Patients’ Right to Know Their Medication Act of 2023

Retention of FDA regulations mandating use of pharmaceutical information and prescriber data on paper. Support of H.R. 1173 (118th Congress): Patients Right to Know Their Medication Act.

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Chronic Care Management Improvement Act of 2023 (H.R.2829) Removes cost-sharing responsibilities for CCM services under the Medicare program. Rural Health Innovation Act of 2023 (S.953 and H.R.1712) Creates grant programs under HRSA to expand urgent/triage care in rural communities (RHCs and FQHCs eligible); $500,000 for existing facilities and $750,000 for new facilities. Rural America Health Corps Act (S.940) Creates a loan repayment program called NHSC Rural Provider Loan Repayment Program; includes NPs and PAs as providers eligible for the program; specifically aimed at rotating graduates through underserved areas. Save Americas Rural Hospitals (H.R.833) Primarily hospital related but Sec.113 makes permanent Medicare telehealth in RHCs/FQHCs and allows for telehealth visits to be reimbursed at parity with in-person visits. Home-Based Telemental Health Care Act of 2023 (S.1077) Grant demonstration program through USDA for increasing mental health and substance abuse services in rural, medically underserved populations. Patients' Right to Know Their Medication Act of 2023 (H.R.1173) RPM Cost Sharing Elimination Study Act of 2023 (H.R.6801) Primary Care Team Education Centers Act Creates further investment in the establishment of clinical training sites for primary care providers. RHCs would be eligible entities for this funding. Improving Seniors Timely Access to Care Act Modernize Medicare Advantage prior authorization processes. Rural Residency Planning and Development Act of 2024 Officially authorizes the RRPD program that has been around since 2019. RHCs are eligible entities for participation in RRPD programs. Improving Measurements for Loneliness and Isolation Act of 2023 (H.R.6284) Create a working group within the Department of Health and Human Services tasked with developing standards to measure loneliness and isolation, with the goal of tackling this growing issue. Promoting Effective and Empowering Recovery Services Under the Medicare Program (H.R.6748/S.3498) Provides for Medicare coverage of peer support services as RHC services. Physical Therapist Workforce and Patient Access Act of 2023 (H.R.4829) Establishes physical therapy services as RHC services (reimbursable at RHC AIR) Rural Health Preceptor Tax Fairness Act (H.R.8738) Creates a $1,000 tax credit for health preceptors of various health professionals in rural areas. Kid Proof Act (S.3364/H.R. 6663) Strengthening Pathways to Health Professions Act (H.R. 10280)

Client expense: Not reported · Firm income: $90,000

H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R. 2679, the Pharmacy Benefits Manager Accountability Act; H.R. 3008, the Drug Shortage Prevention Act; S. 1339, the Pharmacy Benefits Manager Reform Act; S. 1542 / H.R. 6283, the Delinking Revenue from Unfair Gouging Act; H.R. 1173, the Patients Right to Know Their Medication Act of 2023; Proposed rule for Medication Guides: Patient Medication Information (Docket No. FDA-2019-N-5959); Implementation of Public Law 113-54, the Drug Quality and Security Act; Draft Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act, (Docket No. FDA-2015-D-3517); H.R. 5400 / S. 2436, the NO PBMs Act; S.3430,the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023; Request for Information for "Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act" (Docket No. FDA-2023-N-4806); Request for Information on Bipartisan 340B Senate Working Group SUSTAIN 340B Act Discussion Draft; H.R.4366, the Consolidated Appropriations Act, 2024; H.R.2882, the Further Consolidated Appropriations Act, 2024; Comments on implementation and enforcement of recent changes to USP Chapter <797>, regarding the Compounded Sterile Preparations (CSPs) in Category 3 to the FDA; Comments to FDA on "Agency Information Collection Activities; Proposed Collection; Comment Request; Proposed Small Dispensers Assessment Under the Drug Supply Chain Security Act" [Docket No.FDA-2024-N-0668]; Comments to FDA on " Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act"[Docket No. FDA-2023-N-0061]; H.R.9096, the Pharmacists Fight Back Act; Comments to FDA on Docket No. FDA-2023-N-4806 - Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket; Request for Information and Comment. Comments to FDA on "Pharmacy Compounding Advisory Committee's Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List Revisions to the Withdrawn or Removed List [Docket No. FDA-2024-N-4188]"; Comment to FDA on "Pharmaceutical Distribution Supply Chain; Drug Supply Chain Security" [Docket No. FDA-2024-N-3675]; Comment to FDA on "Opposition to Novo Nordisk and Eli Lillys Requests to Place GLP-1 Medications on the Demonstrably Difficult to Compound List" [Docket No. FDA-2015-N-0030]; H.R.10239/S.5368,the Ending Drug Shortages Act; H.R.10362, the PBM Act of 2024; H.R.10545, the American Relief Act, 2025;

H.R. 1503, Prescription Information Modernization Act of 2023, regarding all provisions. H.R. 1173, Patients Right to Know Their Medication Act of 2023, regarding all provisions. Issues surrounding e-label appropriations policy rider.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Promoting continued access to pharmaceutical printed packaging information, including promotion for H.R. 1173, the Patients' Right to Know Their Medication Act of 2023, and FDA's proposed PMI rule.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Practice Support/Grants to Practice H.R. 10331, Anesthesia for All Act: prohibit time caps on reimbursement for anesthesia services H.R.1173, Patients Right to Know Their Medication Act of 2023: prescription drug labeling H.R. 9572, No Surprises Enforcement Act: strengthen compliance with the No Surprises Act S.3548, Health Care Prices Revealed and Information to Consumers Explained Transparency Act: Ambulatory Surgical Centers H.R.6205, Healthcare Workforce Resilience Act: physician workforce H.R.7591, National Patient Safety Board Act of 2024: patient safety S.1302, Resident Physician Shortage Reduction Act of 2023: residency positions S.665, Conrad State 30 and Physician Access Reauthorization Act: Foreign physician immigration status Medical liability H.Res. 734: Expressing support for the designation of October 1 as "National Latino and Latina Physician Day" S. 705, Specialty Physicians Advancing Rural Care (SPARC) Act: physician shortages in rural areas Public Law No. 113-5, Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA): preparedness for public health Lorna Breen Reauthorization H.R. 3259, NOPAIN Act: Opioids S. 586, NOPAIN Act: Opioids S. 1292, Non-Opioid Directive Act: Opioids H.R. 7961, SAVE Act: To protect hospital personnel from violence, and for other purposes. H.R.833, Save America's Rural Hospitals: rural pass through H.R. 7725, Embracing anti-Discrimination, Unbiased Curricula, and Advancing Truth in Education (EDUCATE) Act: medical school funding H.R. 2671, Specialty Physicians Advancing Rural Care Act (the SPARC Act): student loan repayment programs to support specialty medical care in rural areas Pre-authorization; prior authorization Affordable Care Act reform efforts 42 CFR Part 2, Confidentiality of Substance Use Disorder Patient Records: appropriate access to patient information essential for providing whole-person care Resident Education Deferred Interest Act (REDI Act): Student loan relief Student Loan Forgiveness for Frontline Health Workers Act: Student loan relief 21st Century Cures Initiative H.R. 4369, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act: Drug shortages DEA Scheduling Propofol Comparative Effectiveness Research - PCORI HITECH Implementation, Electronic Health Records, Final and Proposed Rules, HIT Meaningful Use HHS/OIG Anesthesia Practice Arrangements, Company Model FDA Safe Use Initiative Pain Management Anesthesia Research Funding (Pediatric and others) Scope of Practice FDA Operating Room Fires Naloxone FDA Opioids Ketamine use by law enforcement Prescription Drug Abuse FDA Network of Experts NIH Interagency Pain Research Coordinating Committee USP - US Pharmacopeia National Pain Strategy Nondiscrimination Compounding FDA Nominations to Advisory Committees (Anesthesia Drugs, Anesthesia Devices, Compounding) Agency for Healthcare Research and Quality (AHRQ) funding Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Brain health Certified Anesthesiologist Assistants Blood management Long COVID research Anesthesia workforce shortages CDC Opioid Prescribing Guideline 2024 Labor/HHS/Education appropriations bill Defense Health Agency anesthesia policy Maternal Mortality/Maternal Care Deserts Change Healthcare, Change Healthcare data breach Insurance reform, shared savings, insurer accountability

H.R. 1503, Prescription Information Modernization Act of 2023, regarding all provisions. H.R. 1173, Patients Right to Know Their Medication Act of 2023, regarding all provisions. Issues surrounding e-label appropriations policy rider.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Chronic Care Management Improvement Act of 2023 (H.R.2829) Removes cost-sharing responsibilities for CCM services under the Medicare program. Rural Health Innovation Act of 2023 (S.953 and H.R.1712) Creates grant programs under HRSA to expand urgent/triage care in rural communities (RHCs and FQHCs eligible); $500,000 for existing facilities and $750,000 for new facilities. Rural America Health Corps Act (S.940) Creates a loan repayment program called NHSC Rural Provider Loan Repayment Program; includes NPs and PAs as providers eligible for the program; specifically aimed at rotating graduates through underserved areas. Save Americas Rural Hospitals (H.R.833) Primarily hospital related but Sec.113 makes permanent Medicare telehealth in RHCs/FQHCs and allows for telehealth visits to be reimbursed at parity with in-person visits. Home-Based Telemental Health Care Act of 2023 (S.1077) Grant demonstration program through USDA for increasing mental health and substance abuse services in rural, medically underserved populations. Patients' Right to Know Their Medication Act of 2023 (H.R.1173) RPM Cost Sharing Elimination Study Act of 2023 (H.R.6801) Primary Care Team Education Centers Act Creates further investment in the establishment of clinical training sites for primary care providers. RHCs would be eligible entities for this funding. Improving Seniors Timely Access to Care Act Modernize Medicare Advantage prior authorization processes. Rural Residency Planning and Development Act of 2024 Officially authorizes the RRPD program that has been around since 2019. RHCs are eligible entities for participation in RRPD programs. Improving Measurements for Loneliness and Isolation Act of 2023 (H.R.6284) Create a working group within the Department of Health and Human Services tasked with developing standards to measure loneliness and isolation, with the goal of tackling this growing issue. Promoting Effective and Empowering Recovery Services Under the Medicare Program (H.R.6748/S.3498) Provides for Medicare coverage of peer support services as RHC services. Physical Therapist Workforce and Patient Access Act of 2023 (H.R.4829) Establishes physical therapy services as RHC services (reimbursable at RHC AIR) Rural Health Preceptor Tax Fairness Act (H.R.8738) Creates a $1,000 tax credit for health preceptors of various health professionals in rural areas.

H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R. 2679, the Pharmacy Benefits Manager Accountability Act; H.R. 3008, the Drug Shortage Prevention Act; S. 1339, the Pharmacy Benefits Manager Reform Act; S. 1542 / H.R. 6283, the Delinking Revenue from Unfair Gouging Act; H.R. 1173, the Patients Right to Know Their Medication Act of 2023; Proposed rule for Medication Guides: Patient Medication Information (Docket No. FDA-2019-N-5959); Implementation of Public Law 113-54, the Drug Quality and Security Act; Draft Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act, (Docket No. FDA-2015-D-3517); H.R. 5400 / S. 2436, the NO PBMs Act; S.3430,the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023; Request for Information for "Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act" (Docket No. FDA-2023-N-4806); Request for Information on Bipartisan 340B Senate Working Group SUSTAIN 340B Act Discussion Draft; H.R.4366, the Consolidated Appropriations Act, 2024; H.R.2882, the Further Consolidated Appropriations Act, 2024; Comments on implementation and enforcement of recent changes to USP Chapter <797>, regarding the Compounded Sterile Preparations (CSPs) in Category 3 to the FDA; Comments to FDA on "Agency Information Collection Activities; Proposed Collection; Comment Request; Proposed Small Dispensers Assessment Under the Drug Supply Chain Security Act" [Docket No.FDA-2024-N-0668]; Comments to FDA on " Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act"[Docket No. FDA-2023-N-0061]; H.R.9096, the Pharmacists Fight Back Act; Comments to FDA on Docket No. FDA-2023-N-4806 - Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket; Request for Information and Comment.

Retention of FDA regulations mandating use of pharmaceutical information and prescriber data on paper. Support of H.R. 1173 (118th Congress): Patients Right to Know Their Medication Act.

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Promoting continued access to pharmaceutical printed packaging information, including promotion for H.R. 1173, the Patients' Right to Know Their Medication Act of 2023, and FDA's proposed PMI rule.

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

H.R. 1503, Prescription Information Modernization Act of 2023, regarding all provisions. H.R. 1173, Patients Right to Know Their Medication Act of 2023, regarding all provisions. Issues surrounding e-label appropriations policy rider.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R. 2679, the Pharmacy Benefits Manager Accountability Act; H.R. 3008, the Drug Shortage Prevention Act; S. 1339, the Pharmacy Benefits Manager Reform Act; S. 1542 / H.R. 6283, the Delinking Revenue from Unfair Gouging Act; H.R. 1173, the Patients Right to Know Their Medication Act of 2023; Proposed rule for Medication Guides: Patient Medication Information (Docket No. FDA-2019-N-5959); Implementation of Public Law 113-54, the Drug Quality and Security Act; Draft Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act, (Docket No. FDA-2015-D-3517); H.R. 5400 / S. 2436, the NO PBMs Act; S.3430,the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023; Request for Information for "Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act" (Docket No. FDA-2023-N-4806); Request for Information on Bipartisan 340B Senate Working Group SUSTAIN 340B Act Discussion Draft; H.R.4366, the Consolidated Appropriations Act, 2024; H.R.2882, the Further Consolidated Appropriations Act, 2024; Comments on implementation and enforcement of recent changes to USP Chapter <797>, regarding the Compounded Sterile Preparations (CSPs) in Category 3 to the FDA; Comments on "Agency Information Collection Activities; Proposed Collection; Comment Request; Proposed Small Dispensers Assessment Under the Drug Supply Chain Security Act" [Docket No.FDA-2024-N-0668]; Comments on " Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act"[Docket No. FDA-2023-N-0061];

Promoting continued access to pharmaceutical printed packaging information, including promotion for H.R. 1173, the Patients' Right to Know Their Medication Act of 2023, and FDA's proposed PMI rule.

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Retention of FDA regulations mandating use of pharmaceutical information and prescriber data on paper. Support of H.R. 1173 (118th Congress): Patients Right to Know Their Medication Act.

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R. 2679, the Pharmacy Benefits Manager Accountability Act; H.R. 3008, the Drug Shortage Prevention Act; S. 1339, the Pharmacy Benefits Manager Reform Act; S. 1542 / H.R. 6283, the Delinking Revenue from Unfair Gouging Act; H.R. 1173, the Patients Right to Know Their Medication Act of 2023; Proposed rule for Medication Guides: Patient Medication Information (Docket No. FDA-2019-N-5959); Implementation of Public Law 113-54, the Drug Quality and Security Act; Draft Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act, (Docket No. FDA-2015-D-3517); H.R. 5400 / S. 2436, the NO PBMs Act; S.3430,the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023; Request for Information for "Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act" (Docket No. FDA-2023-N-4806); Request for Information on Bipartisan 340B Senate Working Group SUSTAIN 340B Act Discussion Draft; H.R.4366, the Consolidated Appropriations Act, 2024; H.R.2882, the Further Consolidated Appropriations Act, 2024;

Client expense: $320,000 · Firm income: Not reported

H.R. 1503, Prescription Information Modernization Act of 2023, regarding all provisions. H.R. 1173, Patients Right to Know Their Medication Act of 2023, regarding all provisions. Issues surrounding e-label appropriations policy rider.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Retention of FDA regulations mandating use of pharmaceutical information and prescriber data on paper. Support of H.R. 1173 (118th Congress): Patients Right to Know Their Medication Act.

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Promoting continued access to pharmaceutical printed packaging information, including promotion for H.R. 1173, the Patients' Right to Know Their Medication Act of 2023, and H.R. 1503, and FDA's proposed PMI rule.

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

H.R. 1503, Prescription Information Modernization Act of 2023, regarding all provisions. H.R. 1173, Patients Right to Know Their Medication Act of 2023, regarding all provisions. Issues surrounding e-label appropriations policy rider. Seek amendment to the NDAA to require printed prescription inserts be attached to drug packaging.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R. 382, the Pandemic is Over Act; H.R. 2679, the Pharmacy Benefits Manager Accountability Act; H.R. 3008, the Drug Shortage Prevention Act; S. 1339, the Pharmacy Benefits Manager Reform Act; S. 1542 / H.R. 6283, the Delinking Revenue from Unfair Gouging Act; H.R. 5142, the Vaccine Injury Compensation Modernization Act of 2023; H.R. 5143, the Vaccine Access Improvement Act of 2023; S. 2305, the Biosimilar Red Tape Elimination Act; H.R. 1173, the Patients Right to Know Their Medication Act of 2023; Proposed rule for Medication Guides: Patient Medication Information (Docket No. FDA-2019-N-5959); Implementation of Public Law 113-54, the Drug Quality and Security Act; Draft Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act, (Docket No. FDA-2015-D-3517); H.R. 5400 / S. 2436, the NO PBMs Act; S.3430,the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023

Client expense: $330,000 · Firm income: Not reported

H.R. 1503, Prescription Information Modernization Act of 2023, regarding all provisions. H.R. 1173, Patients Right to Know Their Medication Act of 2023, regarding all provisions. Issues surrounding e-label appropriations policy rider. Seek amendment to the NDAA to require printed prescription inserts be attached to drug packaging.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R. 382, the Pandemic is Over Act; H.R. 2679, the Pharmacy Benefits Manager Accountability Act; H.R. 3008, the Drug Shortage Prevention Act; S. 1339, the Pharmacy Benefits Manager Reform Act; S. 1542, the Delinking Revenue from Unfair Gouging Act; H.R. 5142, the Vaccine Injury Compensation Modernization Act of 2023; H.R. 5143, the Vaccine Access Improvement Act of 2023; S. 2305, the Biosimilar Red Tape Elimination Act; H.R. 1173, the Patients Right to Know Their Medication Act of 2023; Proposed rule for Medication Guides: Patient Medication Information (Docket No. FDA-2019-N-5959); Implementation of Public Law 113-54, the Drug Quality and Security Act

Client expense: $360,000 · 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), SENATE

H.R. 1503, Prescription Information Modernization Act of 2023, regarding all provisions. H.R. 1173, Patients Right to Know Their Medication Act of 2023, regarding all provisions. Issues surrounding e-label appropriations policy rider. Seek amendment to the NDAA to require printed prescription inserts be attached to drug packaging.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1503, Prescription Information Modernization Act of 2023, regarding all provisions. H.R. 1173, Patients Right to Know Their Medication Act of 2023, regarding all provisions. Issues surrounding e-label appropriations policy rider

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE