Access to Genetic Counselor Services Act of 2023

H.R.3876/ S.2323 - Access to Genetic Counselor Services Act of 2023

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Living Donor Protection Act (H.R. 2923 / S. 1384) Chronic Kidney Disease Improvement in Research and Treatment Act of 2023 (H.R. 5027/S.4469) Honor Our Living Donors Act (H.R. 6020) Medigap Expansion Act Restore Protections for Dialysis Patients Act (H.R. 6860, S.5081) Expressing support for the designation of the last Tuesday of April each year as "APOL1-Mediated Kidney Disease (AMKD) Awareness Day" (H.Res.1124) Kidney Patient Access to Technologically Innovative and Essential Nephrology Treatments Act of 2023 (H.R. 5074, S. 4510) PASTEUR Act (H.R. 2940/S. 1355) Appropriations-NIH, NIDDK, Kidney Research The New Era for Preventing End-Stage Kidney Disease Act of 2023 The Access to Genetic Counselor Services Act of 2023 (H.R. 3876/S. 2323) The CARING for Social Determinants Act of 2023 (H.R. 1066) End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model

Client expense: $140,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

ALS Better Care Act (H.R 5663/S.3258) - Discussion around supplemental payment to designated ALS clinics that provide multidisciplinary services to people living with ALS. HELP Copays Act (H.R.830 / S.1375) -- Provisions related to health insurance plans requirement to apply payments made by or on behalf of plan enrollees toward a plan's cost-sharing requirements, i.e. a ban on copay-accumulator adjust programs. Access to Genetic Counselor Services Act of 2023 (H.R.3876) - Provisions related to modernization of Medicare to keep pace with generic and genomic medicine innovation. Improves the ability for practitioners to refer patients to genetic counselors, Provides 85% reimbursement of physicians fee schedule amount for service. Discussion around Telehealth permanence (no bill number) - provisions related to permanent telehealth services in Medicare and interstate telehealth services. Close the Medigap Act (HR 35) -Discussion around Medigap guarantee issue provisions for people living with ALS aged under 65. Alleviating Barriers for Caregivers (ABC) Act (S.3109/H.R.8018) - All provisions. Connecting Caregivers to Medicare Act of 2024 (H.R. 7274/S. 3766) - All provisions

Client expense: $30,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related FDA regulation of laboratory tests H.R. 2407, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act S. 2085, the Medicare Multi-Cancer Early Detection Screening Coverage Act Finn Sawyer Access to Cancer Testing Act (H.R. 1780 / S. 642) Access to Genetic Counselor Services Act (H.R. 3876 / S. 2323)

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Healthcare issues related to clinical laboratories; H.R. 2377/S. 1000, the Saving Access to Laboratory Services Act (SALSA), and a draft bill for inflation updates to the Medicare Clinical Laboratory Fee Schedule, provisions relating to reform of Medicare reimbursement for clinical laboratory services under Section 216 of the Protecting Access to Medicare Act, Pub. L. 113-93; H.R. 2369, the Verifying Accurate Leading-edge IVCT Development (VALID) Act, provisions relating to FDA oversight of laboratory-developed tests, and other Federal policy relating to FDA oversight of laboratory-developed tests; H.R. 8702/S. 4518, the Improving Seniors Timely Access to Care Act, provisions relating to prior authorization of services to Medicare Advantage beneficiaries, and other Federal policy relating to prior authorization of services to Medicare Advantage beneficiaries; H.R. 3876/ S. 2323, the Access to Genetic Counselor Services Act, provisions relating to Medicare coverage of genetic counselor services; A draft of the Correct Coding Improvement Act, provisions related to laboratory procedure coding edits adopted by CMS under the National Correct Coding Initiative (NCCI), the adoption of Proprietary Laboratory Analysis (PLA) codes, and access to mandatory code sets for administrative transactions; Federal policy related to Medicare reimbursement for clinical laboratory tests for Alzheimers disease; Federal policy related to value-based care safe harbors under the federal anti-kickback statute; Federal policy related to supply chain issues affecting pre-clinical biomedical research for drug development; and Federal policy related to the frequency of U.S. Preventive Services Task Force updates to colorectal cancer screening guidelines.

Client expense: $240,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support Medicare Multi-Cancer Early Detection Screening Coverage Act (HR 2407/ S 2085) Support Reducing Hereditary Cancer Act (HR 1526/S 765) Support Finn Sawyer Access to Cancer Testing Act (HR 1780/S 642) Support Equitable Community Access to Pharmacist Services Act (HR 1770) Support Find It Early Act (HR 3086) Support Access to Genetic Counselor Services Act HR 3876/S. 2323

Client expense: $460,000 · Firm income: Not reported

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

Support Medicare Multi-Cancer Early Detection Screening Coverage Act (HR 2407/ S 2085) Support Reducing Hereditary Cancer Act (HR 1526/S 765) Support Finn Sawyer Access to Cancer Testing Act (HR 1780/S 642) Support Equitable Community Access to Pharmacist Services Act (HR 1770) Support Find It Early Act (HR 3086) Support Access to Genetic Counselor Services Act HR 3876/S. 2323

Client expense: $420,000 · Firm income: Not reported

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

H.R. 3876/S. 2323 Access to Genetic Counselor Services Act.

Client expense: Not reported · Firm income: Not reported

H.R. 3876/S. 2323 Access to Genetic Counselor Services Act.

Client expense: Not reported · Firm income: Not reported

Issues related FDA regulation of laboratory tests H.R. 2407, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act S. 2085, the Medicare Multi-Cancer Early Detection Screening Coverage Act Finn Sawyer Access to Cancer Testing Act (H.R. 1780 / S. 642) Access to Genetic Counselor Services Act (H.R. 3876 / S. 2323)

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1526/S. 765 -Reducing Hereditary Cancer Act of 2023; bill provides for Medicare coverage of germline mutation testing for individuals with a personal or family history of a hereditary cancer gene mutation or suspected history of hereditary cancer, as well as for associated coverage of risk-reducing surgeries and screenings H.R. 1780/S. 642 - Finn Sawyer Access to Cancer Testing Act; bill provides for coverage of certain cancer diagnostic and laboratory tests under Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). Specifically, the bill provides for coverage of microarray analysis, DNA and RNA sequencing, whole-exome sequencing, and other next-generation sequencing for individuals diagnosed with cancer. H.R. 2407/S. 2085 - Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; bill allows for Medicare coverage and payment for multi-cancer early detection screening tests that are approved by the Food and Drug Administration and that are used to screen for cancer across many cancer types, if the Centers for Medicare & Medicaid Services determines such coverage is appropriate. H.R. 3086 - Find It Early Act; a bill to provide for health coverage with no cost-sharing for additional breast screenings for certain individuals at greater risk for breast cancer. H.R. 4189/S. 2016 - Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2023; a bill to amend title XVIII of the Social Security Act to expand access to telehealth services, and for other purposes. H.R. 3876/S .2323 - Access to Genetic Counselor Services Act of 2023; This bill provides for coverage under Medicare of genetic counseling services that are furnished by genetic counselors. Covered services include those services, as well as incidental services and supplies, that would otherwise be covered under Medicare if provided by a physician. H.R.8702/S.4532 - Improving Seniors Timely Access to Care Act - a bill to establish an electronic prior authorization standard to streamline approvals, reduce the amount of time a health plan is allowed to consider a prior authorization request, require MA plans to report on their use of prior authorization and the rate of approvals and denials, and encourage MA plans to adopt policies that adhere to evidence-based guidelines. H.R. 1770/S. 2477 - Equitable Community Access to Pharmacist Services Act ; would ensure Medicare beneficiaries receive prompt care and services from pharmacists to prevent, diagnose, and treat common infectious diseases. S. 3892 - Community Health Worker Access Act; a bill to amend titles XVIII and XIX of the Social Security Act to increase access to community health workers under the Medicare and Medicaid programs. Women's Health and Cancer Rights Act (WHCRA) - a federal law that provides protections to patients who choose to have breast reconstruction in connection with a mastectomy. Medicare coverage policy for breast cancer treatments and services Proposed waivers under Sections 1115 and 1332 of the Social Security Act; policies related to work requirements, reinsurance and block grants in Medicaid Medicaid unwinding and the process for redetermination of Medicaid eligibility Policies related to the imposition of work requirements within the Medicaid program Policies related to PBM reform Policies related to the implementation of the Inflation Reduction Act Comments in response to Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs, including the Hospital Inpatient Quality Reporting Program; Health and Safety Standards for Obstetrical Services in Hospitals and Critical Access Hospitals; Prior Authorization; Requests for Information; Medicaid and CHIP Continuous Eligibility; Medicaid Clinic Services Four Walls Exceptions; Individuals Currently or Formerly in Custody of Penal Authorities; Revision to Medicare Special Enrollment Period for Formerly Incarcerated Individuals; and All-Inclusive Rate Add-On Payment for High-Cost Drugs Provided by Indian Health Service and Tribal Facilities (CMS-1809-P, RIN 0938-AV35)

Client expense: $100,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of, White House Office

Amending Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169; Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169); e-labeling - allowing FDA to finalize a rule to allow digital versions of prescriptions; Value-based payment arrangements; CMMI; CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure; Efforts to improve coding, coverage, and access for rare disease therapies; Medicaid Drug Rebate Program proposed rule, specifically the stacking rule; Medicare patient access to rare disease therapies, Part B and Part D drugs; Centers for Medicare and Medicaid Innovation (CMMI) policy issues; Center for Medicare and Medicaid Innovation models; General issues related to diagnostic reimbursement; H.R. 5539/S. 3131 Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act; HR1503/S2916 Prescription Information Modernization Act; H.R. 3876 Access to Genetic Counselor Services Act of 2023; H.R. 2666 Medicaid VBPs for Patients Act.

Client expense: $650,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, White House Office

Living Donor Protection Act (H.R. 2923 / S. 1384) Chronic Kidney Disease Improvement in Research and Treatment Act of 2023 (H.R. 5027/S.4469) Honor Our Living Donors Act (H.R. 6020) Medigap Expansion Act Restore Protections for Dialysis Patients Act (H.R. 6860, S.5081) Expressing support for the designation of the last Tuesday of April each year as "APOL1-Mediated Kidney Disease (AMKD) Awareness Day" (H.Res.1124) Kidney Patient Access to Technologically Innovative and Essential Nephrology Treatments Act of 2023 (H.R. 5074, S. 4510) PASTEUR Act (H.R. 2940/S. 1355) Appropriations-NIH, NIDDK, Kidney Research The New Era for Preventing End-Stage Kidney Disease Act of 2023 The Access to Genetic Counselor Services Act of 2023 (H.R. 3876/S. 2323) The CARING for Social Determinants Act of 2023 (H.R. 1066) End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model

Client expense: $185,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Enhance Medicare beneficiary access to genetic counseling services and advocacy on coverage of services furnished by genetic counselors under Medicare Part B. Advocate for H.R. 3876, and S. 2323, the Access to Genetic Counselor Services Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

ALS Better Care Act (H.R 5663/S.3258) - Discussion around supplemental payment to designated ALS clinics that provide multidisciplinary services to people living with ALS. HELP Copays Act (H.R.830 / S.1375) -- Provisions related to health insurance plans requirement to apply payments made by or on behalf of plan enrollees toward a plan's cost-sharing requirements, i.e. a ban on copay-accumulator adjust programs. Access to Genetic Counselor Services Act of 2023 (H.R.3876) - Provisions related to modernization of Medicare to keep pace with generic and genomic medicine innovation. Improves the ability for practitioners to refer patients to genetic counselors, Provides 85% reimbursement of physicians fee schedule amount for service. Discussion around Telehealth permanence (no bill number) - provisions related to permanent telehealth services in Medicare and interstate telehealth services. Close the Medigap Act (HR 35) -Discussion around Medigap guarantee issue provisions for people living with ALS aged under 65. Alleviating Barriers for Caregivers (ABC) Act (S.3109/H.R.8018) - All provisions. Connecting Caregivers to Medicare Act of 2024 (H.R. 7274/S. 3766) - All provisions

Client expense: $30,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support for H.R. 3876/S. 2323, the Access to Genetic Counselor Services Act

Client expense: Not reported · Firm income: $60,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Support for H.R. 3876/S. 2323, the Access to Genetic Counselor Services Act

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3633 - PREVENT HPV H.R. 4286 - Increasing Access to Lung Cancer Screening Act HR 6693 - Lung Cancer Screening and Prevention Act H.R. 9565 - Comprehensive Cancer Survivorship Act H.R. 3876 - Access to Genetic Counselor Services Act H.R. 5378 - Lower Costs, More Transparency Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1526/S. 765 -Reducing Hereditary Cancer Act of 2023; bill provides for Medicare coverage of germline mutation testing for individuals with a personal or family history of a hereditary cancer gene mutation or suspected history of hereditary cancer, as well as for associated coverage of risk-reducing surgeries and screenings H.R. 1780/S. 642 - Finn Sawyer Access to Cancer Testing Act; bill provides for coverage of certain cancer diagnostic and laboratory tests under Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). Specifically, the bill provides for coverage of microarray analysis, DNA and RNA sequencing, whole-exome sequencing, and other next-generation sequencing for individuals diagnosed with cancer. H.R. 2407/S. 2085 - Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; bill allows for Medicare coverage and payment for multi-cancer early detection screening tests that are approved by the Food and Drug Administration and that are used to screen for cancer across many cancer types, if the Centers for Medicare & Medicaid Services determines such coverage is appropriate. H.R. 3086 - Find It Early Act; a bill to provide for health coverage with no cost-sharing for additional breast screenings for certain individuals at greater risk for breast cancer. H.R. 4189/S. 2016 - Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2023; a bill to amend title XVIII of the Social Security Act to expand access to telehealth services, and for other purposes. H.R. 3876/S .2323 - Access to Genetic Counselor Services Act of 2023; This bill provides for coverage under Medicare of genetic counseling services that are furnished by genetic counselors. Covered services include those services, as well as incidental services and supplies, that would otherwise be covered under Medicare if provided by a physician. H.R.8702/S.4532 - Improving Seniors Timely Access to Care Act - a bill to establish an electronic prior authorization standard to streamline approvals, reduce the amount of time a health plan is allowed to consider a prior authorization request, require MA plans to report on their use of prior authorization and the rate of approvals and denials, and encourage MA plans to adopt policies that adhere to evidence-based guidelines. H.R. 1770/S. 2477 - Equitable Community Access to Pharmacist Services Act ; would ensure Medicare beneficiaries receive prompt care and services from pharmacists to prevent, diagnose, and treat common infectious diseases. S. 3892 - Community Health Worker Access Act; a bill to amend titles XVIII and XIX of the Social Security Act to increase access to community health workers under the Medicare and Medicaid programs. Women's Health and Cancer Rights Act (WHCRA) - a federal law that provides protections to patients who choose to have breast reconstruction in connection with a mastectomy. Medicare coverage policy for breast cancer treatments and services Proposed waivers under Sections 1115 and 1332 of the Social Security Act; policies related to work requirements, reinsurance and block grants in Medicaid Medicaid unwinding and the process for redetermination of Medicaid eligibility Policies related to the imposition of work requirements within the Medicaid program Policies related to PBM reform Policies related to the implementation of the Inflation Reduction Act Comments in response to RFI: Medicare Program: Request for Information on Medicare Advantage Data (CMS-4207-NC)

Client expense: $70,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of, White House Office

ALS Better Care Act (H.R 5663/S.3258) - Discussion around supplemental payment to designated ALS clinics that provide multidisciplinary services to people living with ALS. HELP Copays Act (H.R.830 / S.1375) -- Provisions related to health insurance plans requirement to apply payments made by or on behalf of plan enrollees toward a plan's cost-sharing requirements, i.e. a ban on copay-accumulator adjust programs. Access to Genetic Counselor Services Act of 2023 (H.R.3876) - Provisions related to modernization of Medicare to keep pace with generic and genomic medicine innovation. Improves the ability for practitioners to refer patients to genetic counselors, Provides 85% reimbursement of physicians fee schedule amount for service. Discussion around Telehealth permanence (no bill number) - provisions related to permanent telehealth services in Medicare and interstate telehealth services. Close the Medigap Act (HR 35) -Discussion around Medigap guarantee issue provisions for people living with ALS aged under 65.

Client expense: $25,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related FDA regulation of laboratory tests H.R. 2407, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act S. 2085, the Medicare Multi-Cancer Early Detection Screening Coverage Act Finn Sawyer Access to Cancer Testing Act (H.R. 1780 / S. 642) Access to Genetic Counselor Services Act (H.R. 3876 / S. 2323)

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Metastatic Breast Cancer Access to Care Act (S. 663 / HR 549) Reducing Hereditary Cancer Act (HR 1526/S. 765) CONNECT for Health Act (H.R. 4189/S. 2016) Medicare coverage policy for breast cancer treatments and services Telehealth Policies related to funding, state incentives, and federal efforts for Medicaid expansion Issues related to 1115 and 1332 of the Social Security Act; policies related to work requirements, reinsurance and block grants in Medicaid Policies related to Medicare coverage for pharmacy services Medicare coverage policy for drugs and drug pricing H.R. 9505 - Find It Early Act; a bill to provide for health coverage with no cost-sharing for additional breast screenings for certain individuals Medicaid unwinding, the process for redetermination of Medicaid eligibility Medicare Drug Pricing Negotiation implementation Implementation of Lymphedema Treatment Act Preserving and expanding access to Medicaid Policy related to medical billing for breast reconstruction surgery called DIEP flap, a type of natural tissue breast reconstruction that uses non-breast tissue to replace breast tissue Community Health Worker Access Act which is a bill to amend titles XVIII and XIX of the Social Security Act to increase access to community health workers under the Medicare and Medicaid programs (S. 3892) Equitable Community Access to Pharmacist Services Act (S. 2477/H.R. 1770) Access to Genetic Counselor Services Act (H.R.3876/S.2323) Comments Re: Medicaid; CMS Enforcement of State Compliance with Reporting and Federal Medicaid Renewal Requirements Under Section 1902(t) of the Social Security Act (CMS-2447-IFC) Comments RE: Notice of Benefit and Payment Parameters for 2025 Proposed Rule (CMS-9895-P). Comments RE: Request for Information on Medicare Advantage Data

Client expense: Not reported · Firm income: $40,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

H.R. 5539/S. 3131 Orphan Cures Act, (amdending orphan drug exclusion in IRA) H.R. 3876 Access to Genetic Counselor Services Act of 2023 H.R. 2666 Medicaid VBPs for Patients Act Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169) Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169 CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure Medicaid Drug Rebate Program Proposed Rule Centers for Medicare and Medicaid Innovation (CMMI) policy issues Value-based payment arrangements Medicare patient access to rare disease therapies, Part B and Part D drugs Medicaid Drug Rebate Program proposed rule, specifically the stacking rule Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies General issues related to diagnostic reimbursement Efforts to improve coding, coverage, and access for rare disease therapies

Client expense: $950,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Support for H.R. 3876/S. 2323, the Access to Genetic Counselor Services Act

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support for H.R. 3876/S. 2323, the Access to Genetic Counselor Services Act

Client expense: Not reported · Firm income: $60,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Enhance Medicare beneficiary access to genetic counseling services and advocacy on coverage of services furnished by genetic counselors under Medicare Part B. Advocate for H.R. 3876, and S. 2323, the Access to Genetic Counselor Services Act.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Living Donor Protection Act (H.R. 2923 / S. 1384) Chronic Kidney Disease Improvement in Research and Treatment Act of 2023 (H.R. 5027/S.4469) Honor Our Living Donors Act (H.R. 6020) Medigap Expansion Act Restore Protections for Dialysis Patients Act (H.R. 6860) Expressing support for the designation of the last Tuesday of April each year as "APOL1-Mediated Kidney Disease (AMKD) Awareness Day" (H.Res.1124) Kidney Patient Access to Technologically Innovative and Essential Nephrology Treatments Act of 2023 (H.R. 5074, S. 4510) PASTEUR Act (H.R. 2940/S. 1355) Appropriations-NIH, NIDDK, Kidney Research The New Era for Preventing End-Stage Kidney Disease Act of 2023 The Access to Genetic Counselor Services Act of 2023 (H.R. 3876/S. 2323) The CARING for Social Determinants Act of 2023 (H.R. 1066) End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model

Client expense: $240,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 3633 - PREVENT HPV H.R. 4286 - Increasing Access to Lung Cancer Screening Act HR 6693 - Lung Cancer Screening and Prevention Act H.R. 9565 - Comprehensive Cancer Survivorship Act H.R. 3876 - Access to Genetic Counselor Services Act H.R. 5378 - Lower Costs, More Transparency Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Living Donor Protection Act (H.R. 2923 / S. 1384) Medigap Expansion Act CARE for All Kidneys Act PASTEUR Act (H.R. 2940/S. 1355) Appropriations-NIH, NIDDK, Kidney Research The Chronic Kidney Disease Improvement in Research and Treatment Act of 2023 (H.R. 5027) The New Era for Preventing End-Stage Kidney Disease Act of 2023 The Access to Genetic Counselor Services Act of 2023 (H.R. 3876/S. 2323) The Long COVID RECOVERY NOW Act (H.R. 1114) The CARING for Social Determinants Act of 2023 (H.R. 1066) End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods; Proposed Rule Medicaid Program; Ensuring Access to Medicaid Services; Proposed Rule

Client expense: $250,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

ALS Better Care Act (H.R 5663/S.3258) - Discussion around supplemental payment to designated ALS clinics that provide multidisciplinary services to people living with ALS. HELP Copays Act (H.R.830 / S.1375) -- Provisions related to health insurance plans requirement to apply payments made by or on behalf of plan enrollees toward a plan's cost-sharing requirements, i.e. a ban on copay-accumulator adjust programs. Access to Genetic Counselor Services Act of 2023 (H.R.3876) - Provisions related to modernization of Medicare to keep pace with generic and genomic medicine innovation. Improves the ability for practitioners to refer patients to genetic counselors, Provides 85% reimbursement of physicians fee schedule amount for service. Discussion around Telehealth permanence (no bill number) - provisions related to permanent telehealth services in Medicare and interstate telehealth services. Close the Medigap Act (HR 35) -Discussion around Medigap guarantee issue provisions for people living with ALS aged under 65.

Client expense: $25,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 549/S. 663 -Metastatic Breast Cancer Access to Care Act; a bill to exempt individuals with metastatic breast cancer from certain waiting periods for disability insurance benefits under the Old-Age, Survivors, and Disability Insurance program and related Medicare coverage H.R. 1526/S. 765 -Reducing Hereditary Cancer Act of 2023; bill provides for Medicare coverage of germline mutation testing for individuals with a personal or family history of a hereditary cancer gene mutation or suspected history of hereditary cancer, as well as for associated coverage of risk-reducing surgeries and screenings H.R. 1780/S. 642 - Finn Sawyer Access to Cancer Testing Act; bill provides for coverage of certain cancer diagnostic and laboratory tests under Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). Specifically, the bill provides for coverage of microarray analysis, DNA and RNA sequencing, whole-exome sequencing, and other next-generation sequencing for individuals diagnosed with cancer. H.R. 2407/S. 2085 - Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; bill allows for Medicare coverage and payment for multi-cancer early detection screening tests that are approved by the Food and Drug Administration and that are used to screen for cancer across many cancer types, if the Centers for Medicare & Medicaid Services determines such coverage is appropriate. H.R. 3086 - Find It Early Act; a bill to provide for health coverage with no cost-sharing for additional breast screenings for certain individuals at greater risk for breast cancer. H.R. 4189/S. 2016 - Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2023; a bill to amend title XVIII of the Social Security Act to expand access to telehealth services, and for other purposes. H.R. 1770/S. 2477 - Equitable Community Access to Pharmacist Services Act ; would ensure Medicare beneficiaries receive prompt care and services from pharmacists to prevent, diagnose, and treat common infectious diseases. S. 3892 - Community Health Worker Access Act; a bill to amend titles XVIII and XIX of the Social Security Act to increase access to community health workers under the Medicare and Medicaid programs. H.R. 3876/S .2323 - Access to Genetic Counselor Services Act of 2023; This bill provides for coverage under Medicare of genetic counseling services that are furnished by genetic counselors. Covered services include those services, as well as incidental services and supplies, that would otherwise be covered under Medicare if provided by a physician. Comments Related to OIG Solicitation New and Modified Safe Harbors and Special Fraud Alerts OIG-1123-N, 88 Fed. Reg. 84116 requesting permission for sponsors of clinical trials targeting cancer or other life-threatening diseases or conditions to cover certain indirect costs incurred by clinical trial participants. Comments Related to CMS Enforcement of State Compliance with Reporting and Federal Medicaid Renewal Requirements Under Section 1902(t) of the Social Security Act (CMS-2447-IFC) Comments related to processes for assessing compliance with Mental Health Parity and Addition Equity in Medicaid and CHIP Comments related to Advance Notice of Methodological Changes for Calendar Year (CY) 2025 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies Comments RE: Medicare Prescription Payment Plan: Draft Part Two Guidance on Select Topics, Implementation of Section 1860D-2 of the Social Security Act for 2025 Medicare coverage policy for breast cancer treatments and services Proposed waivers under Sections 1115 and 1332 of the Social Security Act; policies related to work requirements, reinsurance and block grants in Medicaid Medicaid unwinding and the process for redetermination of Medicaid eligibility Policies related to the imposition of work requirements within the Medicaid program Policies related to PBM reform Policy related to medical billing for breast reconstruction surgery called DIEP flap, a type of natural tissue breast reconstruction that uses non-breast tissue to replace breast tissue Policies related to the implementation of the Inflation Reduction Act Policies related to the implementation of the Lymphedema Treatment Act

Client expense: $70,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of, White House Office

Issues related FDA regulation of laboratory tests H.R. 2407, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act S. 2085, the Medicare Multi-Cancer Early Detection Screening Coverage Act Finn Sawyer Access to Cancer Testing Act (H.R. 1780 / S. 642) Access to Genetic Counselor Services Act (H.R. 3876 / S. 2323)

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support Medicare Multi-Cancer Early Detection Screening Coverage Act (HR 2407/ S 2085) Support Reducing Hereditary Cancer Act (HR 1526/S 765) Support Finn Sawyer Access to Cancer Testing Act (HR 1780/S 642) Support Equitable Community Access to Pharmacist Services Act (HR 1770) Support Find It Early Act (HR 3086) Support Access to Genetic Counselor Services Act HR 3876/S. 2323

Client expense: $390,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Metastatic Breast Cancer Access to Care Act (S. 663 / HR 549) Reducing Hereditary Cancer Act (HR 1526/S. 765) CONNECT for Health Act (H.R. 4189/S. 2016) Medicare coverage policy for breast cancer treatments and services Telehealth Policies related to funding, state incentives, and federal efforts for Medicaid expansion Issues related to 1115 and 1332 of the Social Security Act; policies related to work requirements, reinsurance and block grants in Medicaid Policies related to Medicare coverage for pharmacy services Medicare coverage policy for drugs and drug pricing H.R. 9505 - Find It Early Act; a bill to provide for health coverage with no cost-sharing for additional breast screenings for certain individuals Medicaid unwinding, the process for redetermination of Medicaid eligibility Medicare Drug Pricing Negotiation implementation Implementation of Lymphedema Treatment Act Preserving and expanding access to Medicaid Comments on Processes for Assessing Compliance with Mental Health Parity and Addiction Equity in Medicaid and CHIP Policy related to medical billing for breast reconstruction surgery called DIEP flap, a type of natural tissue breast reconstruction that uses non-breast tissue to replace breast tissue Community Health Worker Access Act which is a bill to amend titles XVIII and XIX of the Social Security Act to increase access to community health workers under the Medicare and Medicaid programs (S. 3892) Equitable Community Access to Pharmacist Services Act (S. 2477/H.R. 1770) Access to Genetic Counselor Services Act (H.R.3876/S.2323) Comments Re: Medicaid; CMS Enforcement of State Compliance with Reporting and Federal Medicaid Renewal Requirements Under Section 1902(t) of the Social Security Act (CMS-2447-IFC) Comments RE: Notice of Benefit and Payment Parameters for 2025 Proposed Rule (CMS-9895-P). Comments RE OIG Solicitation New and Modified Safe Harbors and Special Fraud Alerts OIG-1123-N, 88 Fed. Reg. 84116 requesting permission for sponsors of clinical trials targeting cancer or other life-threatening diseases or conditions to cover certain indirect costs incurred by clinical trial participants. Comments RE: Medicare Prescription Payment Plan: Draft Part Two Guidance on Select Topics, Implementation of Section 1860D-2 of the Social Security Act for 2025

Client expense: Not reported · Firm income: $40,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

H.R. 5539 Orphan Cures Act, (expanding orphan drug exclusion in IRA) H.R. 3876 Access to Genetic Counselor Services Act of 2023 H.R. 2666 Medicaid VBPs for Patients Act H.R. 5539 Orphan Cures Act, (expanding orphan drug exclusion in IRA) Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169) Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169 CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure Centers for Medicare and Medicaid Innovation (CMMI) policy issues Value-based payment arrangements Medicare patient access to rare disease therapies, Part B and Part D drugs Medicaid Drug Rebate Program proposed rule, specifically the stacking rule Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies General issues related to diagnostic reimbursement Value-based payment arrangements Efforts to improve coding, coverage, and access for rare disease therapies

Client expense: $700,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support for H.R. 3876/S. 2323, the Access to Genetic Counselor Services Act

Client expense: Not reported · Firm income: $60,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Support for H.R. 3876/S. 2323, the Access to Genetic Counselor Services Act

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Enhance Medicare beneficiary access to genetic counseling services and advocacy on coverage of services furnished by genetic counselors under Medicare Part B. Advocate for H.R. 3876, and S. 2323, the Access to Genetic Counselor Services Act.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3633 - PREVENT HPV H.R. 4286 - Increasing Access to Lung Cancer Screening Act HR 6693 - Lung Cancer Screening and Prevention Act H.R. 9565 - Comprehensive Cancer Survivorship Act H.R. 3876 - Access to Genetic Counselor Services Act H.R. 5378 - Lower Costs, More Transparency Act

Client expense: $110,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Living Donor Protection Act (H.R. 2923 / S. 1384) Medigap Expansion Act CARE for All Kidneys Act PASTEUR Act (H.R. 2940/S. 1355) Appropriations-NIH, NIDDK, Kidney Research The Chronic Kidney Disease Improvement in Research and Treatment Act of 2023 (H.R. 5027) The New Era for Preventing End-Stage Kidney Disease Act of 2023 The Access to Genetic Counselor Services Act of 2023 (H.R. 3876/S. 2323) The Long COVID RECOVERY NOW Act (H.R. 1114) The CARING for Social Determinants Act of 2023 (H.R. 1066) End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods; Proposed Rule Medicaid Program; Ensuring Access to Medicaid Services; Proposed Rule

Client expense: $140,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169) Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169 CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure Centers for Medicare and Medicaid Innovation (CMMI) policy issues Medicare patient access to rare disease therapies, Part B and Part D drugs Medicaid Drug Rebate Program proposed rule, specifically the stacking rule Value-based payment arrangements Efforts to improve coding, coverage, and access for rare disease therapies General issues related to diagnostic reimbursement H.R. 3876 Access to Genetic Counselor Services Act of 2023 H.R. 2666 Medicaid VBPs for Patients Act H.R. 5539 Orphan Cures Act, (expanding orphan drug exclusion in IRA) H.R.5378/S. 3430, the LOWER COSTS, MORE TRANSPARENCY ACT, In Senate - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act (Better Act), S. 1339, Pharmacy Benefit Manager Reform Act

Client expense: $830,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, White House Office

Issues related FDA regulation of laboratory tests H.R. 2407, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act S. 2085, the Medicare Multi-Cancer Early Detection Screening Coverage Act Finn Sawyer Access to Cancer Testing Act (H.R. 1780 / S. 642) Access to Genetic Counselor Services Act (H.R. 3876 / S. 2323)

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support for H.R. 3876/S. 2323, the Access to Genetic Counselor Services Act

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support for H.R. 3876/S. 2323, the Access to Genetic Counselor Services Act

Client expense: Not reported · Firm income: $60,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE