THOMAS GILES

340B Program/Transparency; generics access; Clinical Trial Diversity S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S. 2305 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA] S. 148 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Amy Klobuchar (D-MN) S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S. 775, Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R. 9070, Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS] H.R.6094 - Providing Realistic Opportunity To Equal and Comparable Treatment (PROTECT) for Rare Act To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. Sponsor: Rep. Matsui, Doris O. [D-CA-7] S. 142 - Preserve Access to Affordable Generics and Biosimilars Act To prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.2666 - EPCS 2.0 Act To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.7312 - EPCS 2.0 Act To provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Rep. Kuster, Ann M. [D-NH-2] S.4741 - PLASMA Act To amend title XVIII of the Social Security Act to provide a phase-in for plasma-derived products under the manufacturer discount program. Sponsor: Sen. Tillis, Thomas [R-NC] HR 6465 PLASMA Act To amend title XVIII of the Social Security Act to provide a phase-in for plasma-derived products under the manufacturer discount program. Sponsor: Rep. Hudson, Richard [R-NC-9] S. 1067, Ensuring Timely Access to Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] H.R.1359 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Rep. Norcross, Donald [D-NJ-1] S.644 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Sen. Markey, Edward J. [D-MA]

Medicare Advantage & MA Rate Notice S.1378 - Connecting Our Medical Providers with Links to Expand Tailored and Effective Care (COMPLETE Care Act) To amend title XVIII of the Social Security Act to provide incentives for behavioral health integration under the Medicare program. Sponsor: Sen. Cortez Masto, Catherine [D-NV] H.R.5819 - Connecting Our Medical Providers with Links to Expand Tailored and Effective Care Act To amend title XVIII of the Social Security Act to provide incentives for behavioral health integration under the Medicare program. Sponsor: Rep. Steel, Michelle [R-CA-45] H.R. 7149, Equal Access to Specialty Care Everywhere (EASE) Act of 2024 To amend title XI of the Social Security Act to require the Center for Medicare and Medicaid Innovation to test a model to improve access to specialty health services for certain Medicare and Medicaid beneficiaries. Sponsor: Rep. Steel, Michelle [R-CA-45] S.4078 - EASE Act of 2024 To amend title XI of the Social Security Act to require the Center for Medicare and Medicaid Innovation to test a model to improve access to specialty health services for certain Medicare and Medicaid beneficiaries. Sponsor: Sen. Mullin, Markwayne [R-OK] H.R.5746 - Addressing Whole Health in Medicare Advantage Act To amend title XVIII of the Social Security Act to expand the availability of supplemental benefits to certain Medicare Advantage enrollees. Sponsor: Rep. Bilirakis, Gus M. [R-FL-12] H.R. 6860, Restore Protections for Dialysis Patients Act To amend title XVIII of the Social Security Act to clarify and preserve the breadth of the protections under the Medicare Secondary Payer Act. Sponsor: Rep. Kelly, Mike [R-PA-16] H.R. 7623, Telehealth Modernization Act To amend title XVIII of the Social Security Act to make permanent certain telehealth flexibilities under the Medicare program. Sponsor: Rep. Carter, Earl L. "Buddy" [R-GA-1] H.R. 5380 - To amend title XVIII of the Social Security Act to increase data transparency for supplemental benefits under Medicare Advantage. To amend title XVIII of the Social Security Act to increase data transparency for supplemental benefits under Medicare Advantage. Sponsor: Rep. Sarbanes, John P. [D-MD-3] H.R. 5388 - Supporting Innovation for Seniors Act To amend title XVIII of the Social Security Act to provide coverage of certain technologies and medical devices under the Medicare program. Sponsor: Rep. Balderson, Troy [R-OH-12] H.R. 8561 - To amend title XVIII of the Social Security Act to address significant under projection of MA local area growth due to wage index reclassification To amend title XVIII of the Social Security Act to address significant under projection of MA local area growth due to wage index reclassification. Sponsor: Rep. Tenney, Claudia [R-NY-24]

Gene Therapies; Prescription Drug Affordability HR 6094, PROTECT Rare Act, by Rep. Doris Matsui (D-CA). To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition. HR 9070, Affordable Prescriptions for Patients Act of 2024, by Rep. Darrell Issa (R-CA). To amend title 35, United States Code, to prohibit product hopping. S 150, Affordable Prescriptions for Patients Act of 2023, by Sen. John Cornyn (R-TX). To amend the Federal Trade Commission Act to prohibit product hopping. S 775, Increasing Transparency in Generic Drug Applications Act, by Sen. Margaret Hassan (D-NH). To provide for increased transparency in generic drug applications. S 1542, DRUG Act, by Sen. Roger Marshall (R-KS). To improve services provided by pharmacy benefit managers.

Medicare Advantage (MA) HR 4605, Healthy Moms and Babies Act, by Rep. Earl Carter (R-GA). To amend titles XIX and XXI of the Social Security Act to improve maternal health coverage under Medicaid and CHIP. HR 4758, Accelerating Kids Access to Care Act, by Rep. Lori Trahan (D-MA). To amend title XIX of the Social Security Act to streamline enrollment under the Medicaid program of certain providers across State lines. HR 5394, Expanding Remote Monitoring Access Act, by Rep. Troy Balderson (R-OH). To ensure appropriate access to remote monitoring services furnished under the Medicare Program. HR 5746, Addressing Whole Health in Medicare Advantage Act, by Rep. Gus Bilirakis (R-FL). To amend title XVIII of the Social Security Act to expand the availability of supplemental benefits to certain Medicare Advantage enrollees. HR 6860, Restore Protections for Dialysis Patients Act, by Rep. Mike Kelly (R-PA). To amend title XVIII of the Social Security Act to clarify and preserve the breadth of the protections under the Medicare Secondary Payer Act. HR 7149, Equal Access to Specialty Care Everywhere (EASE) Act of 2024, by Rep. Michelle Steel (R-CA). To amend title XI of the Social Security Act to require the Center for Medicare and Medicaid Innovation to test a model to improve access to specialty health services for certain Medicare and Medicaid beneficiaries. HR 7623, Telehealth Modernization Act, by Rep. Earl Carter (R-GA). To amend title XVIII of the Social Security Act to make permanent certain telehealth flexibilities under the Medicare program. HR 7996, Improving CARE for Youth Act, by Rep. Neal Dunn (R-FL). To amend title XIX of the Social Security Act to ensure Medicaid coverage of mental health services and primary care services furnished on the same day. HR 8532, Connected MOM Act, by Rep. Lois Frankel (D-FL). To identify and address barriers to coverage of remote physiologic devices under State Medicaid programs to improve maternal and child health outcomes for pregnant and postpartum women. HR 8702, Improving Seniors Timely Access to Care Act of 2024, by Rep. Mike Kelly (R-PA). To amend title XVIII of the Social Security Act to establish requirements with respect to the use of prior authorization under Medicare Advantage plans.

Generics Access; Cell and Gene Therapy; Step Therapy HR 6094, PROTECT Rare Act, by Rep. Doris Matsui (D-CA). To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. HR 7312, EPCS 2.0 Act, by Rep. Ann Kuster (D-NH). To provide requirements for electronic prescribing for controlled substances under group health plans and group and individual health insurance coverage. S 127, Pharmacy Benefit Manager Transparency Act of 2023, by Sen. Maria Cantwell (D-WA). To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. S 142, Preserve Access to Affordable Generics and Biosimilars Act, by Sen. Amy Klobuchar (D-MN). A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. S 148, Stop STALLING Act, by Sen. Amy Klobuchar (D-MN). A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. S 150, Affordable Prescriptions for Patients Act of 2023, by Sen. John Cornyn (R-TX). To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. S 1114, Expanding Access to Low-Cost Generics Act, by Sen. Tina Smith (D-MN). To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. S 1339, Pharmacy Benefit Manager Reform Act, by Sen. Bernie Sanders (I-VT). To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. S 1542, DRUG Act, by Sen. Roger Marshall (R-KS). To improve services provided by pharmacy benefit managers. S 2305, Biosimilar Red Tape Elimination Act, by Sen. Mike Lee (R-UT). To improve the requirements for making a determination of interchangeability of a biological product and its reference product. S 2666, EPCS 2.0 Act, by Sen. Margaret Wood Hassan (D-NH). To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage.

Medicare Advantage (MA) & MA Rate Notice; 340B Program/Transparency HR 2880, Protecting Patients Against PBM Abuses Act, by Rep. Earl Carter (R-GA). To amend title XVIII of the Social Security Act to establish certain requirements for pharmacy benefit managers under Part D of the Medicare program. HR 5380, by Rep. John Sarbanes (D-MD). To amend title XVIII of the Social Security Act to increase data transparency for supplemental benefits under Medicare Advantage. HR 5385, Medicare PBM Accountability Act, by Rep. Greg Landsman (D-OH). To amend title XVIII of the Social Security Act to establish pharmacy benefit manager reporting requirements with respect to prescription drug plans and MA-PD plans under Medicare Part D. HR 5386, Cutting Copays Act, by Rep. Morgan McGarvey (D-KY). To amend title XVIII of the Social Security Act to provide for adjustments to the Medicare Part D cost-sharing reductions for low-income individuals. HR 5388, Supporting Innovation for Seniors Act, by Rep. Troy Balderson (R-OH). To amend title XVIII of the Social Security Act to provide coverage of certain technologies and medical devices under the Medicare program. HR 5663, ALS Better Care Act, by Rep. Janice Schakowsky (D-IL). To amend title XVIII of the Social Security Act to provide coverage of ALS-related services under the Medicare program for individuals diagnosed with amyotrophic lateral sclerosis. HR 5746, Addressing Whole Health in Medicare Advantage Act, by Rep. Gus Bilirakis (R-FL). To amend title XVIII of the Social Security Act to expand the availability of supplemental benefits to certain Medicare Advantage enrollees. HR 6860, Restore Protections for Dialysis Patients Act, by Rep. Mike Kelly (R-PA). To amend title XVIII of the Social Security Act to clarify and preserve the breadth of the protections under the Medicare Secondary Payer Act. HR 7623, Telehealth Modernization Act, by Rep. Earl Carter (R-GA). To amend title XVIII of the Social Security Act to make permanent certain telehealth flexibilities under the Medicare program. HR 7996, Improving CARE for Youth Act, by Rep. Neal Dunn (R-FL). To amend title XIX of the Social Security Act to ensure Medicaid coverage of mental health services and primary care services furnished on the same day. HR 8561, by Rep. Claudia Tenney (R-NY). To amend title XVIII of the Social Security Act to address significant under projection of MA local area growth due to wage index reclassification. S 1378, Connecting Our Medical Providers with Links to Expand Tailored and Effective Care (COMPLETE Care Act), by Sen. Catherine Cortez Masto (D-NV). To amend title XVIII of the Social Security Act to provide incentives for behavioral health integration under the Medicare program.

GUIDEWELL MUTUAL HOLDING CORPORATION

GUIDEWELL MUTUAL HOLDING CORPORATION

GUIDEWELL MUTUAL HOLDING CORPORATION

GUIDEWELL MUTUAL HOLDING CORPORATION