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Legislative Progress
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vs 5,357 other S bills in the 117th — cohort avg 38d
Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act or the DIVERSE Trials Act This bill requires activities to increase diversity in clinical trials. It also expands reporting by laboratories that test for and diagnose COVID-19 and requires a study on data collection and data sharing during public health emergencies. Specifically, the Food and Drug Administration (FDA) must issue guidance on decentralized clinical trials to promote meaningful demographic and geographic diversity in patient engagement, enrollment, and participation. Decentralized clinical trials include those executed through telemedicine or other digital technologies to allow for the remote collection and assessment of clinical trial data. The FDA may also work with foreign regulators to harmonize international regulations governing decentralized clinical trials and the use of digital health technology. In addition, the Department of Health and Human Services (HHS) may support community education, outreach, and recruitment activities for clinical trials of treatments for conditions that disproportionately impact populations underrepresented in clinical trials. The bill also specifies that drug or device manufacturers may provide, subject to some limits, free digital health technologies and other remuneration to patients in approved clinical trials without violating laws that address fraud and abuse in federal programs. Furthermore, laboratories that test for and diagnose COVID-19 must report additional demographic data, including information about social determinants of health. HHS must also contract with the National Academy of Medicine to study and propose a design for an interoperable platform to facilitate data sharing during public health emergencies.
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Filing registrants (35)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2023 · second_quarter · Health Issues
Patient Access Issues Healthcare Appropriations The Pharmacy Benefit Manager (PBM) Transparency Act of 2022 CDC Appropriation NIH Report Language S.464 Safe Step Act S. 2706 DIVERSE Trials Act H.R. 5801 HELP Copays Act H.R. 6584 DEPICT Act
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Pharmacist equitable access, health equity. H.R. 7213 Clinical trial diversity, health equity. H.R. 5030/S. 2706 Emergency preparedness and response. S. 3799 Healthcare innovation, ARPA-H, oncology research. H.R. 6000 Laboratory diagnostic services, schedule reimbursement S. 4449 Omnibus federal appropriations Pandemic Response Biden Cancer Moonshot Initiative H.R.3258 Timely Access to Cancer Treatment Act. H.R.2163, S.464 The Safe Step Act. H.R. 8800 Supporting Medicare Providers Act of 2022
Client expense: $810,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
Advocated in favor of robust appropriations funding for the National Institutes of Health, the Food and Drug Administration, the Health Resources and Services Administration, and the Centers for Disease Control and Prevention. Advocated for greater appropriations for the National Center for Advancing Translational Sciences (NCATS) Advocated for greater appropriations for the National Institutes of Health. Advocated for appropriations for HHS, NIH, and FDA to implement the ACT for ALS. Advocated for the passage of the Newborn Screening Saves Lives Reauthorization Act, H.R. 482 / S. 350, to encourage investment in the national newborn screening program in order to detect more neuromuscular conditions early to speed appropriate interventions for patients. Supported the passage of the e Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (H.R. 5030/S. 2706) Advocated for reforms to the FDA Accelerated Approval program as part of the end-of-year omnibus legislation. Advocated for the creation of an FDA regulatory pathway for diagnostics, including lab-developed tests and invitro diagnostics. Advocated for the passage of the RARE Act (S. 4185) as part of the Senate FDA User Fee process. Advocated for certain provisions within the Cures 2.0 Legislation (H.R.6000) Advocated for passage of FDA and clinical trial reforms within an end-of-year bill, including accelerated approval reforms, clinical trial diversity advancements, the RARE Act, reauthorization of the Orphan Product Grants Program, and more.
Client expense: $220,000 · Firm income: Not reported
2022 · fourth_quarter · Health Issues
Health care issues affecting individuals with neuromuscular disease including therapy development, newborn screening, screening and diagnosis, adequate insurance coverage, and access to care. Advocated for the passage of the Newborn Screening Saves Lives Reauthorization Act, H.R. 482 / S. 350, to encourage investment in the national newborn screening program in order to detect more neuromuscular conditions early to speed appropriate interventions for patients. Advocated for robust funding of the national newborn screening program. Advocated for increased funding for National Institutes of Health, Food and Drug Administration, Health Resources and Services Administration, Centers for Disease Control and Prevention, and other health agencies that conduct research on neuromuscular disease and provide services to those with these conditions. Advocated for adequate, affordable, accessible health coverage for individuals with neuromuscular conditions. Advocated for the swift funding and implementation of the ACT for ALS Act (S.1813 and H.R.3537). Advocated for access to healthcare via telemedicine/telehealth throughout and after the COVID-19 public health emergency. Advocated for increased funding of home and community-based services (HCBS). Supported the passage of the e Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (H.R. 5030/S. 2706) Advocated for reforms to the FDA Accelerated Approval program as part of the end-of-year omnibus package. Advocated for the creation of an FDA regulatory pathway for diagnostics, including lab-developed tests and invitro diagnostics. Supported greater appropriations for Consumer Assistance Programs Advocated for the passage of the RARE Act (S. 4185) as part of the end-of-year omnibus package. Supported passage of the Ending the Diagnostic Odyssey Act Advocated for the passage of the Accelerating Kids Access to Care Act Advocated for certain provisions within the Cures 2.0 Legislation (H.R.6000) Support the passage of the Precision Medicine for Children Act Advocated for the passage of the HCBS Access Act Supported the passage of the Stop the Wait Act (S. 3575 / H.R. 6583) Advocated for the Access to Genetic Counselors Act Provided recommendations to the Department of Health and Human Services on the implementation of section 1557 of the Affordable Care Act. Applauded the Department of Health and Human Services in their closing of the family glitch within the Affordable Care Act. Advocated to the Centers for Medicare and Medicaid Services on Medicaid access and the COVID-19 public health emergency Called for passage of the Preserving Patient Access to Home Infusion Act (S. 2652/H.R. 5067) Provided comments to CMS on ensuring equity in accessing health care. Provided comments to the Department of Health and Human Services on how best to streamline eligibility and enrollment within the Medicaid and CHIP programs. Called for recipients of the Deferred Action for Childhood Arrivals program to access Federal health programs and offerings. Provided comments to the CMS on the implementation of the No Surprises Act. Called for greater funding of the National Center for Advancing Translational Sciences (NCATS) Called for the passage of the Medicare Orthotic & Prosthetic Patient-Centered Care Act Provided comments to CMS on National Directory of Healthcare Providers and Services
2022 · fourth_quarter · Pharmacy
Advocated for funding and implementation of the ACT for ALS, a law that should accelerate development of treatments for individuals with ALS and other neuromuscular diseases. Advocated for the passage of the Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (H.R. 5030/S. 2706) Supported passage of the Ending the Diagnostic Odyssey Act Advocated for the passage of the Accelerating Kids Access to Care Act Advocated for certain provisions within the Cures 2.0 Legislation (H.R.6000) Support the passage of the Precision Medicine for Children Act Advocated for reforms to the FDA Accelerated Approval program as part of the end-of-year omnibus package Advocated for the creation of an FDA regulatory pathway for diagnostics, including lab-developed tests and invitro diagnostics. Advocated for passage of FDA and clinical trial reforms within an end-of-year bill, including accelerated approval reforms, clinical trial diversity advancements, the RARE Act, reauthorization of the Orphan Product Grants Program, and more.
Client expense: $220,000 · Firm income: Not reported
| Democratic |
| MD |
| Catherine Cortez Masto | Democratic | NV |
| Chris Van Hollen | Democratic | MD |
| Cory A. Booker | Democratic | NJ |
| Debbie Stabenow | Democratic | MI |
| Edward J. Markey | Democratic | MA |
| Jack Reed | Democratic | RI |
| Jerry Moran | Republican | KS |
| Jon Tester | Democratic | MT |
| Kyrsten Sinema | Independent | AZ |
| Lisa Murkowski | Republican | AK |
| Marsha Blackburn | Republican | TN |
| Mike Braun | Republican | IN |
| Patrick J. Leahy | Democratic | VT |
| Richard Blumenthal | Democratic | CT |
| Robert P. Casey, Jr. | Democratic | PA |
| Sherrod Brown | Democratic | OH |
| Susan M. Collins | Republican | ME |
| Tammy Duckworth | Democratic | IL |
| Thomas R. Carper | Democratic | DE |
| Tim Scott | Republican | SC |
| Tina Smith | Democratic | MN |
| Todd Young | Republican | IN |
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
Client expense: $220,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Natl Council on Disability, Natl Institutes of Health (NIH), SENATE, Treasury, Dept of
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
The Pharmacy Benefit Manager (PBM) Transparency Act of 2022 CDC Appropriation NIH Report Language S.464 Safe Step Act S. 2706 DIVERSE Trials Act H.R. 5801 HELP Copays Act H.R. 6584 DEPICT Act
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R. 379/S. 104 - Improving Social Determinants of Health Act; bill to require the Centers for Disease Control and Prevention (CDC) to establish a program to improve health outcomes and reduce health inequities by, for example, coordinating activities across the CDC. As part of the program, the CDC must award grants to eligible organizations to build capacity to address social determinants of health. H.R. 469 - Comprehensive Breast Reconstruction Act of 2021; bill provides for Medicare, Medicaid, and private health insurance coverage of certain tattooing services in connection with post-mastectomy breast reconstruction, and aligns the scope of Medicare and Medicaid coverage of such breast reconstruction with that of private health insurance. H.R. 5030/S.2706 - DIVERSE Trials Act; A bill to require FDA to issue guidance on decentralized clinical trials to promote meaningful demographic/geographic diversity in patient engagement, expand reporting by laboratories that test for and diagnose COVID-19, and require a study on data collection and data sharing during public health emergencies H.R. 6000 - Cures 2.0 Act; a comprehensive healthcare and biomedical research bill H.R. 4794/S. 2533 - Making Advances in Mammography and Medical Options for Veterans Act; a bill to improve mammography services furnished by the Department of Veterans Affairs H.R. 4571/S. 2102 - Supporting Expanded Review for Veterans in Combat Environments (SERVICE) Act of 2021; a bill to expand eligibility for Veterans Health Administration mammography screenings to veterans who served in certain locations during specified periods, including those who were exposed to toxic substances at such locations H.R. 6584 - Diverse and Equitable Participation in Clinical Trials (DEPICT) Act; a bill to direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes. S. 3799 - Prepare for and Respond to Existing Viruses, Emerging New Threats, (PREVENT) and Pandemics Act; a bill to prepare for, and respond to, existing viruses, emerging new threats, and pandemics. H.R. 7845 NIH Clinical Trial Diversity Act; a bill to direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes. H.R. 8185/S. 4440 - Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act; a bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2023 through 2027 S. 4260 - Palliative Care and Hospice Education and Training Act; a bill to increase the number of permanent faculty in palliative care at accredited allopathic and osteopathic medical schools, nursing schools, social work schools, and other programs, including physician assistant education programs, to promote education and research in palliative care and hospice, and to support the development of faculty careers in academic palliative medicine. H.R. 7667/S. 4348 - Food and Drug Amendments of 2022; a bill to reauthorize Food and Drug Administration (FDA) user fee programs for certain drugs and devices, establishes requirements to increase diversity in clinical trials, and modifies requirements relating to the overall supply chain for drugs and devices. H.R. 9565/S. 5295- Comprehensive Cancer Survivorship Act; a bill to address the health of cancer survivors and unmet needs that survivors face through the entire continuum of care from diagnosis through active treatment and posttreatment, in order to improve survivorship, treatment, transition to recovery and beyond, quality of life and palliative care, and long-term health outcomes, including by developing a minimum standard of care for cancer survivorship, irrespective of the type of cancer, a survivors background, or forthcoming survivorship needs, and for other purposes. Policies related to telehealth Policies to increase clinical trial diversity and access for underrepresented populations Policies related to genetic counseling and testing Policies related to cancer survivorship Policies related to PBM and drug cost transparency Policies related to the reauthorization of FDA User Fee Agreements Policies related to the implementation of the Breast Density and Mammography Reporting Act of 2017 Policies related to the implementation of the Mammography Quality Standards Act Policies related to administration actions necessary in breast imaging and breast cancer diagnosis Comments regarding a request for information on establishing a National Directory of Healthcare Providers and Services
Client expense: $50,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE
2022 · fourth_quarter · Health Issues
H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act; all provisions of the bill H.R. 4390: Preserving Rules Ordered for The Entities Covered Through (PROTECT) 340B Act of 2021; all provisions of the bill H.R. 5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act; all provisions of the bill H.R. 6000: Cures 2.0 Act; all healthcare provisions of the bill H.R. 6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act; all provisions of the bill H.R. 6833: Affordable Insulin Now Act; provisions related to the Prescription Drug User Fee Act Reauthorization H.R. 6963: Accelerated Approval Integrity Act of 2022; all provisions of the bill H.R. 6996: Accelerating Access for Patients Act of 2022; all provisions of the bill H.R. 7667: Food and Drug Amendments of 2022; provisions related to drug development user fees S. 2706: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act; all provisions of the bill S. 4348: Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022; provisions related to drug development user fees S. 4535: Food and Drug Administration Simple Reauthorization (FDASRA) Act of 2022; provisions related to drug development user fees 2021 Notice of Benefit and Payment Parameters Proposed Rule - 340B Drug Pricing Program policy issues P.L. 117-169 (H.R. 5376): Inflation Reduction Act of 2022; all provisions of the bill General healthcare issues surrounding the COVID-19 pandemic General issues surrounding healthcare supply chain General discussions regarding drug cost and pricing policy issues General discussions related to the Cancer Moonshot Initiative and the Advanced Research Projects Agency for Health (ARPA-H) General discussion related to the Prescription Drug User Fee Act Reauthorization
Client expense: $550,000 · 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
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
H.R. 482: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS H.R. 869: RESEARCH INVESTMENT TO SPARK THE ECONOMY (RISE) ACT OF 2021; ALL PROVISIONS H.R. 3932: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2021; ALL PROVISIONS H.R. 5030: DIVERSIFYING INVESTIGATIONS VIA EQUITABLE RESEARCH STUDIES FOR EVERYONE (DIVERSE) TRIALS ACT; ALL PROVISIONS H.R. 5566: FINDING ORPHAN-DISEASE REMEDIES WITH ANTIFUNGAL RESEARCH AND DEVELOPMENT (FORWARD) ACT OF 2021; ALL PROVISIONS H.R. 6000: CURES 2.0 ACT; ALL PROVISIONS S. 289: RESEARCH INVESTMENT TO SPARK THE ECONOMY (RISE) ACT OF 2021; ALL PROVISIONS S. 350: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS S. 2076: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2021; ALL PROVISIONS S. 2706: DIVERSIFYING INVESTIGATIONS VIA EQUITABLE RESEARCH STUDIES FOR EVERYONE (DIVERSE) TRIALS ACT; ALL PROVISIONS S. 3799: PREPARE FOR AND RESPOND TO EXISTING VIRUSES, EMERGING NEW THREATS, AND (PREVENT) PANDEMICS ACT; PROVISIONS REGARDING MEDICAL SUPPLY CHAIN, HEALTH DISPARITIES, PUBLIC HEALTH PREPAREDNESS AND RESPONSE CAPABILITIES GENERAL DISCUSSIONS REGARDING THE 2023 FISCAL YEAR APPROPRIATIONS; PROVISIONS RELATING TO FUNDING FOR HHS AND RELATED AGENCIES, FDA AND RELATED AGENCIES, CDC AND RELATED AGENCIES, FUNDING FOR NUTRITION ASSISTANCE PROGRAMS, AND MEDICAL EXPENSE DEDUCTION
Client expense: $110,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R. 482: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS H.R. 708: TEMPORARY RECIPROCITY TO ENSURE ACCESS TO TREATMENT (TREAT) ACT; ALL PROVISIONS H.R. 3932: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2021; ALL PROVISIONS H.R. 4040: ADVANCING TELEHEALTH BEYOND COVID-19 ACT OF 2022; ALL PROVISIONS H.R. 5030: DIVERSIFYING INVESTIGATIONS VIA EQUITABLE RESEARCH STUDIES FOR EVERYONE (DIVERSE) TRIALS ACT; ALL PROVISIONS H.R. 5566: FINDING ORPHAN-DISEASE REMEDIES WITH ANTIFUNGAL RESEARCH AND DEVELOPMENT (FORWARD) ACT OF 2021; ALL PROVISIONS H.R. 5801: HELP ENSURE LOWER PATIENT (HELP) COPAYS ACT; ALL PROVISIONS H.R. 6000: CURES 2.0 ACT; ALL PROVISIONS H.R. 9303: SAVING US FROM PANDEMIC ERA RESISTANCE BY BUILDING A UNIFIED GLOBAL STRATEGY (SUPER BUGS) ACT OF 2022; ALL PROVISIONS S. 168: TEMPORARY RECIPROCITY TO ENSURE ACCESS TO TREATMENT (TREAT) ACT; ALL PROVISIONS S. 350: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS S. 368: TELEHEALTH MODERNIZATION ACT; ALL PROVISIONS S. 942: NO JUNK PLANS ACT; ALL PROVISIONS S. 2076: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2021; ALL PROVISIONS S. 2706: DIVERSIFYING INVESTIGATIONS VIA EQUITABLE RESEARCH STUDIES FOR EVERYONE (DIVERSE) TRIALS ACT; ALL PROVISIONS S. 3799: PREPARE FOR AND RESPOND TO EXISTING VIRUSES, EMERGING NEW THREATS, AND (PREVENT) PANDEMICS ACT; PROVISIONS REGARDING MEDICAL SUPPLY CHAIN, HEALTH DISPARITIES, PUBLIC HEALTH PREPAREDNESS AND RESPONSE CAPABILITIES GENERAL DISCUSSIONS REGARDING ACE KIDS 2.0; ALL PROVISIONS
Client expense: $110,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Pharmacist equitable access, health equity. H.R. 7213 Clinical trial diversity, health equity. H.R. 5030/S. 2706 Emergency preparedness and response. S. 3799 Healthcare innovation, ARPA-H, oncology research. H.R. 6000 Laboratory diagnostic services, schedule reimbursement S. 4449 Omnibus federal appropriations Pandemic Response Biden Cancer Moonshot Initiative H.R.3258 Timely Access to Cancer Treatment Act. H.R.2163, S.464 The Safe Step Act. H.R. 8800 Supporting Medicare Providers Act of 2022
Client expense: $440,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2022 · fourth_quarter · Health Issues
Issues relating to access to care, health disparities, childhood cancer, quality of life and palliative care, cancer survivorship, federal health care programs, genetic information, cancer, nutrition, tanning beds, clinical trials, skin cancer, cannabis research, and wellness, including: The Inflation Reduction Act, HR 5376 - extension of expanded tax credits for ACA marketplaces; HR 1550, The Prevent HPV Cancers Act S. 699, Women and Lung Cancer Research and Preventive Services Act of 2021 HR 623, Gabriella Miller Kids First Research Act 2.0 S. 4260, The Palliative Care and Hospice Education and Training Act Provider Training in Palliative Care Act, S 2890 Issues related to the possible introduction of the 21st Century Cures Act version 2.0 Regulations implementing the No Suprises Act Proposed Rule on Affordability of Employer Coverage for Family Members of Employees, REG-114339-21 Regulations related to short term limited duration health insurance plans (upcoming) OMB RFI on health equity - comments DICT RFI - Eshoo DICT Ancillary Costs legislation/Menendez, Scott, Smith, Young, Ruiz House/Senate Appropriations Committee FDA DICT report language Reducing Hereditary Cancer Act of 2021 - DWS, Slotkin, Miller-Meeks, and Davis Personal Care Products Safety Act - Feinstein, Collins H.R. 6638 - Reducing COVID-19 Disparities by Investing in Public Health Act of 2021 The VALID Act - DeGette, Bennet, Burr, Buschon DIVERSE Trials Act - H.R.5030/ S.2706 DEPICT Act, HR 6584 Give Kids a Chance Act, H.R. 6972 NIH Clinical Trials Diversity Act, HR 7845 HR 7667, Food and Drug Amendments Act Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, S 4348 S. 4185, the Retaining Access and Restoring Exclusivity (RARE) Act Potential legislation on cancer survivorship being developed by Rep. Wasserman Schultz Health Equity and Accountability Act, HR 7585 Notice of Benefit and Payment Parameters, regulatory comments Regulatory issues related to healthy food and dietary guidelines
Client expense: $1,990,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, White House Office
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
DIVERSE Trials Act, HR 5030/S 2706 HR 623, Gabriella Miller Kids First Research Act 2.0 Issues related to the possible introduction of the 21st Century Cures Act version 2.0 DICT RFI - Eshoo DICT Ancillary Costs legislation/Menendez, Scott, Smith, Young, Ruiz House/Senate Appropriations Committee FDA DICT report language DEPICT Act, HR 6584 NIH Clinical Trials Diversity Act, HR 7845 HR 7667, Food and Drug Amendments Act Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, S 4348
Client expense: $1,990,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, White House Office
2022 · fourth_quarter · Health Issues
HR 2617, the Consolidated Appropriations Act 2023; , 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; 2024 Notice of Benefit and Payment Parameters regulation
Client expense: $140,000 · 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
2022 · fourth_quarter · Health Issues
- HR 1978/S 912, "Protecting Seniors Through Immunization Act", regarding all provisions - HR 6007, "To amend title XVIII of the Social Security Act to provide for the expansion of coverage of vaccines under part B of the Medicare program, and for other purposes", regarding all provisions - H.Res. 446, Expressing support for the goals and ideals of National Stroke Awareness Month, regarding all provisions - S 610/HR 1667, "The Dr. Lorna Breen Health Care Provider Protection Act", regarding all provisions - HR 3, "Elijah E. Cummings Lower Drug Costs Now Act", regarding all provisions - S 1784/HR 3353, Contact Lens Prescription Verification Modernization Act, regarding all provisions - HR 5030/S 2706, "The Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act, regarding all provisions - S 3394, "Emergency Use Transparency Act", regarding all provisions - HR 3990/S 2047, "No PFAS in Cosmetics Act", regarding all provisions - HR 8299/S 4386, "To allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan.", regarding all provisions - HR 7667/S 4348, "Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act", regarding provisions on accelerated approval and diversity in clinical studies - HR 5801, "HELP Copays Act", regarding all provisions - HR 3173/S 3018 - "Improving Seniors Timely Access to Care Act of 2021", regarding all provisions - S 3799 - "PREVENT Pandemics Act", regarding all provisions - HR 3932/S 2076 - "PASTEUR Act of 2021", regarding all provisions - HR 5376 - "Inflation Reduction Act", regarding provisions on drug pricing and provisions related to revenue - HR 7559 - Prescription Information Modernization Act of 2022, regarding all provisions - HR 2617 - "Consolidated Appropriations Act, 2023", regarding provisions related to pharmaceuticals, medical devices, mental health, and tax - Issues related to Dengue - Issues related to prescription drug pricing - Issues related to health care pricing transparency - Issues related to maternal health - Issues related to frontline health workers - Issues related to over the counter products - Issues related to the regulation of cosmetic products - Issues related to the regulation of dietary supplements - Issues related to stroke care - Issues related to counterfeit health care goods - Issues related to 340B drug pricing program - Issues related to antimicrobial resistance - Issues related to the COVID-19 vaccine development, including diversity in clinical trials - Issues related to Medicare Part D's 6 protected classes - Issues related to global public health and ending tuberculosis - Issues pertaining to health equity and social determinants of health - Issues related to FDA medical device shortage reporting requirements, including implementation of CARES Act requirements - Issues related to lung cancer screening - Issues related to clinical research diversity - Issues related to international harmonization of medical device regulation
Client expense: $2,270,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
Sickle cell disease/trait issues Hematology/oncology treatment issues Hematology/oncology drug research and approval issues General hematology public health and research issues Emergency funding for COVID therapeutics Research Investment to Spark the Economy (RISE) Act (H.R. 869/S. 289) Open access policy for peer reviewed research journals Issues impacting blood supply shortages/safety Issues related to convalescent plasma Issues impacting delivery of bone marrow, peripheral blood, and cord blood Issues related to implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136) Issues related to health equity/disproportionate impact of COVID-19 on minority populations COVID-19 vaccination policies/prioritization Clinical trials regulations and coverage Issues related to diversity, equity, and inclusion (DEI) in hematology research, practice, and training Cures 2.0 Act (H.R. 6000) Advanced Research Projects Agency for Health (ARPA-H) Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (S. 2706 / H.R. 5030) Meaningful Access to Federal Health Plan Claims Data Act (H.R. 5394) Health Equity and Accountability Act (H.R. 7585) Verifying Accurate Leading-edge IVCT Development (VALID) Act (H.R. 4128/S. 2209) Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act (S. 4348)
Client expense: $30,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), President of the U.S., SENATE
2022 · fourth_quarter · Health Issues
H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 1730/S. 670- Speeding Therapy Access Today Act H.R. 1946, S. 1873. Cancer Moonshot Items related to the Administrations Cancer Moonshot initiative; H.R. 5030/ S. 2706 DIVERSE Trials Act HR 5376, Inflation Reduction Act reconciliation bill; Medicare price negotiation provision and Part D redesign; Preventative healthcare services and screenings; Issues related to preventative services and screenings for underrepresented communities H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 Accelerating Access for Patients Act; H.R.7667 - Food and Drug Amendments of 2022; S. 1548, H.R. 3085/H.R. 7845. ENACT Act of 2021 S.4348 - FDASLA Act of 2022; General issues related to rare disease and orphan drugs; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; general issues related to health equity in rare disease and clinical trials; general issues related to diagnostics for patients with rare diseases; general issues related to pharmacy benefit managers (PBMs); general issues related to insurance coverage of specialty treatments Issues related to clinical trial diversity COVID-19; COVID-19 vaccine and therapy development Climate, sustainability, and environment; Sustainability & Zero Carbon; Items related to environmental sustainability (including eliminating GHG emissions from pMDIs) and our Ambition Zero Carbon efforts. E-Labeling EVUSHELD Issues related to repeal of the Medicaid AMP Cap. Issues related to drug pricing, IRA Drug Regulation, Approval, Clinical Trial Diversity and FDA User Fees;
Client expense: $1,170,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
Drug Regulation, Approval, Clinical Trial Diversity and FDA User Fees; Cancer Moonshot Items related to the Administrations Cancer Moonshot initiative; H.R. 6000-CURES Act 2.0 H.R. 5030/ S. 2706- DIVERSE Trials Act H.R. 6584- DEPICT Act H.R. 3085/S. 1548- ENACT Act of 2021 H.R. 7845- NIH Clinical Trial Diversity Act of 2022 H.R. 1946/, S. 1873- Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021
Client expense: $1,170,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Issues related to lung disease treatment, prevention and research; Issues related to public health; Issues related asthma, COPD, influenza, lung cancer, pneumonia, pulmonary fibrosis, tuberculosis and other lung diseases; Issues related to tobacco cessation; Issues related to the Affordable Care Act; Issues related to the Childrens Health Insurance Program; Issues related to COVID-19 Response; Issues related to vaccines; Issues related to the SUNSET Rule; Issues related to infrastructure; Issues related to supplemental oxygen; Issues relating to the Presidents FY24 budget; Issues related to the implementation of the No Surprises Act; Issues related to Medicare sequestration; Issues related to FY23 appropriations bills; Issues related to Cancer Moonshot; Issues related to Implementation of ACA; Issues related to Short-Term Limited Duration Plans; Issues related to Healthy Future Taskforce, H.R. 8295 Labor HHS Appropriations bill; S. 4659 Labor HHS Appropriations bill; H.R.3173 Improving Seniors Timely Access to Care Act; H.R.107 Lung Cancer Screening Registry and Quality Improvement Act of 2021; H.R.1946 To amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests; H.R.2140 To prioritize funding for an expanded and sustained national investment in basic science research; S.571 Public Health Funding Prevents Pandemics Act; S.961 A bill to prioritize funding for an expanded and sustained national investment in basic science research; S.962 A bill to prioritize funding for an expanded and sustained national investment in biomedical research; H.R.66 CARING for Kids Act; H.R.1390 CHIPPER Act; H.R.1583 To fully fund the Prevention and Public Health Fund and reaffirm the importance of prevention in the United States health care system; H.R.1738 To amend titles XIX and XXI of the Social Security Act to provide for 12-month continuous enrollment of individuals under the Medicaid program and Childrens Health Insurance Program, and for other purposes; H.R.1791 To amend title XXI of the Social Security Act to permanently extend the Childrens Health Insurance Program, and for other purposes; S.245 SAME Act of 2021; S.1114 A bill to increase vaccination rates among pregnant women enrolled in Medicaid or CHIP, and for other purposes; H.R.2347 To amend title XIX of the Social Security Act to ensure adequate access to vaccines under the Medicaid program and the Vaccines for Children program, and for other purposes; S.1117 A bill to amend title XIX of the Social Security Act to require Medicaid coverage of approved vaccines for pregnant women; S.368 Telehealth Modernization Act; H.R.2125 To amend title XIX and XXI of the Social Security Act to provide coverage of comprehensive tobacco cessation services under such titles, and for other purposes; H.R.1978 To amend title XVIII of the Social Security Act to provide information regarding vaccines for seniors as part of the Medicare & You handbook and to ensure that the treatment of cost sharing for vaccines under Medicare part D is consistent with the treatment of vaccines under Medicare part B, and for other purposes; H.R.2170 To amend title XIX of the Social Security Act to improve access to adult vaccines under Medicaid; H.R.379 Improving Social Determinants of Health Act of 2021; H.R.526 Ensuring Coverage in Public Health Emergencies Act of 2021; H.R.1872 To amend the Patient Protection and Affordable Care Act to provide for Federal Exchange outreach and educational activities, and for other purposes; H.R.1874 To amend the Patient Protection and Affordable Care Act to provide for additional requirements with respect to the navigator program, and for other purposes; H.R.1875 To amend title XXVII of the Public Health Service Act to eliminate the short-term limited duration insurance exemption with respect to individual health insurance coverage; H.R.1878 To amend the Patient Protection and Affordable Care Act to establish a health insurance affordability fund, and for other purposes; H.R.1888 To amend title XIX of the Social Security Act to require a Federal medical assistance percentage of 100 percent for Indian health care providers, and for other purposes; H.R.1890 To amend the Patient Protection and Affordable Care Act to require Exchanges to establish network adequacy standards for qualified health plans and amend the Public Health Service Act to provide protections for consumers against excessive, unjustified, or unfairly discriminatory increases in premium rates; S.104 Improving Social Determinants of Health Act of 2021; S.779 Protecting Americans with Pre-Existing Conditions Act of 2021; S.942 A bill to provide that the rule entitled "Short-Term, Limited Duration Insurance shall have no force or effect; H.R.1790 To amend the Patient Protection and Affordable Care Act to require the Secretary of Health and Human Services to set forth a method of determining maximum out-of-pocket limits and annual updates to premium tax credit eligibility; H.R.550 Immunization Infrastructure Modernization Act of 2021; H.R.736 Community Immunity During COVID-19 Act of 202; H.R.791 Tracking COVID-19 Variants Act; H.R.1268 Building COVID-19 Vaccine Confidence Act of 2021; S.167 Community Immunity During COVID-19 Act of 2021; S.236 Tracking COVID-19 Variants Act; H.R.173 COVID-19 Prevention and Awareness Act of 2021;; H.R.959 Black Maternal Health Momnibus Act of 2021; H.R.3904 Reducing COVID-19 Disparities by Investing in Public Health Act; S.1314 Tobacco Tax Equity Act of 2021; H.R.2786 Tobacco Tax Equity Act of 2021; H.R.1800 Women and Lung Cancer Research and Preventive Services Act of 2021; S.699 Women and Lung Cancer Research and Preventive Services Act of 2021; H.R.1946 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.3749 Katherines Law for Lung Cancer Early Detection and Survival Act of 2021; H.R.3 Elijah E. Cummings Lower Drug Costs Now Act; H.R.1738 Stabilize Medicaid and CHIP Coverage Act; S.646 Stabilize Medicaid and CHIP Coverage Act of 2021; S.1114 Maternal Immunization Enhancement Act; S.1873 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.2125 Quit Because of COVID-19 Act; S.2622 Quit Because of COIVD-19 Act; H.R.2347 Strengthening the Vaccines for Children Program Act of 2021; S.1117 Maternal Immunization Coverage Act; H.R.3149 HEAL for Immigrant Families Act of 2021; H.R.3961 To amend title XIX of the Social Security Act to provide for a demonstration project under the Medicaid program for political subdivisions of States to provide medical assistance for the expansion population under such program, and for other purposes; S.1660 HEAL for Immigrant Families Act of 2021; H.R.2903 CONNECT for Health Act of 2021; S.1512 CONNECT for Health Act of 2021; S.1424 Chronic Disease Management Act of 2021; H.R.3883 To amend title 38, United States Code, to prohibit smoking on the premises of any facility of the Veterans Health Administration, and for other purposes; S.2043 A bill to amend title 38, United States Code, to prohibit smoking on the premises of any facility of the Veterans Health Administration, and for other purposes; S.2315 Medicaid Saves Lives Act; H.R.4595 Medicaid Saves Lives Act; S.Con.Res.14 A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031; H.R.5227 LIFT the BAR Act of 2021; S.674 Public Health Infrastructure Saves Lives Act; Health Equity and Accountability Act; H.R.5030 DIVERSE Trials Act; S.2706 DIVERSE Trials Act; H.R.6302 Protecting the Health of Americas Older Adults Act; S.J.Res.29 A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Department of Labor relating to COVID-19 Vaccination and Testing; Emergency Temporary Standard; S.Res.462 A resolution designating November 2021 as "National Lung Cancer Awareness Month and expressing support for early detection and treatment of lung cancer;; H.R.2909 To amend the Internal Revenue Code of 1986 to allow a one-time election for a qualified charitable distribution to a split-interest entity and to inflation adjust the limits for qualified charitable distributions.; H.R.2954 Securing a Strong retirement Act of 2021; H.R. 7055 Elijah E. Cummings Family Asthma Act; S. 3332 Let States Innovate Under Medicaid Act; S.4348 -FDASLA Act of 2022; H.R.7667 - Food and Drug Amendments of 2022, S.4535 -A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; H.R. 7845 NIH Clinical Trial Diversity Act of 2022; H.R. 8885 Better Health Care Directories Act; S.Res.863 A resolution designating November 2022 as National Lung Cancer Awareness Month and expressing support for early detection and treatment of lung cancer; H.R. 9336 Increasing Access to Lung Cancer Screening Act; H.R. 9565 Comprehensive Cancer Survivorship Act; S. 5295 Comprehensive Cancer Survivorship Act; H.R. 2617 Consolidated Appropriations Act, 2023; S. Amdt.6552 to H.R.2617
Client expense: $40,000 · 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), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, White House Office
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
Issues related to asthma, COPD, influenza, lung cancer, pneumonia, pulmonary fibrosis, tuberculosis and other lung diseases; Issues related to lung disease treatment, prevention and research; Issues related to COVID-19 Response; Issues related to telehealth; Issues related to the SUNSET Rule; Issues related to infrastructure; Issues related to supplemental oxygen; Issues related to health equity; Issues related to FY23 appropriations bills; Issues related to Cancer Moonshot; Issues relating to the Presidents FY24 budget; Issues related to CDC public health workforce and data modernization H.R. 8295 Labor HHS Appropriations bill; H.R.8236 Defense Appropriations bill; S. 4659 Labor HHS Appropriations bill; S. 4663 Defense Appropriations bill; H.R.2140 To prioritize funding for an expanded and sustained national investment in basic science research; S.571 Public Health Funding Prevents Pandemics Act; S.961 A bill to prioritize funding for an expanded and sustained national investment in basic science research; S.962 A bill to prioritize funding for an expanded and sustained national investment in biomedical research; ; H.R.107 Lung Cancer Screening Registry and Quality Improvement Act of 2021; H.R.1800 Women and Lung Cancer Research and Preventive Services Act of 2021; S.699 Women and Lung Cancer Research and Preventive Services Act of 2021; H.R.3 Elijah E. Cummings Lower Drug Costs Now Act; H.R.5030 DIVERSE Trials Act; S.2706 DIVERSE Trials Act; S.Res.462 A resolution designating November 2021 as "National Lung Cancer Awareness Month" and expressing support for early detection and treatment of lung cancer; S.4348 -FDASLA Act of 2022; H.R.7667 - Food and Drug Amendments of 2022, S.4535 -A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; H.R. 7845 NIH Clinical Trial Diversity Act of 2022; S. 5251 Community Mental Wellness and Resilience Act; H.R. 9201 Community Mental Wellness and Resilience Act; S.Res.863 A resolution designating November 2022 as National Lung Cancer Awareness Month and expressing support for early detection and treatment of lung cancer; H.R. 9565 Comprehensive Cancer Survivorship Act; S. 5295 Comprehensive Cancer Survivorship Act; H.R. 2617 Consolidated Appropriations Act, 2023; S. Amdt.6552 to H.R.2617
Client expense: $40,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, White House Office
2022 · fourth_quarter · Pharmacy
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
Client expense: $900,000 · 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 Economic Council (NEC), SENATE
2022 · fourth_quarter · Health Issues
H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products HR 1978 - Protecting Seniors Through Immunization Act H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: DIVERSE Trials Act- Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing, patient assistance H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180); PDUFA provisions related to intellectual property H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 7900: National Defense Authorization Act for Fiscal Year 2023 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse and fentanyl policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Issues related to HFC's Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Notice of Proposed Rulemaking; 340B Drug Pricing Program; Administrative Dispute Resolution; 87 Fed. Reg. 73516 (Nov. 30, 2022) Veterans' Affairs issues related to product sampling Provisions related to the importation of HFCs, necessary for MDI production. P.L.116-260 - AIM Act - EPA Propellant Allowances for metered dose inhaler manufacturing PDUFA riders legislation (Accelerated Approval, Clinical Trial Diversity, Q1Q2)
Client expense: $860,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2022 · fourth_quarter · Health Issues
H.R. 5: Equality Act H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2831: Prompt Approval of Safe Generic Drugs Act - Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 3085: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: DIVERSE Trials Act - Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180) H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 7900: National Defense Authorization Act for Fiscal Year 2023 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1548: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Notice of Proposed Rulemaking; 340B Drug Pricing Program; Administrative Dispute Resolution; 87 Fed. Reg. 73516 (Nov. 30, 2022) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
Client expense: $6,610,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), SENATE
2022 · fourth_quarter · Health Issues
S.56/H.R. 1474 Alzheimer's Caregiver Support Act Americans Giving Care to Elders (AGE) Act of 2021 (H.R. 3689/S. 234) S.104 Improving Social Determinants of Health Act of 2021 National Coronavirus Commission Act of 2021 (H.R. 1306/S. 412) Advancing Connectivity during the Coronavirus to Ensure Support for Seniors (ACCESS) Act (H.R. 596/ S. 57) NIH supplemental funding S.333 COVID-19 Nursing Home Protection Act of 2021 S.962 American Cures Act S.674 Public Health Infrastructure Saves Lives Act FDA Neuroscience Center of Excellence BRAIN Initiative funding PACE Plus Act (S. 1162) Nursing Home Reform Modernization Act (H.R. 1985/ S. 782) Homecare for Seniors Act (H.R. 2898/S. 1399) COVID HCBS Relief Act of 2021 (H.R. 525/S. 151) Long-term care provisions within H.R.1319 the American Rescue Plan Act of 2021 Credit for Caring Act (H.R. 3321/S. 1670) Comprehensive Care for Alzheimer's Act (H.R. 2517/S. 1125) Equity in Neuroscience & Alzheimer's Clinical Trials (ENACT) Act of 2021 (H.R. 3085/S. 1548) Elder Abuse Protection Act of 2021 (H.R. 2922) Reducing COVID-19 Disparities by Investing in Public Health Act (H.R. 3904) PROTECTS Act (S. 2214) Provider Training in Palliative Care Act (S. 2890) Choose Home Care Act of 2021 (S. 2562/H.R 5514) Direct Care Opportunity Act (H.R. 2999) Inflation Reduction Act of 2022 (H.R.5376) Cures 2.0 Act (H.R. 6000) Innovation in Aging Act (S. 3473) Revitalizing the Aging Network Act (S. 3431) Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (S. 2706/H.R. 5030) Stop the Wait Act of 2022 (S. 3575/H.R. 6583) Palliative Care and Hospice Education and Training Act (S. 4260) NAPA Reauthorization Act (H.R. 7775/S. 4203) Alzheimer's Accountability and Investment Act (H.R. 7773/S. 4202) IMPROVE Nursing Homes Act (H.R. 8677) Kevin and Avonte's Reauthorization Act of 2022 (H.R. 8907/S. 4885) Modernizing Accelerated Approval Pathway Act (S. 4446) Mandating Exclusive Review of Individual Treatments (MERIT) Act (H.R. 9127) Access to Innovative Treatments Act of 2022 (H.R. 9358) Consolidated Appropriations Act, 2023 (H.R. 2617) National Concussion Surveillance System (NCSS) funding at the CDC Other matters related to COVID -19 and long COVID Other matters related to elder justice Other matters related to dementia care management models Other matters related to younger-onset Alzheimer's disease Other matters related to Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimers Disease Other matters related to home- and community-based services Other matters related to diversity in clinical trials Other matters related to caregiving Other matters related to biomedical research, Alzheimer's diagnostics, and patient-focused drug development Other matters related to Social Security Other matters related to related to user fee agreements and accelerated approval
Client expense: $490,000 · Firm income: Not reported
Government targets: Administration on Aging, Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), SENATE, Social Security Administration (SSA), Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), White House Office
2022 · fourth_quarter · Health Issues
Inflation Reduction Act of 2022 (PL 117-169) implementation - creating Medicare negotiation of drugs, creating a new inflation rebate under Medicare, limiting insulin copays to $35/month, capping Medicare Part D premium growth, expanding premium and co-pay assistance on prescription drugs for low-income individuals, and capping Medicare out of pocket costs at $2,000 per year, and preventing commercial spillover of maximum fair price into markets beyond Medicare; Consolidated Appropriations Act, 2023 (PL 117-328)- allowing new vaccines to be added to the Vaccine Injury Compensation Fund (VICF), preserving coverage and access to Part D products under EUA; Antibiotics/stewardship; Value of prescription drugs; S. 2076/H.R. 3932, PASTEUR Act of 2021; ACIP recommendations related to pneumococcal vaccines; S. 3700/H.R. 6833, Affordable Insulin Now Act; Issues related to reauthorization of FDA user fee bills (H.R.7667, Food and Drug Amendments of 2022; S. 4348, Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDSLA Act of 2022)), including accelerated approval and reimportation; Issues related to the Public Health Emergency; Issues related to the White House Cancer Moonshot initiative; S. 2706/H.R. 5030, DIVERSE Trials Act; Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act; Executive Order Directing HHS to Explore Additional Actions to Lower Prescription Drug Costs
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Health disparities Access to clinical trials for underrepresented populations Improving Social Determinants of Health Act (S.104/H.R.379) Comprehensive Breast Reconstruction Act of 2021 (H.R. 469) DIVERSE Trials Act (H.R. 5030/S. 2706) Diverse and Equitable Participation in Clinical Trials (DEPICT) Act (H.R.6584); a bill to direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes CURES 2.0 Act (H.R. 6000) Policies related to cancer survivorship Policies related to medications access in during emergencies Polices related to PBM and drug cost transparency Policies related to COVID-19 vaccination distribution Policies impacting immunocompromised people, including COVID-19 vaccination and monoclonal antibody distribution Policies related to reducing the cost of cancer treatment for patients Policies related to decline in breast cancer screenings during the COVID-19 pandemic Policies related to genetic counseling and screening Policies related to reauthorization of user fees at the Food and Drug Administration (H.R. 7667/ S. 4348) H.R. 7845 NIH Clinical Trial Diversity Act; a bill to direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes. H.R. 8185/S. 4440 - Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act; a bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2023 through 2027 Advanced Research Project Agency-Health Act (H.R.5585) Prepare for and Respond to Existing Viruses, Emerging New Threats (PREVENT) Pandemics Act (S.3799) Policies related to the implementation of the Breast Density and Mammography Reporting Act of 2017 H.R. 9565/S. 5295- Comprehensive Cancer Survivorship Act Policies related to the reauthorization of FDA User Fee Agreements Policies related to the implementation of the Breast Density and Mammography Reporting Act of 2017 Policies related to the implementation of the Mammography Quality Standards Act Policies related to administrative actions necessary in breast imaging and breast cancer diagnosis Policies related to the regulation of diagnostic devices Section 1557, Nondiscrimination in Health Programs and Activities (RIN Number 0945-AA17) Request for Information on establishing a National Directory of Healthcare Providers and Services
Client expense: Not reported · Firm income: $40,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE
2022 · fourth_quarter · Health Issues
S.2706, DIVERSE Trials Act and S.3799, PREVENT Pandemics Act -- clinical trial diversity; H.R.2617, Consolidated Appropriations Act, 2023
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Advocate for reducing barriers to entry of generic drugs into the marketplace. Advocate for transparency on the part of pharmaceutical benefit managers. Advocate for patient access to compounded medications. Advocate for reducing the burdens of utilization management tools, including step therapy and prior authorization for pharmaceuticals and services. Advocate for a stable supply of medications and mitigate drug shortages. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H. Res 436, sense of the House supporting state, local and community initiatives to curb incidences of skin cancer beginning with childhood skin cancer. Support H. Res 718, designating October 17, 2021 as National Vitiligo Awareness Day Support H.R. 2163/S. 464, Safe Step Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act Support H.R. 153, Protecting Consumer Access to Generic Drugs Act Support S. 898, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 3662, Patient Access to Urgent-Use Pharmacy Compounding Act Support H.R. 1916/S. 754, Ensuring Lasting Smiles Act Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Advocate for the continued and increased funding of Community Health Centers. Advocate for implementation of surprise medical billing legislation (enacted as part of P.L. 116-260, Consolidated Appropriations Act, 2021, H.R. 133) as intended by Congress. Support H.R. 1677/S. 620, the KEEP Telehealth Options Act. Support H.R. 2903/S. 1512 the CONNECT for Health Act of 2021 Support the Dr. Lorna Breen Health Care Provider Protection Act (S. 610/H.R. 1667). Support H.R. 3173/S. 3018, Improving Seniors Timely Access to Care Act of 2021 Support H.R. 8437, the Improving Seniors Timely Access to Care Act of 2022 Support H.R. 4122/S. 3645, Resident Education Deferred Interest Act or the REDI Act Support the Resident Physician Shortage Reduction Act (S. 834/H.R. 2256) Advocate for the FDA to implement the 2015 rule, General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products; and the Sunlamp Products Proposed; Amendment to Performance Standard, which would ban minors under the age of 18 from using tanning beds. Support H.R. 5054, Keep Physicians Serving Patients Act Support H.R. 5394, the Meaningful Access to Federal Health Plan Claims Data Act Advocate for legislative solution to access problems to iPLEDGE/REMS program for isotretinoin (H.R. 7667, Food and Drug Amendments of 2022/S. 4348 FDASLA Act of 2022, H.R. 2617, Consolidated Appropriations Act). Support H.R. 7649, a bill to direct the Secretary of Health and Human Services to open a public docket for the submission of public comments regarding factors that should be taken into consideration when reviewing a proposed modification to an approved risk evaluation and mitigation strategy, and for other purposes. Support H.R. 5030/S. 2706, the Diversifying Investigations and Equitable Research Studies for Everyone (DIVERSE) Trials Act Support H.R. 7995, GOLD CARD Act of 2022 Advocate to provide relief from the 2% Medicare sequester, replace scheduled and anticipated cuts in payments with positive, inflationary-based updates, eliminate the nearly 4.5% conversion factor cut in the CMS proposed rule for the 2023 Medicare Physician Fee Schedule (MPFS) associated with budget neutrality adjustments tied to Evaluation & Management (E/M) Code MPFS policy changes, and waive the 4% PAYGO sequester to Medicare physician payment reimbursement due to enactment of H.R. 1319, American Recovery Act, P.L. 117-2 (H.R. 2617, Consolidated Appropriations Act). Support H.R. 8800, Supporting Medicare Providers Act of 2022 Advocate against H.R 6708, Improving Access to Workers Compensation for Injured Federal Workers Act, which expands the role of nurse practitioners and physician assistants in providing services to injured federal workers under the federal workers' compensation program. Oppose H.R. 8812, the Improving Care & Access to Nurses Act (I CAN Act)
Client expense: $410,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
Advocate for medical research and prevention funding for the National Institutes of Health and Centers for Disease Control and Prevention via the FY2023 Labor, Health and Human Services, Education and Related Agencies Appropriations bill (H.R. 8295, H.R. 2617)). Support H.R. 5030/S. 2706, the Diversifying Investigations and Equitable Research Studies for Everyone (DIVERSE) Trials Act Advocate for Defense Health Research Programs (CDMRP) in the FY23 Defense Appropriations Act, specifically the Melanoma Research Program (MRP) (H.R. 8236, H.R. 2617).
Client expense: $410,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
Support policies to remove barriers to clinical trials, promote research generally, address issues in childhood cancer research including HR5030 / S2706 - The Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act; HR623 / S1521 - Gabriella Miller Kids First Research Act 2.0; HR3089 / S1544 Accelerating Kids Access to Care Act; HR 6000, CURES 2.0 Act; H.R. 5585, the Advanced Research Project Agency-Health (ARPA-H) Act and reform of the oversight of Laboratory Developed Tests as outlined in S.2209/HR 4128 the VALID Act and S 3799 the PREVENT Pandemics Act.
Client expense: $122,569 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE
2022 · fourth_quarter · Health Issues
Healthcare issues related to clinical laboratories; H.R. 8188/S. 4449, the Saving Access to Laboratory Services Act (SALSA), 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. 4128/S. 2209, the Verifying Accurate Leading-edge IVCT Development (VALID) Act, included as Subtitle C of Title VIII of S. 4348, the FDA Safety and Landmark Advancements Act (FDASLA), provisions relating to FDA oversight of laboratory-developed tests; H.R. 4040, the Advancing Telehealth Beyond COVID-19 Act, H.R. 6202, the Telehealth Extension Act, and H.R. 7573/S. 3593, the Telehealth Extension and Evaluation Act, provisions relating to extension of Medicare coverage of telehealth services and limitations on payment for certain laboratory tests; H.R. 8152, the American Data Privacy and Protection Act (ADPPA), provisions relating to data privacy; S. 3799, the PREVENT Pandemics Act, provisions relating to demographic data reporting obligations for laboratories; H.R. 5030/S. 2706, the DIVERSE Trials Act, provisions relating to enhancing diversity in clinical trials and data collection and reporting by clinical laboratories; H.R. 2565/S. 2952, the FDA Modernization Act, provisions relating to biomedical research; H.R.3173/S. 3018, the Improving Seniors Timely Access to Care Act, provisions relating to prior authorization of health care services; Federal policy related to implementation of the Families First Coronavirus Response Act, Pub. L. 116-127, provisions relating to coverage of and funding for COVID-19 diagnostic tests; Federal policy related to implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Pub. L. 116-136, provisions relating to coverage and reimbursement of COVID-19 diagnostic tests and Medicare reimbursement for clinical laboratory tests; Federal policy related to supply chain issues affecting pre-clinical biomedical research for drug development; Federal policy relating to the National Correct Coding Initiative and manual instructions inconsistent with American Medical Association guidelines for Current Procedural Terminology (CPT) coding; and Federal policy relating to availability of Current Procedural Terminology (CPT) codes.
Client expense: $250,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
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
2022 · fourth_quarter · Health Issues
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
Client expense: $80,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Legislation and regulations affecting medical devices, pharmaceuticals, cosmetics and other consumer products; Coronavirus impact and response; social determinants of health; policies impacting Medicare coverage and reimbursement for prescription drugs; MDUFA Reauthorization; PDUFA Reauthorization; H.R.6000, Cures 2.0 Act; H.R.5030/S.2706, DIVERSE Trials Act; H.R.5585, Advanced Research Project Agency-Health Act; S.3799, PREVENT Pandemics Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.2617, Consolidated Appropriations Act, 2023.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Pharmacy
Provide legislative and regulatory advice related to vaccine development, drug pricing, the 340B Drug Pricing Program, PDUFA Reauthorization, and clinical trial diversity; H.R.6000, Cures 2.0 Act; H.R.5585, Advanced Research Project Agency-Health Act; H.R.5030/S.2706, DIVERSE Trials Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.7559, Prescription Information Modernization Act of 2022; H.R.2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; H.R.2617, Consolidated Appropriations Act, 2023.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES
2022 · fourth_quarter · Health Issues
Bills -H.R. 2163/S. 464 - Safe Step Act -S.1773 - Prescription Drug Pricing Dashboard Act -H.R. 5376 - Build Back Better Act -H.R. 3684- Infrastructure Investment and Jobs Act -H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act -S.2076/H.R. 3932 PASTEUR Act -S. 3799- PREVENT Pandemics Act -H.R.4521 - COMPETES Act of 2022 -S.1260 - United States Innovation and Competition Act of 2021 -H.R.6963 - Accelerated Approval Integrity Act of 2022 -H.R.6996 - Accelerating Access for Patients Act of 2022 -H.R. 2565 / S.2952 the FDA Modernization Act -H.R. 6972 - Give Kids a Chance Act -H.R. 1730 - STAT Act -H.R. 7032 - Increasing Transparency in Generic Drug Applications Act -H.R. 5030/S. 2706 - DIVERSE Trials Act -H.R. 6584 - DEPICT Act -H.R. 9476- Influenza Act of 2022 Issues -Issues related to the 340B Drug Discount Program -Issues relating to drug pricing -Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives -Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars -General education about policies impacting pharmaceutical development, approval, reimbursement and pricing -Issues related to healthcare legislation -Patient access to Part B medicines during the COVID-19 public health emergency -Issues related to health equity, diversity, and inclusion in clinical trials -Issues related to advanced development and procurement of medical countermeasures (MCMs) -Issues related to patient assistance and access -Issues relating to privacy and securing the data of and personal information of consumers -Issues relating to medical research data -Issues relating to screening and diagnostics -Issues related to public health preparedness and response -Issues related to awareness about diabetic eye diseases in minority populations
Client expense: $1,630,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
H.R. 2471 Consolidated Appropriations Act, FY2022 S.2076/H.R. 3932 PASTEUR Act H.R.7667 - Food and Drug Amendments of 2022 S.4348 - FDASLA Act of 2022 H.R.6963 - Accelerated Approval Integrity Act of 2022 H.R.6996 - Accelerating Access for Patients Act of 2022 H.R. 2565 / S.2952 the FDA Modernization Act H.R. 6972 - Give Kids a Chance Act H.R. 1730 - STAT Act H.R. 7032 - Increasing Transparency in Generic Drug Applications Act H.R. 5030/S. 2706 - DIVERSE Trials Act H.R. 6584 - DEPICT Act H.R.3085 - ENACT Act of 2021 -Issues related to public health protection including influenza development and preparedness -Issues related to antimicrobial and antiviral research and product development -Issues related to novel coronavirus and COVID-19 research and product development -Issues related to drug development including PDUFA and Cures 2.0
Client expense: $1,630,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
Health care issues affecting individuals with neuromuscular disease including therapy development, newborn screening, screening and diagnosis, adequate insurance coverage, and access to care. Advocated for the passage of the Newborn Screening Saves Lives Reauthorization Act, H.R. 482 / S. 350, to encourage investment in the national newborn screening program in order to detect more neuromuscular conditions early to speed appropriate interventions for patients. Advocated for robust funding of the national newborn screening program. Advocated for increased funding for National Institutes of Health, Food and Drug Administration, Health Resources and Services Administration, Centers for Disease Control and Prevention, and other health agencies that conduct research on neuromuscular disease and provide services to those with these conditions. Advocated for adequate, affordable, accessible health coverage for individuals with neuromuscular conditions. Advocated for the swift funding and implementation of the ACT for ALS Act (S.1813 and H.R.3537). Advocated for access to healthcare via telemedicine/telehealth throughout and after the COVID-19 public health emergency. Advocated for closure of the Medicaid coverage gap and the permanence of the Advanced Premium Tax Credits as part of the Build Back Better Act. Advocated for a robust paid medical leave program. Advocated for increased funding of home and community-based services (HCBS). Supported the passage of the e Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (H.R. 5030/S. 2706) Advocated for reforms to the FDA Accelerated Approval program as part of the FDA user fee reauthorizations Advocated for the creation of an FDA regulatory pathway for diagnostics, including lab-developed tests and invitro diagnostics. Supported greater appropriations for Consumer Assistance Programs Advocated for the passage of the RARE Act (S. 4185) as part of the Senate FDA User Fee process. Commented on fixing the ACA Family Glitch to the Treasury Department Supported reforms to the HCPCS coding system. Supported passage of the Ending the Diagnostic Odyssey Act Advocated for the passage of the Accelerating Kids Access to Care Act Advocated for certain provisions within the Cures 2.0 Legislation (H.R.6000) Support the passage of the Precision Medicine for Children Act Advocated for the passage of the HCBS Access Act Supported the passage of the Stop the Wait Act (S. 3575 / H.R. 6583) Provided comments to Congress on portions of the Inflation Reduction Act, including the Medicare out-of-pocket cap and smoothing mechanisms. Joined coalition comments on the CY 2023 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies Proposed Rule. Provided policy suggestions to CMS on the annual Notice of Benefit and Payment Parameters. Advocated for greater coverage of seat elevation systems and standing wheelchairs within the Medicare program. Advocated for the Access to Genetic Counselors Act
Client expense: $200,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Natl Council on Disability, Natl Institutes of Health (NIH), SENATE, Treasury, Dept of
2022 · third_quarter · Medical/Disease Research/Clinical Labs
Advocated in favor of robust appropriations funding for the National Institutes of Health, the Food and Drug Administration, the Health Resources and Services Administration, and the Centers for Disease Control and Prevention. Advocated for greater appropriations for the National Center for Advancing Translational Sciences (NCATS) Advocated for greater appropriations for the National Institutes of Health. Advocated for appropriations for HHS, NIH, and FDA to implement the ACT for ALS. Advocated for the passage of the Newborn Screening Saves Lives Reauthorization Act, H.R. 482 / S. 350, to encourage investment in the national newborn screening program in order to detect more neuromuscular conditions early to speed appropriate interventions for patients. Supported the passage of the e Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (H.R. 5030/S. 2706) Advocated for reforms to the FDA Accelerated Approval program as part of the FDA user fee reauthorizations Advocated for the creation of an FDA regulatory pathway for diagnostics, including lab-developed tests and invitro diagnostics. Advocated for the passage of the RARE Act (S. 4185) as part of the Senate FDA User Fee process. Advocated for certain provisions within the Cures 2.0 Legislation (H.R.6000) Advocated for passage of FDA and clinical trial reforms within an end-of-year bill, including accelerated approval reforms, clinical trial diversity advancements, the RARE Act, reauthorization of the Orphan Product Grants Program, and more.
Client expense: $200,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
2022 · third_quarter · Pharmacy
Advocated for funding and implementation of the ACT for ALS, a law that should accelerate development of treatments for individuals with ALS and other neuromuscular diseases. Advocated for the passage of the Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (H.R. 5030/S. 2706) Supported passage of the Ending the Diagnostic Odyssey Act Advocated for the passage of the Accelerating Kids Access to Care Act Advocated for certain provisions within the Cures 2.0 Legislation (H.R.6000) Support the passage of the Precision Medicine for Children Act Advocated for reforms to the FDA Accelerated Approval program as part of the FDA user fee reauthorizations Advocated for the creation of an FDA regulatory pathway for diagnostics, including lab-developed tests and invitro diagnostics. Advocated for passage of FDA and clinical trial reforms within an end-of-year bill, including accelerated approval reforms, clinical trial diversity advancements, the RARE Act, reauthorization of the Orphan Product Grants Program, and more.
Client expense: $200,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
Issues relating to access to care, health disparities, childhood cancer, quality of life and palliative care, cancer survivorship, federal health care programs, genetic information, cancer, nutrition, tanning beds, clinical trials, skin cancer, cannabis research, and wellness, including: The Inflation Reduction Act, HR 5376 - extension of expanded tax credits for ACA marketplaces; HR 1550, The Prevent HPV Cancers Act S. 699, Women and Lung Cancer Research and Preventive Services Act of 2021 HR 623, Gabriella Miller Kids First Research Act 2.0 S. 4260, The Palliative Care and Hospice Education and Training Act Provider Training in Palliative Care Act, S 2890 Issues related to the possible introduction of the 21st Century Cures Act version 2.0 Regulations implementing the No Suprises Act Proposed Rule on Affordability of Employer Coverage for Family Members of Employees, REG-114339-21 Regulations related to short term limited duration health insurance plans (upcoming) OMB RFI on health equity - comments DICT RFI - Eshoo DICT Ancillary Costs legislation/Menendez, Scott, Smith, Young, Ruiz House/Senate Appropriations Committee FDA DICT report language Reducing Hereditary Cancer Act of 2021 - DWS, Slotkin, Miller-Meeks, and Davis Personal Care Products Safety Act - Feinstein, Collins H.R. 6638 - Reducing COVID-19 Disparities by Investing in Public Health Act of 2021 The VALID Act - DeGette, Bennet, Burr, Buschon DIVERSE Trials Act - H.R.5030/ S.2706 DEPICT Act, HR 6584 Give Kids a Chance Act, H.R. 6972 NIH Clinical Trials Diversity Act, HR 7845 HR 7667, Food and Drug Amendments Act Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, S 4348 S. 4185, the Retaining Access and Restoring Exclusivity (RARE) Act Potential legislation on cancer survivorship being developed by Rep. Wasserman Schultz Health Equity and Accountability Act, HR 7585 Notice of Benefit and Payment Parameters, regulatory comments Regulatory issues related to healthy food and dietary guidelines
Client expense: $1,200,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, White House Office
2022 · third_quarter · Medical/Disease Research/Clinical Labs
DIVERSE Trials Act, HR 5030/S 2706 HR 623, Gabriella Miller Kids First Research Act 2.0 Issues related to the possible introduction of the 21st Century Cures Act version 2.0 DICT RFI - Eshoo DICT Ancillary Costs legislation/Menendez, Scott, Smith, Young, Ruiz House/Senate Appropriations Committee FDA DICT report language DEPICT Act, HR 6584 NIH Clinical Trials Diversity Act, HR 7845 HR 7667, Food and Drug Amendments Act Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, S 4348
Client expense: $1,200,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, White House Office
2022 · third_quarter · Health Issues
H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; General issues related to drug pricing; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act; H.R. 7667 - Food and Drug Amendments of 2022; S.4348 - FDASLA Act of 2022 H.R. 7845 - NIH Clinical Trial Diversity Act of 2022; H.R 7032 - Increasing Transparency in Generic Drug Applications Act of 2022; H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot Prescription Drug User Fee Act (PDUFA) H.R. 4128/S. 2209, VALID Act S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 Pharmaceutical Innovation, generally;
Client expense: $930,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, White House Office
2022 · third_quarter · Health Issues
H.R. 379/S. 104 - Improving Social Determinants of Health Act; bill to require the Centers for Disease Control and Prevention (CDC) to establish a program to improve health outcomes and reduce health inequities by, for example, coordinating activities across the CDC. As part of the program, the CDC must award grants to eligible organizations to build capacity to address social determinants of health. H.R. 469 - Comprehensive Breast Reconstruction Act of 2021; bill provides for Medicare, Medicaid, and private health insurance coverage of certain tattooing services in connection with post-mastectomy breast reconstruction, and aligns the scope of Medicare and Medicaid coverage of such breast reconstruction with that of private health insurance. H.R. 5030/S.2706 - DIVERSE Trials Act; A bill to require FDA to issue guidance on decentralized clinical trials to promote meaningful demographic/geographic diversity in patient engagment, expand reporting by laboratories that test for and diagnose COVID-19, and require a study on data collection and data sharing during public health emergencies H.R. 6000 - Cures 2.0 Act; a comprehensive healthcare and biomedical research bill H.R. 4794/S. 2533 - Making Advances in Mammography and Medical Options for Veterans Act; a bill to improve mammography services furnished by the Department of Veterans Affairs H.R. 4571/S. 2102 - Supporting Expanded Review for Veterans in Combat Environments (SERVICE) Act of 2021; a bill to expand eligibility for Veterans Health Administration mammography screenings to veterans who served in certain locations during specified periods, including those who were exposed to toxic substances at such locations H.R. 6584 - Diverse and Equitable Participation in Clinical Trials (DEPICT) Act; a bill to direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes. S. 3799 - Prepare for and Respond to Existing Viruses, Emerging New Threats, (PREVENT) and Pandemics Act; a bill to prepare for, and respond to, existing viruses, emerging new threats, and pandemics. Efforts to introduce a bill regarding clinical trial diversity nicknamed the The Clinical Trial Diversity Act H.R. 7845 NIH Clinical Trial Diversity Act; a bill to direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes. H.R. 8185/S. 4440 - Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act; a bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2023 through 2027 S. 4260 - Palliative Care and Hospice Education and Training Act; a bill to increase the number of permanent faculty in palliative care at accredited allopathic and osteopathic medical schools, nursing schools, social work schools, and other programs, including physician assistant education programs, to promote education and research in palliative care and hospice, and to support the development of faculty careers in academic palliative medicine. H.R. 7667/S. 4348 - Food and Drug Amendments of 2022; a bill to reauthorize Food and Drug Administration (FDA) user fee programs for certain drugs and devices, establishes requirements to increase diversity in clinical trials, and modifies requirements relating to the overall supply chain for drugs and devices. Policies related to telehealth Policies related to COVID-19 vaccination and monoclonal antibody distribution Policies to increase clinical trial diversity and access for underrepresented populations Policies related to genetic counseling and testing Policies related to cancer survivorship Policies related to PBM and drug cost transparency Policies related to the reauthorization of FDA User Fee Agreements Policies related to the implementation of the Breast Density and Mammography Reporting Act of 2017
Client expense: $50,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE
2022 · third_quarter · Medical/Disease Research/Clinical Labs
DIVERSE Trials Act, HR 5030/S 2706 HR 623, Gabriella Miller Kids First Research Act 2.0 Issues related to the possible introduction of the 21st Century Cures Act version 2.0 DICT RFI - Eshoo DICT Ancillary Costs legislation/Menendez, Scott, Smith, Young, Ruiz House/Senate Appropriations Committee FDA DICT report language DEPICT Act, HR 6584 NIH Clinical Trials Diversity Act, HR 7845 HR 7667, Food and Drug Amendments Act Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, S 4348
Client expense: $1,200,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, White House Office
2022 · third_quarter · Health Issues
Issues relating to access to care, health disparities, childhood cancer, quality of life and palliative care, cancer survivorship, federal health care programs, genetic information, cancer, nutrition, tanning beds, clinical trials, skin cancer, cannabis research, and wellness, including: The Inflation Reduction Act, HR 5376 - extension of expanded tax credits for ACA marketplaces; HR 1550, The Prevent HPV Cancers Act S. 699, Women and Lung Cancer Research and Preventive Services Act of 2021 HR 623, Gabriella Miller Kids First Research Act 2.0 S. 4260, The Palliative Care and Hospice Education and Training Act Provider Training in Palliative Care Act, S 2890 Issues related to the possible introduction of the 21st Century Cures Act version 2.0 Regulations implementing the No Suprises Act Proposed Rule on Affordability of Employer Coverage for Family Members of Employees, REG-114339-21 Regulations related to short term limited duration health insurance plans (upcoming) OMB RFI on health equity - comments DICT RFI - Eshoo DICT Ancillary Costs legislation/Menendez, Scott, Smith, Young, Ruiz House/Senate Appropriations Committee FDA DICT report language Reducing Hereditary Cancer Act of 2021 - DWS, Slotkin, Miller-Meeks, and Davis Personal Care Products Safety Act - Feinstein, Collins H.R. 6638 - Reducing COVID-19 Disparities by Investing in Public Health Act of 2021 The VALID Act - DeGette, Bennet, Burr, Buschon DIVERSE Trials Act - H.R.5030/ S.2706 DEPICT Act, HR 6584 Give Kids a Chance Act, H.R. 6972 NIH Clinical Trials Diversity Act, HR 7845 HR 7667, Food and Drug Amendments Act Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, S 4348 S. 4185, the Retaining Access and Restoring Exclusivity (RARE) Act Potential legislation on cancer survivorship being developed by Rep. Wasserman Schultz Health Equity and Accountability Act, HR 7585 Notice of Benefit and Payment Parameters, regulatory comments Regulatory issues related to healthy food and dietary guidelines
Client expense: $1,200,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, White House Office
2022 · third_quarter · Medical/Disease Research/Clinical Labs
Support policies to remove barriers to clinical trials, promote research generally, address issues in childhood cancer research including HR5030 / S2706 - The Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act; HR623 / S1521 - Gabriella Miller Kids First Research Act 2.0; HR3089 / S1544 Accelerating Kids Access to Care Act; HR 6000, CURES 2.0 Act; H.R. 5585, the Advanced Research Project Agency-Health (ARPA-H) Act and reform of the oversight of Laboratory Developed Tests as outlined in S.2209/HR 4128 the VALID Act and S 3799 the PREVENT Pandemics Act.
Client expense: $140,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE
2022 · third_quarter · Health Issues
H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R.1978 - Protecting Seniors Through Immunization Act of 2021 H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: DIVERSE Trials Act- Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research S. 581/H.R. 2170: HAPI Act; Medicaid financial barriers HR 5605 PrEP Assistance Act H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022 H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 8152: American Data Privacy and Protection Act H.R. 5376 Inflation Reduction Act - provisions related to vaccines and pharmaceuticals H.R. 4127: DISARM Act Act Provisions related to antimicrobial drug development H.R. 3932/S. 2076: PASTEUR Act - authorizes the Department of Health and Human Services (HHS) to enter into subscription contracts for critical-need antimicrobial drugs. H.R. 3655: Vaccine Injury Compensation Modernization Act H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) S. 912/H.R. 1978: Protecting Seniors Through Immunization Act H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Dietary Supplement Health and Education Act Reform Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse and fentanyl policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues High deductible health plans/HSA and FSA for dietary supplements policy issues Final Rule; Importation of Prescription Drugs Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act CREATES/USICA INFORM Consumers Act SHOP SAFE Act Food and Drug Amendments of 2022 Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Veterans' Affairs issues related to product sampling Senate Amendment to H.R. 3684, Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates H.R. 4121, PRO Seniors Act, provisions related to drug rebates Protecting American Innovation Act, provisions related to intellectual property
Client expense: $1,390,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2022 · third_quarter · Health Issues
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
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · third_quarter · Health Issues
H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act; all provisions of the bill H.R. 4390: Preserving Rules Ordered for The Entities Covered Through (PROTECT) 340B Act of 2021; all provisions of the bill H.R. 5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act; all provisions of the bill H.R. 6000: Cures 2.0 Act; all healthcare provisions of the bill H.R. 6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act; all provisions of the bill H.R. 6833: Affordable Insulin Now Act; provisions related to the Prescription Drug User Fee Act Reauthorization H.R. 6963: Accelerated Approval Integrity Act of 2022; all provisions of the bill H.R. 6996: Accelerating Access for Patients Act of 2022; all provisions of the bill H.R. 7667: Food and Drug Amendments of 2022; provisions related to drug development user fees S. 2706: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act; all provisions of the bill S. 4348: Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022; provisions related to drug development user fees S. 4535: Food and Drug Administration Simple Reauthorization (FDASRA) Act of 2022; provisions related to drug development user fees 2021 Notice of Benefit and Payment Parameters Proposed Rule - 340B Drug Pricing Program policy issues P.L. 117-169 (H.R. 5376): Inflation Reduction Act of 2022; all provisions of the bill General healthcare issues surrounding the COVID-19 pandemic General issues surrounding healthcare supply chain General discussions regarding drug cost and pricing policy issues General discussions related to the Cancer Moonshot Initiative and the Advanced Research Projects Agency for Health (ARPA-H) General discussion related to the Prescription Drug User Fee Act Reauthorization
Client expense: $530,000 · 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