Childhood Cancer STAR Reauthorization Act of 2022

Issues related to health insurance, including Medicare, Medicaid and short term plans. Issues related to prescription drug costs and affordability. Issues related to the No Surprises Act and patient protections. Issues related to agency funding for medical and cancer research. Issues related to H.R. 3089/S. 1544, the Accelerating Kids' Access to Care Act and H.R. 7630/S.4120, the Childhood Cancer STAR Reauthorization Act. Issues related to clinical trial diversity including H.R. 5030/S.2706, DIVERSE Trials Act, in H.R. 6584, DEPICT Act.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S 464/HR 2163 Safe Step Act - implementing safe guards around step therapy (fail first) programs in ERISA regulated plans HR 1550 - PREVENT HPV Cancers Act of 2021 HR 3258 - TACT Act of 2021- improve patient access to anti-cancer oral medications HR 4385/S 3080- Cancer Drug Parity Act of 2021- oral parity HR 5801- HELP Copays Act- copay accumulator programs S 3039/HR 2503- Social Determinants Accelerator Act of 2021- SDOH HR 5030/S 2706- DIVERSE Trials Act- access to clinical trials HR 6584- DEPICT Act- access to clinical trials HR 6000- Cures 2.0 HR 5963/S 3611- Provider Relief Fund Improvement Act- extends deadlines, expands the uses of, and makes other changes pertaining to the Provider Relief Fund HR 4450/S 2352- Access to Infertility Treatment and Care Act- requires private insurance to cover fertility preservation services ARPA-H FDA User Fee Agreement policy riders: increasing diversity in clinical trials, improvements to accelerated approval pathway, expanded use of real world data, and in vitro clinical tests HR 7630/S 4120- Childhood Cancer STAR Reauthorization Act of 2022- reauthorizes the STAR Act through FY2028 S 4293- Pharmacy Benefit Manager Transparency Act of 2022- prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs S 4430- Interagency Patent Coordination and Improvement Act of 2022- establishes an interagency taskforce between the United States Patent and Trademark Office and the FDA S 5295/HR 9565- Comprehensive Cancer Survivorship Act- addresses the health of cancer survivors and unmet needs that survivors face through the entire continuum of care from diagnosis through active treatment and posttreatment HR 4128/S 2209- VALID Act of 2021- requires FDA to regulate in vitro clinical tests

Funding for the National Institutes of Health The Childhood Cancer STAR Reauthorization Act (S.4120/H.R.7630)

Client expense: Not reported · Firm income: $37,500

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 7630 / S 4120, Childhood Cancer STAR Reauthorization Act; HR 3773 / S 1357, the Pediatricians Accelerate Childhood Therapies (PACT) Act; HR 623, the Gabriella Miller Kids First Act

Client expense: $120,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

HR 5776, the Build Back Better Act; HR 4385 / S 3080, the Cancer Drug Parity Act; HR 5030 / S 2706, the Diverse Trials Act; HR 7630 / 4120, Childhood Cancer STAR Reauthorization Act; HR 5416, the Give Kids a Chance Act; HR 6584, the DEPICT Act; HR 7512, the Protecting Patients from Deceptive Health Plans Act; HR 7667, the Food and Drug Amendments Act; specifically Title V; HR 8845, the NIH Clinical Trial Diversity Act; HR 8324, the Health Share Transparency Act; S 4185, the RARE Act; S 4348, the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act; S 4294, Pharmacy Benefit Manager Transparency Act of 2022; HR 6833, the FY2023 Continuing Appropriations and Ukraine Supplemental Appropriations Act, specifically provisions related to FDA user fees; FDA regulations regarding sites of delivery for clinical trial services; federal regulation of Short Term Limited Duration Insurance and other non-ACA compliant insurance plans; implementation of the No Surprises Act (enacted in the 116th Congress); Consumer Assistance Programs; 2024 Notice of Benefit and Payment Parameters regulation

Client expense: $120,000 · Firm income: Not reported

S 464/HR 2163 Safe Step Act - implementing safe guards around step therapy (fail first) programs in ERISA regulated plans HR 1550 - PREVENT HPV Cancers Act of 2021 HR 3258 - TACT Act of 2021- improve patient access to anti-cancer oral medications HR 4385/S 3080- Cancer Drug Parity Act of 2021- oral parity HR 5801- HELP Copays Act- copay accumulator programs S 3039/HR 2503- Social Determinants Accelerator Act of 2021- SDOH HR 5030/S 2706- DIVERSE Trials Act- access to clinical trials HR 6584- DEPICT Act- access to clinical trials HR 6000- Cures 2.0 HR 5963/S 3611- Provider Relief Fund Improvement Act- extends deadlines, expands the uses of, and makes other changes pertaining to the Provider Relief Fund HR 4450/S 2352- Access to Infertility Treatment and Care Act- requires private insurance to cover fertility preservation services ARPA-H FDA User Fee Agreement policy riders: increasing diversity in clinical trials, improvements to accelerated approval pathway, expanded use of real world data, and in vitro clinical tests HR 7630/S 4120- Childhood Cancer STAR Reauthorization Act of 2022- reauthorizes the STAR Act through FY2028 S 4293- Pharmacy Benefit Manager Transparency Act of 2022- prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs S 4430- Interagency Patent Coordination and Improvement Act of 2022- establishes an interagency taskforce between the United States Patent and Trademark Office and the FDA

Client expense: $125,406 · Firm income: Not reported

Legislation involving survivorship coverage; PDUFA childhood cancer issues; LHHS and FDA appropriations; Childhood Cancer STAR Reauthorization Act, S. 4120/HR 7630.

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 7630 / S 4120, Childhood Cancer STAR Reauthorization Act; HR 3773 / S 1357, the Pediatricians Accelerate Childhood Therapies (PACT) Act; HR 623, the Gabriella Miller Kids First Act

Client expense: $170,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 5776, the Build Back Better Act; HR 4385 / S 3080, the Cancer Drug Parity Act; HR 5030 / S 2706, the Diverse Trials Act; HR 7630 / 4120, Childhood Cancer STAR Reauthorization Act; HR 5416, the Give Kids a Chance Act; HR 6584, the DEPICT Act; HR 7512, the Protecting Patients from Deceptive Health Plans Act; HR 7667, the Food and Drug Amendments Act; specifically Title V; HR 8845, the NIH Clinical Trial Diversity Act; HR 8324, the Health Share Transparency Act; S 4185, the RARE Act; S 4348, the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act; S 4294, Pharmacy Benefit Manager Transparency Act of 2022; FDA regulations regarding sites of delivery for clinical trial services; federal regulation of Short Term Limited Duration Insurance and other non-ACA compliant insurance plans; implementation of the No Surprises Act (enacted in the 116th Congress); Consumer Assistance Programs;

Client expense: $170,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Funding for the National Institutes of Health The Childhood Cancer STAR Reauthorization Act (S.4120/H.R.7630)

Client expense: Not reported · Firm income: $37,500

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation involving survivorship coverage; PDUFA childhood cancer issues; LHHS and FDA appropriations; Childhood Cancer STAR Reauthorization Act, S. 4120/HR 7630.

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE