, all provisions in Amendment #4 Improving Metrics for Price Reporting for Orphan Drugs Act. CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. S 1895 Lower Health Care Costs Act, all provisions.
Lower Health Care Costs Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
CMS Rule CMS-1711-P relating to Medicare and Medicaid Programs, "CY 2020 Home Health Prospective Payment System Rate Update, Home Health Value-Based Purchasing Model, Home Health Quality Reporting Requirements, and Home Infusion Therapy Requirements," all provisions. H Res 242 "Affirming the importance of the Orphan Drug Act," all provisions. HR 748 / S 3548 "CARES Act," all provisions pertaining to corporate tax, and CMS home infusion benefits. HR 19 "Lower Costs, More Cures Act of 2019," all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers Act, all provisions. HR 3 "Elijah E. Cummings Lower Drug Costs Now Act," all provisions. Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Importation of Prescription Drugs Proposed Rule, Food and Drug Administration (FDA), [Docket No. FDA-2019-N-5711]. Issues relating to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 1391 "Fair Accountability and Innovative Research Drug Pricing Act of 2019, all provisions. S 474 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. Issues relating to creating a cystinosis disease awareness day on May 7th. S 2543 Prescription Drug Pricing Reduction Act of 2019, all provisions in Amendment #4 Improving Metrics for Price Reporting for Orphan Drugs Act. CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. S 1895 Lower Health Care Costs Act, all provisions.
Prescription Drug Pricing Reduction Act of 2019
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
CMS Rule CMS-1711-P relating to Medicare and Medicaid Programs, "CY 2020 Home Health Prospective Payment System Rate Update, Home Health Value-Based Purchasing Model, Home Health Quality Reporting Requirements, and Home Infusion Therapy Requirements," all provisions. H Res 242 "Affirming the importance of the Orphan Drug Act," all provisions. HR 748 / S 3548 "CARES Act," all provisions pertaining to corporate tax, and CMS home infusion benefits. HR 19 "Lower Costs, More Cures Act of 2019," all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers Act, all provisions. HR 3 "Elijah E. Cummings Lower Drug Costs Now Act," all provisions. Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Importation of Prescription Drugs Proposed Rule, Food and Drug Administration (FDA), [Docket No. FDA-2019-N-5711]. Issues relating to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 1391 "Fair Accountability and Innovative Research Drug Pricing Act of 2019, all provisions. S 474 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. Issues relating to creating a cystinosis disease awareness day on May 7th. S 2543 Prescription Drug Pricing Reduction Act of 2019, all provisions in Amendment #4 Improving Metrics for Price Reporting for Orphan Drugs Act. CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. S 1895 Lower Health Care Costs Act, all provisions.
CARES Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
CMS Rule CMS-1711-P relating to Medicare and Medicaid Programs, "CY 2020 Home Health Prospective Payment System Rate Update, Home Health Value-Based Purchasing Model, Home Health Quality Reporting Requirements, and Home Infusion Therapy Requirements," all provisions. H Res 242 "Affirming the importance of the Orphan Drug Act," all provisions. HR 748 / S 3548 "CARES Act," all provisions pertaining to corporate tax, and CMS home infusion benefits. HR 19 "Lower Costs, More Cures Act of 2019," all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers Act, all provisions. HR 3 "Elijah E. Cummings Lower Drug Costs Now Act," all provisions. Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Importation of Prescription Drugs Proposed Rule, Food and Drug Administration (FDA), [Docket No. FDA-2019-N-5711]. Issues relating to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 1391 "Fair Accountability and Innovative Research Drug Pricing Act of 2019, all provisions. S 474 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. Issues relating to creating a cystinosis disease awareness day on May 7th. S 2543 Prescription Drug Pricing Reduction Act of 2019, all provisions in Amendment #4 Improving Metrics for Price Reporting for Orphan Drugs Act. CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. S 1895 Lower Health Care Costs Act, all provisions.
Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
CMS Rule CMS-1711-P relating to Medicare and Medicaid Programs, "CY 2020 Home Health Prospective Payment System Rate Update, Home Health Value-Based Purchasing Model, Home Health Quality Reporting Requirements, and Home Infusion Therapy Requirements," all provisions. H Res 242 "Affirming the importance of the Orphan Drug Act," all provisions. HR 748 / S 3548 "CARES Act," all provisions pertaining to corporate tax, and CMS home infusion benefits. HR 19 "Lower Costs, More Cures Act of 2019," all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers Act, all provisions. HR 3 "Elijah E. Cummings Lower Drug Costs Now Act," all provisions. Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Importation of Prescription Drugs Proposed Rule, Food and Drug Administration (FDA), [Docket No. FDA-2019-N-5711]. Issues relating to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 1391 "Fair Accountability and Innovative Research Drug Pricing Act of 2019, all provisions. S 474 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. Issues relating to creating a cystinosis disease awareness day on May 7th. S 2543 Prescription Drug Pricing Reduction Act of 2019, all provisions in Amendment #4 Improving Metrics for Price Reporting for Orphan Drugs Act. CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. S 1895 Lower Health Care Costs Act, all provisions.
To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs.
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Regulation CMS-1711-P "CY 2020 Home Health Prospective Payment System Rate Update, Home Health Value-Based Purchasing Model, Home Health Quality Reporting Requirements, and Home Infusion Therapy Requirements," all provisions. Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to drug pricing transparency. HR 2296 FAIR Drug Pricing Act of 2019, all provisions. S 4743 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers (METRIC) Act, all provisions. Issues related to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. H Res 242 Orphan Drug Act, all provisions. HR 1503 "Orange Book Transparency Act of 2019," provisions in Section 2 relating to the Orange Book. HR 107 To amend title XIX of Social Security Act, all provisions. Issues related to creating a cystinosis disease awareness day on May 7th. Office of the Inspector General (HHS) Rule OIG-0936-P relating to Fraud and Abuse, Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, all provisions. CMS Rule CMS-5528-ANPRM relating to Medicare Program, International Pricing Index Model for Medicare Part B Drugs, all provisions. Issues related to importation of pharmaceuticals. S 2543 Prescription Drug Pricing Reduction Act of 2019, all provisions in Amendment #4 Improving Metrics for Price Reporting for Orphan Drugs Act. HR 3 "Lower Drug Costs Now Act of 2019," all provisions. Issues related to the implementation of PL 115-97 (2017) "Tax Cuts and Jobs Act, all provisions. S 1895 Lower Health Care Costs Act, all provisions. HR 259 Medicaid Extenders Act of 2019, all provisions. HR 19 Lower Costs, More Cures Act of 2019, all provisions.
To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs.
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to drug pricing transparency. HR 2296 FAIR Drug Pricing Act of 2019, all provisions. S 4743 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers (METRIC) Act, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. H Res 242 Orphan Drug Act, all provisions. HR 1503 "Orange Book Transparency Act of 2019," provisions in Section 2 relating to the Orange Book. HR 107 To amend title XIX of Social Security Act, all provisions. Issues pertaining to creating a cystinosis disease awareness day on May 7th. Office of the Inspector General (HHS) Rule OIG-0936-P relating to Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees. CMS Rule CMS-5528-ANPRM relating to Medicare Program; International Pricing Index Model for Medicare Part B Drugs. Issues pertaining to importation of pharmaceuticals.
To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs.
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Regulation CMS-1711-P "CY 2020 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; and Home Infusion Therapy Requirements," all provisions. Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to drug pricing transparency. HR 2296 FAIR Drug Pricing Act of 2019, all provisions. S 4743 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers (METRIC) Act, all provisions. Issues related to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. H Res 242 Orphan Drug Act, all provisions. HR 1503 "Orange Book Transparency Act of 2019," provisions in Section 2 relating to the Orange Book. HR 107 To amend title XIX of Social Security Act, all provisions. Issues related to creating a cystinosis disease awareness day on May 7th. Office of the Inspector General (HHS) Rule OIG-0936-P, all provisions pertaining to Fraud and Abuse; Issues related to the removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees. CMS Rule CMS-5528-ANPRM relating to Medicare Program, all provisions. Issues related to an International Pricing Index Model for Medicare Part B Drugs. Issues related to importation of pharmaceuticals. S 102 " Prescription Drug Price Relief Act of 2019," all provisions. HR 3 " Lower Drug Costs Now Act of 2019," all provisions.
Orange Book Transparency Act of 2020
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to drug pricing transparency. HR 2296 FAIR Drug Pricing Act of 2019, all provisions. S 4743 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers (METRIC) Act, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. H Res 242 Orphan Drug Act, all provisions. HR 1503 "Orange Book Transparency Act of 2019," provisions in Section 2 relating to the Orange Book. HR 107 To amend title XIX of Social Security Act, all provisions. Issues pertaining to creating a cystinosis disease awareness day on May 7th. Office of the Inspector General (HHS) Rule OIG-0936-P relating to Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees. CMS Rule CMS-5528-ANPRM relating to Medicare Program; International Pricing Index Model for Medicare Part B Drugs. Issues pertaining to importation of pharmaceuticals.
Orange Book Transparency Act of 2020
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Regulation CMS-1711-P "CY 2020 Home Health Prospective Payment System Rate Update, Home Health Value-Based Purchasing Model, Home Health Quality Reporting Requirements, and Home Infusion Therapy Requirements," all provisions. Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to drug pricing transparency. HR 2296 FAIR Drug Pricing Act of 2019, all provisions. S 4743 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers (METRIC) Act, all provisions. Issues related to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. H Res 242 Orphan Drug Act, all provisions. HR 1503 "Orange Book Transparency Act of 2019," provisions in Section 2 relating to the Orange Book. HR 107 To amend title XIX of Social Security Act, all provisions. Issues related to creating a cystinosis disease awareness day on May 7th. Office of the Inspector General (HHS) Rule OIG-0936-P relating to Fraud and Abuse, Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, all provisions. CMS Rule CMS-5528-ANPRM relating to Medicare Program, International Pricing Index Model for Medicare Part B Drugs, all provisions. Issues related to importation of pharmaceuticals. S 2543 Prescription Drug Pricing Reduction Act of 2019, all provisions in Amendment #4 Improving Metrics for Price Reporting for Orphan Drugs Act. HR 3 "Lower Drug Costs Now Act of 2019," all provisions. Issues related to the implementation of PL 115-97 (2017) "Tax Cuts and Jobs Act, all provisions. S 1895 Lower Health Care Costs Act, all provisions. HR 259 Medicaid Extenders Act of 2019, all provisions. HR 19 Lower Costs, More Cures Act of 2019, all provisions.
Orange Book Transparency Act of 2020
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. HR 1503 "Orange Book Transparency Act of 2019," all provisions. H Res 242 "Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases," all provisions.
Orange Book Transparency Act of 2020
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Regulation CMS-1711-P "CY 2020 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; and Home Infusion Therapy Requirements," all provisions. Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to drug pricing transparency. HR 2296 FAIR Drug Pricing Act of 2019, all provisions. S 4743 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers (METRIC) Act, all provisions. Issues related to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. H Res 242 Orphan Drug Act, all provisions. HR 1503 "Orange Book Transparency Act of 2019," provisions in Section 2 relating to the Orange Book. HR 107 To amend title XIX of Social Security Act, all provisions. Issues related to creating a cystinosis disease awareness day on May 7th. Office of the Inspector General (HHS) Rule OIG-0936-P, all provisions pertaining to Fraud and Abuse; Issues related to the removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees. CMS Rule CMS-5528-ANPRM relating to Medicare Program, all provisions. Issues related to an International Pricing Index Model for Medicare Part B Drugs. Issues related to importation of pharmaceuticals. S 102 " Prescription Drug Price Relief Act of 2019," all provisions. HR 3 " Lower Drug Costs Now Act of 2019," all provisions.
Lower Costs, More Cures Act of 2019
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Regulation CMS-1711-P "CY 2020 Home Health Prospective Payment System Rate Update, Home Health Value-Based Purchasing Model, Home Health Quality Reporting Requirements, and Home Infusion Therapy Requirements," all provisions. Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to drug pricing transparency. HR 2296 FAIR Drug Pricing Act of 2019, all provisions. S 4743 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers (METRIC) Act, all provisions. Issues related to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. H Res 242 Orphan Drug Act, all provisions. HR 1503 "Orange Book Transparency Act of 2019," provisions in Section 2 relating to the Orange Book. HR 107 To amend title XIX of Social Security Act, all provisions. Issues related to creating a cystinosis disease awareness day on May 7th. Office of the Inspector General (HHS) Rule OIG-0936-P relating to Fraud and Abuse, Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, all provisions. CMS Rule CMS-5528-ANPRM relating to Medicare Program, International Pricing Index Model for Medicare Part B Drugs, all provisions. Issues related to importation of pharmaceuticals. S 2543 Prescription Drug Pricing Reduction Act of 2019, all provisions in Amendment #4 Improving Metrics for Price Reporting for Orphan Drugs Act. HR 3 "Lower Drug Costs Now Act of 2019," all provisions. Issues related to the implementation of PL 115-97 (2017) "Tax Cuts and Jobs Act, all provisions. S 1895 Lower Health Care Costs Act, all provisions. HR 259 Medicaid Extenders Act of 2019, all provisions. HR 19 Lower Costs, More Cures Act of 2019, all provisions.
Prescription Drug STAR Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to drug pricing transparency. HR 2296 FAIR Drug Pricing Act of 2019, all provisions. S 4743 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers (METRIC) Act, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. H Res 242 Orphan Drug Act, all provisions. HR 1503 "Orange Book Transparency Act of 2019," provisions in Section 2 relating to the Orange Book. HR 107 To amend title XIX of Social Security Act, all provisions. Issues pertaining to creating a cystinosis disease awareness day on May 7th. Office of the Inspector General (HHS) Rule OIG-0936-P relating to Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees. CMS Rule CMS-5528-ANPRM relating to Medicare Program; International Pricing Index Model for Medicare Part B Drugs. Issues pertaining to importation of pharmaceuticals.
Prescription Drug STAR Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Regulation CMS-1711-P "CY 2020 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; and Home Infusion Therapy Requirements," all provisions. Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to drug pricing transparency. HR 2296 FAIR Drug Pricing Act of 2019, all provisions. S 4743 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers (METRIC) Act, all provisions. Issues related to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. H Res 242 Orphan Drug Act, all provisions. HR 1503 "Orange Book Transparency Act of 2019," provisions in Section 2 relating to the Orange Book. HR 107 To amend title XIX of Social Security Act, all provisions. Issues related to creating a cystinosis disease awareness day on May 7th. Office of the Inspector General (HHS) Rule OIG-0936-P, all provisions pertaining to Fraud and Abuse; Issues related to the removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees. CMS Rule CMS-5528-ANPRM relating to Medicare Program, all provisions. Issues related to an International Pricing Index Model for Medicare Part B Drugs. Issues related to importation of pharmaceuticals. S 102 " Prescription Drug Price Relief Act of 2019," all provisions. HR 3 " Lower Drug Costs Now Act of 2019," all provisions.
Prescription Drug STAR Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Regulation CMS-1711-P "CY 2020 Home Health Prospective Payment System Rate Update, Home Health Value-Based Purchasing Model, Home Health Quality Reporting Requirements, and Home Infusion Therapy Requirements," all provisions. Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to drug pricing transparency. HR 2296 FAIR Drug Pricing Act of 2019, all provisions. S 4743 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers (METRIC) Act, all provisions. Issues related to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. H Res 242 Orphan Drug Act, all provisions. HR 1503 "Orange Book Transparency Act of 2019," provisions in Section 2 relating to the Orange Book. HR 107 To amend title XIX of Social Security Act, all provisions. Issues related to creating a cystinosis disease awareness day on May 7th. Office of the Inspector General (HHS) Rule OIG-0936-P relating to Fraud and Abuse, Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, all provisions. CMS Rule CMS-5528-ANPRM relating to Medicare Program, International Pricing Index Model for Medicare Part B Drugs, all provisions. Issues related to importation of pharmaceuticals. S 2543 Prescription Drug Pricing Reduction Act of 2019, all provisions in Amendment #4 Improving Metrics for Price Reporting for Orphan Drugs Act. HR 3 "Lower Drug Costs Now Act of 2019," all provisions. Issues related to the implementation of PL 115-97 (2017) "Tax Cuts and Jobs Act, all provisions. S 1895 Lower Health Care Costs Act, all provisions. HR 259 Medicaid Extenders Act of 2019, all provisions. HR 19 Lower Costs, More Cures Act of 2019, all provisions.
More Efficient Tools to Realize Information for Consumers Act
Client: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) · Firm: HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
Regulation CMS-1711-P "CY 2020 Home Health Prospective Payment System Rate Update, Home Health Value-Based Purchasing Model, Home Health Quality Reporting Requirements, and Home Infusion Therapy Requirements," all provisions. Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to drug pricing transparency. HR 2296 FAIR Drug Pricing Act of 2019, all provisions. S 4743 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers (METRIC) Act, all provisions. Issues related to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. H Res 242 Orphan Drug Act, all provisions. HR 1503 "Orange Book Transparency Act of 2019," provisions in Section 2 relating to the Orange Book. HR 107 To amend title XIX of Social Security Act, all provisions. Issues related to creating a cystinosis disease awareness day on May 7th. Office of the Inspector General (HHS) Rule OIG-0936-P relating to Fraud and Abuse, Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, all provisions. CMS Rule CMS-5528-ANPRM relating to Medicare Program, International Pricing Index Model for Medicare Part B Drugs, all provisions. Issues related to importation of pharmaceuticals. S 2543 Prescription Drug Pricing Reduction Act of 2019, all provisions in Amendment #4 Improving Metrics for Price Reporting for Orphan Drugs Act. HR 3 "Lower Drug Costs Now Act of 2019," all provisions. Issues related to the implementation of PL 115-97 (2017) "Tax Cuts and Jobs Act, all provisions. S 1895 Lower Health Care Costs Act, all provisions. HR 259 Medicaid Extenders Act of 2019, all provisions. HR 19 Lower Costs, More Cures Act of 2019, all provisions.
2023 · third_quarter · Q3
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 / HR 2620 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions.
Filing targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE
HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) via HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
2023 · second_quarter · Q2
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 / HR 2620 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 19 "Lower Costs, More Cures Act of 2021," all provisions. Issues pertaining to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
Filing targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 19 "Lower Costs, More Cures Act of 2021," all provisions. Issues pertaining to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
Filing targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE
HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) via HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
2022 · fourth_quarter · Q4
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163 /S 464 "Safe Step Act," all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act of 2022," all provisions relating to drug pricing and taxes. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions. Issues related to the implementation of PL 115-97 (2017) "Tax Cuts and Jobs Act, all provisions.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Issues pertaining to the Healthy Futures Task Force. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act of 2022," all provisions relating to drug pricing and taxes. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions. Issues related to the implementation of PL 115-97 (2017) "Tax Cuts and Jobs Act, all provisions.
Filing targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) via HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
2022 · second_quarter · 2A
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act, all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 909 "Prescription Drug Price Relief Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. HR 19 Lower Costs, More Cures Act of 2021, all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S. 464 "Safe Step Act, all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 909 "Prescription Drug Price Relief Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. HR 19 Lower Costs, More Cures Act of 2021, all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 6963 "Accelerated Approval Integrity Act," all provisions.
Filing targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) via HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
2021 · fourth_quarter · Q4
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act," all provisions. Issues pertaining to CMS Rule CMS-1751-P, all provisions relating to telehealth flexibilities and social determinants of health. Issues pertaining to Social Determinants of Health (SDOH), including SDOH Caucus Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule "Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions. S909 "Prescription Drug Price Relief Act," all provisions. HR 3684 "Infrastructure Investment and Jobs Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax provisions. HR 5260 "Reduced Costs and Continued Cures Act," all provisions.
Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act," all provisions. Issues pertaining to CMS Rule CMS-1751-P, all provisions relating to telehealth flexibilities and social determinants of health. Issues pertaining to Social Determinants of Health (SDOH), including SDOH Caucus Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule "Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions. S909 "Prescription Drug Price Relief Act," all provisions. HR 3684 "Infrastructure Investment and Jobs Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax issues. HR 5260 "Reduced Costs and Continued Cures Act," all provisions.
HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) via HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
2021 · second_quarter · Q2
Issues pertaining to drug pricing and reimbursement, transparency and patient access. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (CMS-1744-IFC), all provisions relating to infusion at-home. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program (CMS-5531 IFC), all provisions relating to telemedicine. HR 1319 American Rescue Plan Act of 2021, all provisions relating to removal of Medicaid rebate cap provision. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions. S 909 "Prescription Drug Price Relief Act," all provisions. Issues pertaining to the Defense Production Act and the manufacturing of pharmaceutical products.
Issues pertaining to drug pricing and reimbursement, transparency and patient access. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (CMS-1744-IFC), all provisions relating to infusion at-home. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program (CMS-5531 IFC), all provisions relating to telemedicine. HR 1319 American Rescue Plan Act of 2021, all provisions relating to removal of Medicaid rebate cap provision. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions. S 909 "Prescription Drug Price Relief Act," all provisions. Issues pertaining to the Defense Production Act and the manufacturing of pharmaceutical products.
HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) via HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
2020 · fourth_quarter · Q4
Issues pertaining to drug pricing and reimbursement, transparency and patient access. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. Issues pertaining to CMS-55238-IFC relating to Medicare Program "Most Favored Nations Model," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (CMS-1744-IFC), all provisions relating to infusion at-home. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program (CMS-5531 IFC), all provisions relating to telemedicine. HR 4996 Helping MOMS Act of 2020, all provisions relating to Medicaid reforms. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions.
Issues pertaining to drug pricing and reimbursement, transparency and patient access. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (CMS-1744-IFC), all provisions relating to infusion at-home. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Interim Final Rule Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program (CMS-5531 IFC), all provisions relating to telemedicine. HR 4996 Helping MOMS Act of 2020, all provisions relating to Medicaid reforms. Issues pertaining to Centers for Medicare & Medicaid Services (CMS) Proposed Rule Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Part Liability (TPL) Requirements [Docket No. CMS 2020-0072], all provisions.
HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) via HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
2020 · second_quarter · Q2
Issues pertaining to drug pricing and reimbursement, transparency and patient access. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Food and Drug Administration Proposed Rule, Docket No. FDA-2019-N-5711, Importation of Prescription Drugs, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues pertaining to CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. HR 1425 Patient Protection and Affordable Care Enhancement Act, Title III, Lowering Prices through Fair Drug Price Negotiations, all provisions. Issues pertaining to Medicare Interim Final Rule Revisions in Response to the COVID-19 Public Health Emergency (CMS-1744-IFC), all provisions relating to infusion at-home. Issues pertaining toMedicare and Medicaid Interim Final Rule Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (CMS-5531 IFC), all provisions relating to telemedicine.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
CMS Rule CMS-1711-P relating to Medicare and Medicaid Programs, "CY 2020 Home Health Prospective Payment System Rate Update, Home Health Value-Based Purchasing Model, Home Health Quality Reporting Requirements, and Home Infusion Therapy Requirements," all provisions. H Res 242 "Affirming the importance of the Orphan Drug Act," all provisions. HR 748 / S 3548 "CARES Act," all provisions pertaining to corporate tax, and CMS home infusion benefits. HR 19 "Lower Costs, More Cures Act of 2019," all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers Act, all provisions. HR 3 "Elijah E. Cummings Lower Drug Costs Now Act," all provisions. Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Importation of Prescription Drugs Proposed Rule, Food and Drug Administration (FDA), [Docket No. FDA-2019-N-5711]. Issues relating to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 1391 "Fair Accountability and Innovative Research Drug Pricing Act of 2019, all provisions. S 474 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. Issues relating to creating a cystinosis disease awareness day on May 7th. S 2543 Prescription Drug Pricing Reduction Act of 2019, all provisions in Amendment #4 Improving Metrics for Price Reporting for Orphan Drugs Act. CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. S 1895 Lower Health Care Costs Act, all provisions.
HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) via HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
2019 · fourth_quarter · Q4
Regulation CMS-1711-P "CY 2020 Home Health Prospective Payment System Rate Update, Home Health Value-Based Purchasing Model, Home Health Quality Reporting Requirements, and Home Infusion Therapy Requirements," all provisions. Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to drug pricing transparency. HR 2296 FAIR Drug Pricing Act of 2019, all provisions. S 4743 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers (METRIC) Act, all provisions. Issues related to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. H Res 242 Orphan Drug Act, all provisions. HR 1503 "Orange Book Transparency Act of 2019," provisions in Section 2 relating to the Orange Book. HR 107 To amend title XIX of Social Security Act, all provisions. Issues related to creating a cystinosis disease awareness day on May 7th. Office of the Inspector General (HHS) Rule OIG-0936-P relating to Fraud and Abuse, Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, all provisions. CMS Rule CMS-5528-ANPRM relating to Medicare Program, International Pricing Index Model for Medicare Part B Drugs, all provisions. Issues related to importation of pharmaceuticals. S 2543 Prescription Drug Pricing Reduction Act of 2019, all provisions in Amendment #4 Improving Metrics for Price Reporting for Orphan Drugs Act. HR 3 "Lower Drug Costs Now Act of 2019," all provisions. Issues related to the implementation of PL 115-97 (2017) "Tax Cuts and Jobs Act, all provisions. S 1895 Lower Health Care Costs Act, all provisions. HR 259 Medicaid Extenders Act of 2019, all provisions. HR 19 Lower Costs, More Cures Act of 2019, all provisions.
Regulation CMS-1711-P "CY 2020 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; and Home Infusion Therapy Requirements," all provisions. Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to drug pricing transparency. HR 2296 FAIR Drug Pricing Act of 2019, all provisions. S 4743 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers (METRIC) Act, all provisions. Issues related to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. H Res 242 Orphan Drug Act, all provisions. HR 1503 "Orange Book Transparency Act of 2019," provisions in Section 2 relating to the Orange Book. HR 107 To amend title XIX of Social Security Act, all provisions. Issues related to creating a cystinosis disease awareness day on May 7th. Office of the Inspector General (HHS) Rule OIG-0936-P, all provisions pertaining to Fraud and Abuse; Issues related to the removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees. CMS Rule CMS-5528-ANPRM relating to Medicare Program, all provisions. Issues related to an International Pricing Index Model for Medicare Part B Drugs. Issues related to importation of pharmaceuticals. S 102 " Prescription Drug Price Relief Act of 2019," all provisions. HR 3 " Lower Drug Costs Now Act of 2019," all provisions.
HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) via HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
2019 · second_quarter · Q2
Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to drug pricing transparency. HR 2296 FAIR Drug Pricing Act of 2019, all provisions. S 4743 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers (METRIC) Act, all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. H Res 242 Orphan Drug Act, all provisions. HR 1503 "Orange Book Transparency Act of 2019," provisions in Section 2 relating to the Orange Book. HR 107 To amend title XIX of Social Security Act, all provisions. Issues pertaining to creating a cystinosis disease awareness day on May 7th. Office of the Inspector General (HHS) Rule OIG-0936-P relating to Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees. CMS Rule CMS-5528-ANPRM relating to Medicare Program; International Pricing Index Model for Medicare Part B Drugs. Issues pertaining to importation of pharmaceuticals.
Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. HR 1503 "Orange Book Transparency Act of 2019," all provisions. H Res 242 "Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases," all provisions.
Filing targets: HOUSE OF REPRESENTATIVES, Office of Policy Development, SENATE
HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) via HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
2018 · fourth_quarter · Q4
Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. HR 4710 "340B Protecting Access for the Underserved and Safety-net Entities Act," all provisions. S 2312 "Helping Ensure Low-income Patients have Access to Care and Treatment" (HELP Act), all provisions. S 2453 "Ensuring the Value of the 340B Program Act of 2018," all provisions. HR 5598 "340B Optimization Act," all provisions. HR 6071 "SERV Communities Act," all provisions. HR 6240 "Drug Discount Accountability Act," all provisions.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. HR 4710 "340B Protecting Access for the Underserved and Safety-net Entities Act," all provisions. S 2312 "Helping Ensure Low-income Patients have Access to Care and Treatment" (HELP Act), all provisions. S 2453 "Ensuring the Value of the 340B Program Act of 2018," all provisions. HR 5598 "340B Optimization Act," all provisions. HR 6071 "SERV Communities Act," all provisions. HR 6240 "Drug Discount Accountability Act," all provisions.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.) via HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)
2018 · second_quarter · Q2
Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. HR 4710 "340B Protecting Access for the Underserved and Safety-net Entities Act," all provisions. S 2312 "Helping Ensure Low-income Patients have Access to Care and Treatment" (HELP Act), all provisions. S 2453 "Ensuring the Value of the 340B Program Act of 2018," all provisions. HR 5598 "340B Optimization Act," all provisions. HR 6071 "SERV Communities Act," all provisions. HR 6240 "Drug Discount Accountability Act," all provisions.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. HR 4710 "340B Protecting Access for the Underserved and Safety-net Entities Act," all provisions. S 2312 "Helping Ensure Low-income Patients have Access to Care and Treatment" (HELP Act), all provisions. S 2453 "Ensuring the Value of the 340B Program Act of 2018," all provisions.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of
Filing targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Veterans Affairs, Dept of (VA)
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Filing targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE