VALID Act of 2023

Issues related to MDUFA implementation; FDA staffing Issues relating to the medical product supply chain Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to HR 3723 - the Medical Device Electronic Labeling Act Issues related to PFAS and EtO Chemical regulation Issues related to the Valid Act of 2023 - H.R. 2369 Issues related to cyber security Issues related to consumer and health data privacy Issues related to regulation and reimbursement of artificial intelligence in healthcare Issues related to FDA's third party review program

Client expense: $300,000 · Firm income: Not reported

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

Matters pertaining to the VALID Act of 2023 (H.R.2369)

Client expense: Not reported · Firm income: Not reported

Issues impacting diagnostics including FDA regulation of laboratory developed tests; H.R.2369, VALID Act of 2023

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues impacting diagnostics including FDA regulation of laboratory developed tests; H.R.2369, VALID Act of 2023

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Matters pertaining to the VALID Act of 2023 (H.R.2369)

Client expense: Not reported · Firm income: Not reported

Matters pertaining to the VALID Act of 2023 (H.R.2369); Provisions that negatively impact Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory businesses; Docket No. FDA-2023-N-2177 (FDA's release of the Final Rule on LDTs

Client expense: Not reported · Firm income: Not reported

No bill #: legislation to clarify CLIA H.R.2369 - VALID Act of 2023 FDA Final Rule: Laboratory Developed Tests S.J.Res.82 - A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Food and Drug Administration relating to "Medical Devices; Laboratory Developed Tests"

Client expense: Not reported · Firm income: $70,500

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislative and regulatory proposals and policies regarding medical device innovation. H.R. 2369, Verifying Accurate, Leading-edge IVCT Development (VALID) Act of 2023. H.R. 1691, Ensuring Patient Access to Critical Breakthrough Products Act of 2023. S. 4638, National Defense Authorization Act for FY2025, provisions regarding medical device innovation.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2369: VALID Act of 2023; provisions related to the the Food and Drug Administration's Laboratory Developed Tests (LDT) Rule and regulation of diagnostics and lab developed tests H.R. 2407: Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; provisions related to coverage of Multi-Cancer Early Detection (MCED) tests General discussions related to the Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization General discussions related to Cures 2.0

Client expense: $400,000 · Firm income: Not reported

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; 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 supply chain issues affecting pre-clinical biomedical research for drug development

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Federal policy and programs regarding oncology research and development related to cancer screening, diagnosis, and survivorship H.R. 9849 - Medical Laboratory Personnel Shortage Relief Act of 2024 H.R. 3248 - Diagnostic Lab Testing Transparency Act H.R. 5378 - Lower Costs, More Transparency Act H.R. 2369 - the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2023 H.R. 88188 - American Privacy Rights Act of 2024 Food and Drug Administration (FDA) policies related to diagnostics and laboratory regulation CMS policies related to Medicare Advantage Engagement with executive branch departments/agencies regarding influenza A (H5) "Avian Flu"

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

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

- Diagnostic regulatory reforms, including the Verifying Accurate Leading-edge IVCT Development Act of 2023 (H.R.2369) and the pilot program for Oncology Drug Products Used with Certain In Vitro Diagnostic Tests

Client expense: $80,000 · Firm income: Not reported

Monitor the following: Project ECHO H.R.2369, To amend the Federal Food, Drug, and Cosmetic Act with respect to in vitro clinical tests, and for other, generally

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

Discussions related to H.R.8078, Sepsis Harm and Cost Reduction Act Discussions regarding H.R.2369, VALID Act of 2023 (Verifying Accurate Leading-edge IVCT Development Act) Discussions regarding H.R.2940, PASTEUR Act (Pioneering Antimicrobial Subscriptions To End Upsurging Resistance Act of 2023) Discussions related to H.R.2377, SALSA Act (Saving Access to Laboratory Services Act)

Client expense: $190,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2369: Verifying Accurate Leading-edge IVCT Development (VALID) Act; all provisions of the bill. H.R. 2377/S. 1000: Saving Access for Laboratory Services (SALSA) Act; all provisions of the bill. Draft Pandemic and All-Hazards Preparedness Reauthorization. Clinical trials infrastructure. General discussions regarding diagnostic reimbursement policies. FDA Final Rule on Laboratory Developed Tests (LDTs). H.R. 7085 BIOSECURE Act; all provisions of the bill.

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

Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

Monitor the following: FDA, Laboratory Developed Tests Rule Cellular Transplant related issues and initiatives Government shutdown disruption, Transplant courier issues H.R.2369, VALID Act of 2023, Laboratory developed issues

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

Monitor the following: H.R.8412, Clinical Trials Modernization Act, generally FDA laboratory developed test rule H.R.2369, VALID Act, generally H.R.7418, To amend the Internal Revenue Code of 1986 to exclude from gross income certain compensation to clinical trial participants, Critical trial issues H.R.9029/S.4942, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2025, Facilities and Administration issues Public Law 118-159, Servicemember Quality of Life Improvement and National Defense Authorization Act for Fiscal Year 2025, Health issues CLIA modernization

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

Issues impacting diagnostics including FDA regulation of laboratory developed tests; H.R.2369, the VALID Act of 2023; S. 1000/H.R. 2377, the Saving Access to Laboratory Services Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues impacting diagnostics including FDA regulation of laboratory developed tests; H.R.2369, VALID Act of 2023.

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General education to advance policies that support innovation in the medical device industry. Issues related to coverage and reimbursement of diagnostic tests, including H.R.2369 the VALID Act of 2023. Issues related to FDA regulation of medical devices. Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices. Issues related to PFAS Chemical regulation. Policy issues related to the regulation of artificial intelligence for medical technology. Legislative initiatives that could impact supply chain for medical technology.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to drug pricing, pharmacies, provider status, biosimilars, cell and gene therapy, behavioral health; Equitable Community Access to Pharmacist Services Act (H.R. 1770 / S. 2477); VALID Act (H.R. 2369); Issues related to Medicare provider cuts and provider reimbursement; Hospital Inpatient Services Modernization Act (H.R.8260); Telehealth Modernization Act of 2024 (H.R. 7623); Cybersecurity in healthcare; Issues related to cybersecurity attacks and the effects on pharmacy

Client expense: $500,000 · 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 Privacy Legislation Issues related to the medical supply chain Issues related to the competitiveness of the medtech industry and the impact of Federal Policies Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to coverage and reimbursement of diagnostic tests VALID Act of 2023 - H.R. 2369. Issues related to Health Equity Issues related to Public Health Emergency Preparedness (including Pandemic All Hazards Preparedness Act reauthorization) Issues related to the use of Artificial Intelligence Issues related to MDUFA Reauthorization Issues related to PFAS Chemical regulation HR 3723 - the Medical Device Electronic Labeling Act HR 5662/S 2907 - the Medical Device Recall Improvement Act S 2672 - Improving Development and Distribution of Diagnostic Tests Act HR 3795 - Diagnostic Testing Preparedness Plan Reimbursement and coverage of focused ultrasound technology Issues related to FDAs third party review program

Client expense: $940,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

HR2389/S1302 - Resident Physician Shortage Reduction Act S2333 - Public Health Workforce Loan Repayment Act Health Workforce Resilience Act S665/HR 4942 Conrad 30 and Physician Access Reauthorization Act CLIA Waiver CURES 2.0 To prevent across-the-board direct spending cuts Cytotechnologist labor rates Remote digital telepathology S 1000/HR 2377 SALSA HR 977 - legislation that would repeal provisions prohibiting self-referrals to new or expanded POHs. HR 1202/S 704 - REDI Act HR2761/S 705 - SPARC Act HR 2764/S1229 - Green New Deal for Health HR 3248 - Diagnostic Lab Testing Transparency Act H.R. 3561, the Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act of 2023 Student loan repayment for FPs HR 4527 - HEALTH DATA Act Primary Care and Health Workforce Expansion Act S 1994 Counting Veterans Cancer Act HR 4875 Doctors in our Borders Act HR 2474 - Strengthening Medicare for Patients and Providers Act Continuing Appropriations Act, 2024 and Other Extensions Act Further Continuing Appropriations and Other Extensions Act, 2024 HR 6683 - Preserving Seniors Access to Physicians Act of 2023 Gene Therapy Precision Medicine Answers for Kids Today Act S.3018/H.R.3173 the Improving Seniors Timely Access to Care Act of 2021 Dr. Lorna Breen Health Care Provider Protection Act PREVAIL HR 6371 - budget neutrality bill EDUCATE Act - Murphy DEI Bill HR 2369 - VALID Act FDA final rule on LDTs Pandemic All-Hazards Preparedness Act H.R.9747, the Continuing Appropriations and Extensions Act, 2025 S.2140/H.R. 9474, the Patent Eligibility Restoration Act of 2023 S.1451 / H.R. 3120 - Healthy Competition for Better Care Act H.R. 9572 - Enhanced Enforcement of Health Coverage Act H.R. 6025/S. 3211 - Healthcare Workforce Resilience Act Cures 2.1 H.R. 10073, Medicare patient Access and Practice Stabilization Act of 2024 S. 4935, Physician Fee Stabilization Act H.R. 5392, The Timely Access to Coverage Decisions Act of 2023 Medical Lab Personnel Shortage Relief Act H.R. 9572 Enhanced Enforcement of Health Coverage Act Sickle Cell Disease Comprehensive Care Act

Client expense: $126,566 · Firm income: Not reported

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

Issues related to MDUFA implementation Issues relating to the medical product supply chain Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to PFAS and EtO Chemical regulation Issues related to the Valid Act of 2023 - H.R. 2369 Issues related to cyber security Issues related to Public Health Emergency Preparedness Issues related to consumer and health data privacy Issues related to regulation and reimbursement of artificial intelligence in healthcare Issues related to FDA's third party review program

Client expense: $300,000 · Firm income: Not reported

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

Reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, test coding and pricing, coverage, and payment, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); FDA and CMS policies related to diagnostics and laboratory regulation; price transparency for clinical laboratory services; H.R. 2377/S. 1000, Saving Access to Laboratory Services Act; H.R. 8818, Improving Seniors Timely Access to Care Act; H.R. 2369, the Verifying Accurate Leading-edge IVCT Development Act (VALID Act) of 2023; S. 3548.

Client expense: $510,000 · Firm income: Not reported

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

Reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, test coding and pricing, coverage, and payment, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); FDA and CMS policies related to diagnostics and laboratory regulation; public-private sector testing response in general and specific to Influenza A (H5) avian flu, monkeypox and oropouche; H.R. 2377/S. 1000, Saving Access to Laboratory Services Act; H.R. 8702/S. 4532, Improving Seniors Timely Access to Care Act; and H.R. 2369, the Verifying Accurate Leading-edge IVCT Development Act (VALID Act) of 2023.

Client expense: $510,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, White House Office

Matters pertaining to the VALID Act of 2023 (H.R.2369); Provisions that negatively impact Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory businesses; Docket No. FDA-2023-N-2177 (FDA's release of the Final Rule on LDTs

Client expense: Not reported · Firm income: Not reported

H.R.3046/S.1403 - Medical Student Education Authorization Act of 2023 Issue: Support grants for primary care training in medically under-resourced communities. Draft Social Determinants Accelerator Act Issue: Support grants to address social determinants of health. H.R.9161/S.4773 - Health Equity and Accountability Act of 2024 Issue: Support programs to improve health equity and address social determinants of health. S.2333 - Pandemic and All-Hazards Preparedness and Response Act H.R.4420 - Preparedness and Response Reauthorization Act H.R.4421 - Preparing for All Hazards and Pathogens Reauthorization Act H.R.4697 - Protecting PAHPA Act of 2023 Issues: Support the reauthorization of the Pandemic and All-Hazards Preparedness Act with increased funding authorization levels. Issue: Support authorities to strengthen CDCs and ASPRs ability to prevent and respond to existing and emerging threats. S.1995 - Public Health Infrastructure Saves Lives Act Issue: Support investments in core public health infrastructure. Issue: Educate Congress on how the 340B Drug Pricing Program helps safety-net providers to fulfill their missions and care for patients and communities. Support measures to preserve and strengthen the 340B Drug Pricing Program. Oppose efforts to reduce the scope of the program and transition 340B into a rebate model. H.R.2534 - Preserving Rules Ordered for the Entities Covered Through 340B Act of 2023 (PROTECT 340B Act) Issue: Support measures to prevent pharmacy benefit managers and commercial insurers from imposing discriminatory reimbursement policies on 340B covered entities. H.R.7635 - 340B Pharmaceutical Access to Invest in Essential, Needed Treatments and Support (340B PATIENTS) Act Issue: Support amending the 340B statute to codify covered entities ability to use contract pharmacies. H.R.3290 - To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program. Issue: Oppose efforts to impose additional reporting requirements on 340B hospitals. Draft Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B (SUSTAIN 340B) Act Issue: Support efforts to prohibit pharmaceutical and pharmacy benefit manager (PBM) discrimination against covered entities. Oppose efforts to define patient in the context of the program. Oppose efforts to impose additional administrative and reporting requirements on 340B hospitals. H.R.8574 - 340B ACCESS Act Issue: Oppose efforts to restrict hospital eligibility for the 340B program. Issue: Oppose insurance plans that do not meet Affordable Care Act requirements. Issue: Support policies to improve maternal health outcomes through expanded Medicaid coverage, enhanced data collection, and improved access to behavioral health care during the perinatal period. P.L. 118-159 - Servicemember Quality of Life Improvement and National Defense Authorization Act for Fiscal Year 2025 S.4638 National Defense Authorization Act for Fiscal Year 2025 Issue: Oppose prohibition on coverage for gender affirming care. H.R.2369 - Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2023 Issue: Educate Congress on development of laboratory developed tests (LDTs) at academic medical centers and oppose policies that would increase burdensome regulations and negatively impact patients access to care by allowing FDA regulation of the development of LDTs at academic medical centers. Issue: Educate Congress on the medical education and training continuum, the annual residency Match, and the role of the National Resident Matching Program (NRMP) in medical education and residency. Issue: Provide guidance on the implementation of the No Surprises Act (P.L.116-260). Issue: Educate Congress and the administration on the role of academic medicine in the provision of mental and behavioral health care, including initiatives to respond to the opioid epidemic. Support policies to strengthen the behavioral health workforce, promote the uptake of integrated behavioral health models, advance mental health research, and ensure access to coverage and care. Issue: Educate Congress about the financial challenges facing academic medical centers, including reimbursement challenges, workforce challenges, inflation, and others. Issue: Educate Congress and the administration about the impact of the unwinding of the COVID-19 public health emergency on the academic medicine community and the patients they serve. H.R.3887 - Childrens Hospital GME Support Reauthorization Act of 2023 H.R.3841 - To amend title III of the Public Health Service Act to reauthorize the program of payments to children's hospitals that operate graduate medical education programs. Issue: Support clean reauthorization of the Childrens Hospital GME program. Issue: Support reauthorization of the National Health Service Corps and Teaching Health Center Graduate Medical Education. Issue: Express concern regarding actions to inappropriately undermine FDA regulatory authority. Issue: Educate Congress and the administration about medical education on nutrition, hunger, and health; reproductive health; substance use disorders; medication assisted treatment for opioid use disorders; trans health; preventing fraud and abuse; diversity, equity, and inclusion; menopause management; health care for people with disabilities; and maternal health. Issue: Educate Congress and the administration about resident physician practice decision making post US SCOTUS decision in Dobbs. Issue: Educate Congress on resident expectations related to clinical practice and oppose so-called physician service mandates. H.R.7855 - Rural Residency Planning and Development Act of 2024 Issue: Support codification of HRSAs rural residency planning and development program. Issue: Support providing discretionary funds for rural teaching hospitals to expand their residency programs. Issue: Educate Congress on vaccine safety. Issue: Encourage changes to HRSA financial aid programs as a result of FAFSA updates. Issue: Educate Congress on the use of artificial intelligence (AI) in academic medicine. S.4031 - Providing Resources and Opportunities for Health Education and Learning (PRO-HEAL) Act Issue: Support HRSA grants to expand provider pipeline programs to create pathways to health care careers. H.R.7258/S.3968 - Community Training, Education, and Access for Medical Education, and Access for Medical Students (TEAMS) Act Issue: Support enhanced community-based training opportunities for medical students, particularly in rural and medically underserved areas, and fostering long-term sustainable physician practices in high-need communities. H.R.7153/S.3673 - Dr. Lorna Breen Health Care Provider Protection Reauthorization Act Issue: Support ability of HRSA to implement evidenced-based practices for preventing suicide and improving mental health and resiliency among health care professionals, and for training health care professionals in appropriate strategies to address substance use disorders. Issue: Provide input on Next Generation Cures initiative. Issue: Promote overdose prevention. H.R. 10047 The Closing the Substance Use Care Gap Act Issue: Support extension of SAMHSA harm reduction programs.

Client expense: $632,324 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Council on Disability, Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Science & Technology Policy (OSTP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Vice President of the U.S., White House Office

Regulation of Ethylene Oxide; H.R. 2369 VALID Act of 2023; H.R. 1691 the Ensuring Patient Access to Critical Breakthrough Products Act of 2023.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Generally promoting awareness of the biopharmaceutical and medical technology sectors. Generally opposing the imposition of price controls in the Medicare Part D program or elsewhere. Generally supporting intellectual property rights. Generally opposing various legislative and executive efforts to impose an international price index. Generally promoting awareness of increasing antimicrobial/antifungal resistance. Opposing CMS and CMMI Part D Payment Modernization Model amendments to Medicare's Six Protected Classes. Supporting the extension of the SBIR program. Generally supporting changes to the 340B program. Generally supporting efforts to require pharmacy benefit managers (PBMs) to pass on rebates to patients. Raising awareness within Congressional offices about Ethylene Oxide and EPA proposed regulations. Opposing proposed FTC changes to non-compete clauses. Generally promoting awareness of concerns regarding the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) and Coverage with Evidence Development (CED) policies that restrict patient access. Supporting the restoration of the orphan drug tax credit (Cameron's Law, H.R. 1350). Supporting the modernization of prescribing information to allow digital in lieu of printed information (H.R. 1503 and S. 2916). Supporting Ensuring Patient Access to Critical Breakthrough Products Act/MCET (H.R. 1691). Supporting the Verifying Accurate Leading-edge IVCT Development (VALID) Act (H.R. 2369). Supporting the Saving Access to Laboratory Services (SALSA) Act (H.R. 2377). Supporting the Protecting Patients Against PBM Abuses Act (H.R. 2880). Supporting the PASTEUR Act (H.R. 2940 and S. 1355). Supporting the Treat And Reduce Obesity Act (H.R. 4818, S. 2407). Supporting the Protecting Patient Access to Cancer and Complex Therapies Act (H.R. 5391 and S. 2764). Supporting the ORPHAN CURES Act (H.R. 5539). Supporting the Maintaining Investments in New Innovation (MINI) Act (H.R. 5547). Supporting the Delinking Revenue from Unfair Gouging (DRUG) Act (H.R. 6283). Supporting changes to the small molecule portions of the Inflation Reduction Act (H.R. 7174). Supporting "cap and smooth" efforts within the Inflation Reduction Act's cap on out-of-pocket expenses. Supporting CMS proposed rule, CMS-1809-P, to include separate payment for diagnostic radiopharmaceuticals in CY2025.

Client expense: $53,142 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to clinical diagnostic laboratory services; H.R. 2369 The Verifying Leading-edge IVCT Development Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2369: VALID Act of 2023; provisions related to the the Food and Drug Administration's Laboratory Developed Tests (LDT) Rule and regulation of diagnostics and lab developed tests H.R. 2407: Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; provisions related to coverage of Multi-Cancer Early Detection (MCED) tests General discussions related to the Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization

Client expense: $280,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, test coding and pricing, coverage, and payment, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); FDA and CMS policies related to diagnostics and laboratory regulation; FY 2024 budget and appropriations processes, extension of telehealth coverage policies, ordering of laboratory services pursuant to a telehealth visit, artificial intelligence in laboratory services; public-private sector testing response to Influenza A (H5) avian flu; H.R. 2377/S. 1000, Saving Access to Laboratory Services Act; H.R. 8818, American Privacy Rights Act of 2024; H.R. 8702/S. 4532, Improving Seniors Timely Access to Care Act; H.R. 7623, Telehealth Modernization Act of 2024; H.R. 8261, the Preserving Telehealth, Hospital, and Ambulance Access Act; H.R. 2369 the Verifying Accurate Leading-edge IVCT Development Act (VALID Act) of 2023.

Client expense: $575,000 · Firm income: Not reported

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

Reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, test coding and pricing, coverage, and payment, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); FDA and CMS policies related to diagnostics and laboratory regulation; price transparency for clinical laboratory services; H.R. 2377/S. 1000, Saving Access to Laboratory Services Act; H.R. 8818, American Privacy Rights Act of 2024; Improving Seniors Timely Access to Care Act; H.R. 7623, Telehealth Modernization Act of 2024; H.R. 8261, the Preserving Telehealth, Hospital, and Ambulance Access Act; H.R. 2369 the Verifying Accurate Leading-edge IVCT Development Act (VALID Act) of 2023.

Client expense: $575,000 · Firm income: Not reported

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

Reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, test coding and pricing, coverage, and payment, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); FDA and CMS policies related to diagnostics and laboratory regulation; FY 2024 budget and appropriations processes, artificial intelligence in laboratory services; public-private sector testing response in general and specific to Influenza A (H5) avian flu, monkeypox and oropouche; H.R. 2377/S. 1000, Saving Access to Laboratory Services Act; H.R. 8818, American Privacy Rights Act of 2024; H.R. 8702/S. 4532, Improving Seniors Timely Access to Care Act; and H.R. 2369, the Verifying Accurate Leading-edge IVCT Development Act (VALID Act) of 2023.

Client expense: $425,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, White House Office

Reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, test coding and pricing, coverage, and payment, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); FDA and CMS policies related to diagnostics and laboratory regulation; price transparency for clinical laboratory services; H.R. 2377/S. 1000, Saving Access to Laboratory Services Act; H.R. 8818, American Privacy Rights Act of 2024; Improving Seniors Timely Access to Care Act; H.R. 2369, the Verifying Accurate Leading-edge IVCT Development Act (VALID Act) of 2023; S. 3548, Health Care PRICE Transparency Act.

Client expense: $425,000 · Firm income: Not reported

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

S. 2477/H.R. 1770 Equitable Community Access to Pharmacist Services Act. H.R. 2369 Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2023. Proposals related to sterilization of medical devices. Proposals related to the President's Emergency Plan for AIDS Relief (PEPFAR). Proposals related to PT/INR (Prothrombin Time/International Normalized Ratio) testing. Proposals related to heart failure technology.

Client expense: $1,050,000 · Firm income: Not reported

Government targets: Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS)

H.R. 2369: VALID Act of 2023; provisions related to the the Food and Drug Administration's Laboratory Developed Tests (LDT) Rule and regulation of diagnostics and lab developed tests H.R. 2407: Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; provisions related to coverage of Multi-Cancer Early Detection (MCED) tests General discussions related to the Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization

Client expense: $260,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislative and regulatory proposals and policies regarding medical device innovation. H.R. 2369, Verifying Accurate, Leading-edge IVCT Development (VALID) Act of 2023. H.R. 1691, Ensuring Patient Access to Critical Breakthrough Products Act of 2023.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Privacy Legislation Issues related to the medical supply chain Issues related to the competitiveness of the medtech industry and the impact of Federal Policies Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to coverage and reimbursement of diagnostic tests VALID Act of 2023 - H.R. 2369. Issues related to Health Equity Issues related to Public Health Emergency Preparedness (including Pandemic All Hazards Preparedness Act reauthorization) Issues related to the use of Artificial Intelligence Issues related to MDUFA Reauthorization Issues related to PFAS Chemical regulation HR 3723 - the Medical Device Electronic Labeling Act HR 5662/S 2907 - the Medical Device Recall Improvement Act S 2672 - Improving Development and Distribution of Diagnostic Tests Act HR 3795 - Diagnostic Testing Preparedness Plan Reimbursement and coverage of focused ultrasound technology HR 1328, the Medical Device Nonvisual Accessibility Act of 2023 Issues related to FDAs third party review program

Client expense: $960,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

Federal policy and programs regarding oncology research and development related to cancer screening, diagnosis, and survivorship Federal policy related to strengthening the clinical laboratory workforce H.R. 3248 - Diagnostic Lab Testing Transparency Act H.R. 5378 - Lower Costs, More Transparency Act H.R. 2369 - the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2023 Food and Drug Administration (FDA) policies related to diagnostics and laboratory regulation

Client expense: $430,000 · Firm income: Not reported

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

Federal policy and programs regarding oncology research and development related to cancer screening, diagnosis, and survivorship H.R. 9849 - Medical Laboratory Personnel Shortage Relief Act of 2024 H.R. 3248 - Diagnostic Lab Testing Transparency Act H.R. 5378 - Lower Costs, More Transparency Act H.R. 2369 - the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2023 H.R. 88188 - American Privacy Rights Act of 2024 Food and Drug Administration (FDA) policies related to diagnostics and laboratory regulation CMS policies related to Medicare Advantage Engagement with executive branch departments/agencies regarding influenza A (H5) "Avian Flu"

Client expense: $410,000 · Firm income: Not reported

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

Healthcare issues related to clinical laboratories; H.R. 2377/S. 1000, the Saving Access to Laboratory Services Act (SALSA), Section 301 of H.R. 8261, the Preserving Telehealth, Hospital and Ambulance Access Act, Section 401 of H.R. 7623, the Telehealth Modernization Act, Section 221 of Division B, Title II, Subtitle C of Pub. L. 118-83, 138 Stat. 1524, H.R. 9747, the Continuing Appropriations and Extension Act, 2025, 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; H.R. 8818, the American Privacy Rights Act, provisions relating to privacy and security of data; H.R. 8702/S. 4518, the Improving Seniors Timely Access to Care Act, provisions relating to prior authorization of services to Medicare Advantage beneficiaries; Section 106(b) of H.R. 8261, the Preserving Telehealth, Hospital and Ambulance Access Act, and Section 103(b) of H.R. 7623, the Telehealth Modernization Act, provisions relating to Medicare program integrity for clinical diagnostic laboratory test claims; S. 2140, the Patent Eligibility Restoration Act, provisions relating to patent subject matter eligibility; 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 supply chain issues affecting pre-clinical biomedical research for drug development;

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.3046/S.1403 - Medical Student Education Authorization Act of 2023 Issue: Support grants for primary care training in medically under-resourced communities. Draft Social Determinants Accelerator Act Issue: Support grants to address social determinants of health. H.R.9161/S.4773 - Health Equity and Accountability Act of 2024 Issue: Support programs to improve health equity and address social determinants of health. S.2333 - Pandemic and All-Hazards Preparedness and Response Act H.R.4420 - Preparedness and Response Reauthorization Act H.R.4421 - Preparing for All Hazards and Pathogens Reauthorization Act H.R.4697 - Protecting PAHPA Act of 2023 Issues: Support the reauthorization of the Pandemic and All-Hazards Preparedness Act with increased funding authorization levels. Issue: Support authorities to strengthen CDCs and ASPRs ability to prevent and respond to existing and emerging threats. S.1995 - Public Health Infrastructure Saves Lives Act Issue: Support investments in core public health infrastructure. Issue: Educate Congress on how the 340B Drug Pricing Program helps safety-net providers to fulfill their missions and care for patients and communities. Support measures to preserve and strengthen the 340B Drug Pricing Program. Oppose efforts to reduce the scope of the program, restrict the use of contract pharmacies, define patient in the context of the program, and impose additional reporting requirements on 340B hospitals. Oppose pharmaceutical industry efforts to transition 340B into a rebate model. H.R.2534 - Preserving Rules Ordered for the Entities Covered Through 340B Act of 2023 (PROTECT 340B Act) Issue: Support measures to prevent pharmacy benefit managers and commercial insurers from imposing discriminatory reimbursement policies on 340B covered entities. H.R.7635 - 340B Pharmaceutical Access to Invest in Essential, Needed Treatments and Support (340B PATIENTS) Act Issue: Support amending the 340B statute to codify covered entities ability to use contract pharmacies. H.R.3290 - To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program. Issue: Oppose efforts to impose additional reporting requirements on 340B hospitals. Draft Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B (SUSTAIN 340B) Act Issue: Support efforts to prohibit pharmaceutical and pharmacy benefit manager (PBM) discrimination against covered entities. Oppose efforts to define patient in the context of the program. Oppose efforts to impose additional administrative and reporting requirements on 340B hospitals. H.R.8574 - 340B ACCESS Act Issue: Oppose efforts to restrict hospital eligibility for the 340B program. Issue: Oppose insurance plans that do not meet Affordable Care Act requirements. Issue: Support policies to improve maternal health outcomes through expanded Medicaid coverage, enhanced data collection, and improved access to behavioral health care during the perinatal period. H.R.2369 - Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2023 Issue: Educate Congress on development of laboratory developed tests (LDTs) at academic medical centers and oppose policies that would increase burdensome regulations and negatively impact patients access to care by allowing FDA regulation of the development of LDTs at academic medical centers. Issue: Educate Congress on the medical education and training continuum, the annual residency Match, and the role of the National Resident Matching Program (NRMP) in medical education and residency. Issue: Provide guidance on the implementation of the No Surprises Act (P.L.116-260). Issue: Educate Congress and the administration on the role of academic medicine in the provision of mental and behavioral health care, including initiatives to respond to the opioid epidemic. Support policies to strengthen the behavioral health workforce, promote the uptake of integrated behavioral health models, advance mental health research, and ensure access to coverage and care. Issue: Educate Congress about the financial challenges facing academic medical centers, including reimbursement challenges, workforce challenges, inflation, and others. Issue: Educate Congress and the administration about the impact of the unwinding of the COVID-19 public health emergency on the academic medicine community and the patients they serve. H.R.3887 - Childrens Hospital GME Support Reauthorization Act of 2023 H.R.3841 - To amend title III of the Public Health Service Act to reauthorize the program of payments to children's hospitals that operate graduate medical education programs Issue: Support clean reauthorization of the Childrens Hospital GME program. Issue: Express concern regarding actions to inappropriately undermine FDA regulatory authority. Issue: Educate Congress and the administration about medical education on nutrition, hunger, and health; reproductive health; substance use disorders; medication assisted treatment for opioid use disorders; trans health; preventing fraud and abuse; diversity, equity, and inclusion; menopause management; health care for people with disabilities; and maternal health. Issue: Educate Congress and the administration about resident physician practice decision making post Dobbs. Issue: Educate Congress on resident expectations related to clinical practice and oppose so-called physician service mandates. H.R.7855 - Rural Residency Planning and Development Act of 2024 Issue: Support codification of HRSAs rural residency planning and development program. Issue: Educate Congress on vaccine safety. Issue: Encourage changes to HRSA financial aid programs as a result of FAFSA updates. Issue: Educate Congress on the use of artificial intelligence (AI) in academic medicine. S.4031 - Providing Resources and Opportunities for Health Education and Learning (PRO-HEAL) Act Issue: Support HRSA grants to expand provider pipeline programs to create pathways to health care careers. H.R.7258/S.3968 - Community Training, Education, and Access for Medical Education, and Access for Medical Students (TEAMS) Act Issue: Support enhanced community-based training opportunities for medical students, particularly in rural and medically underserved areas, and fostering long-term sustainable physician practices in high-need communities. H.R.7153/S.3673 - Dr. Lorna Breen Health Care Provider Protection Reauthorization Act Issue: Support ability of HRSA to implement evidenced-based practices for preventing suicide and improving mental health and resiliency among health care professionals, and for training health care professionals in appropriate strategies to address substance use disorders. Issue: Provide input on Next Generation Cures initiative. Issue: Promote overdose prevention.

Client expense: $617,103 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Council on Disability, Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Science & Technology Policy (OSTP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Vice President of the U.S., White House Office