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Lower Costs, More Cures Act of 2021
Legislative Progress
Introduced
April 21, 2021
Latest Action
October 19, 2021
Primary Sponsor
Cathy McMorris RodgersRepublican(WA)
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
87pct
181d open
vs 9,698 other HR bills in the 117th — cohort avg 63d
Lower Costs, More Cures Act of 2021 This bill establishes and modifies several programs and requirements to address prescription drug prices. The bill modifies provisions under Medicare and Medicaid relating to prescription drug coverage and price transparency. Among other changes, the bill requires the Centers for Medicare & Medicaid Services to publish certain information, as reported by pharmacy benefit managers (PBMs), relating to generic dispensing rates, drug discounts and rebates, and payments between PBMs, health plans, and pharmacies; caps annual out-of-pocket spending under the Medicare prescription drug benefit; allows prescription drug plan sponsors under the Medicare prescription drug benefit to offer additional plans in a region; requires pass-through pricing models, and prohibits spread-pricing, for payment arrangements with PBMs under Medicaid; and allows states to include in the Medicaid Drug Rebate Program covered outpatient drugs that are provided as part of physician or outpatient hospital services. The bill also generally modifies other provisions relating to the regulation and costs of generic and brand-name drugs. Among other changes, the bill prohibits the manufacturer of a brand-name, generic, or biosimilar drug from entering into certain agreements to resolve or settle a patent infringement claim in connection with the sale of a drug or biological product; permanently allows high deductible health plans to waive deductibles for insulin and associated products; and establishes the position of Chief Pharmaceutical Negotiator in the Office of the U.S. Trade Representative.
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (72)
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Health.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2023 · second_quarter · Health Issues
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 / HR 2620 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 19 "Lower Costs, More Cures Act of 2021," all provisions. Issues pertaining to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
Client expense: $1,090,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2023 · first_quarter · Health Issues
Issues pertaining to drug pricing and reimbursement, transparency and patient access. S 652 "Safe Step Act," all provisions. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act," all provisions relating to prescription drug pricing and taxes. HR 19 "Lower Costs, More Cures Act of 2021," all provisions. Issues pertaining to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 830 "HELP Ensure Copays Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.
Client expense: $1,460,000 · Firm income: Not reported
2023 · first_quarter · Pharmacy
Legislation regarding drug pricing, value, and reimbursement; H.R.3, Elijah Cummings Lower Drug Costs Now Act, and related Senate legislation; H.R.19, Lower Costs, More Cures Act of 2021; H.R.5376 - Build Back Better Act and Inflation Reduction Act - P.L. 117-169, issues related to drug policies and access to therapies for patients with rare diseases; H.R.1629, Fairness in Orphan Drug Exclusivity Act; H.R.7506, legislation to revolutionize education, diagnoses, and treatment of rare kidney diseases; H.R.7667, the Food and Drug Amendments of 2022 - provisions concerning accelerated approval, orphan drugs; S.4348, Food and Drug Administration Safety and Landmark Advancements Act of 2022 - provisions concerning accelerated approval, orphan drugs; H.R.6963, Accelerated Approval Integrity Act, a bill to amend the Federal Food, Drug, and Cosmetic Act to strengthen requirements for post-approval studies for drugs approved using accelerated approval, and for other purposes; H.R.2617, the Consolidated Appropriations Act, 2023.
Client expense: Not reported · Firm income: $60,000
2022 · third_quarter · Medicare/Medicaid
Medicare Advantage (MLR, risk adjustment, star ratings, supplemental benefits), Medicare Prior Authorization (H.R. 3173), Prescription Drug Rebates, Medicare Part D and Part D restructuring (H.R. 3, H.R. 19, S. 2164), Insulin Affordability (S. 3700, H.R. 6833), Telehealth, Build Back Better Act (H. Res. 601 & S. Con. Res. 14), Federal Coronavirus Response (American Rescue Plan, H.R. 1319), Parity for Audio-Only Risk Adjustment (H.R. 2166, S. 150), Inflation Reduction Act (P.L. 117-169), Third Party Marketing Organization Requirements, Behavioral Health (House Ways and Means Committee prints 117-1 & 117-2)
Client expense: $550,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Medicare/Medicaid
H.R. 4014, Physician Shortage GME Cap Flex Act of 2021, provisions relating to Graduate Medical Education S. 2094, Physician Shortage GME Cap Flex Act of 2021, provisions relating to Graduate Medical Education H.R. 1332, Telehealth Modernization Act, all provisions S. 368, Telehealth Modernization Act, all provisions H.R. 4058, Telemental Health Care Access Act of 2021, all provisions S. 2061, Telemental Health Care Access Act of 2021, all provisions H.R. 3173, Improving Seniors Timely Access to Care Act of 2021, provisions relating to Prior Authorization and attachment standards S. 3018, Improving Seniors Timely Access to Care Act of 2021, provisions relating to Prior Authorization and attachment standards H.R. 7995, Getting Over Lengthy Delays in Care As Required by Doctors (GOLD CARD) Act of 2022, all provisions H.R. 3259, Non-Opioids Prevent Addiction In the Nation (NO PAIN) Act, all provisions S. 586, Non-Opioids Prevent Addiction In the Nation (NO PAIN) Act, all provisions H.R. 4587, Value in Health Care Act of 2021, all provisions H.R. 7213, Equitable Community Access to Pharmacist Services Act, all provisions S. 748, Medicare Sequester Relief Act, all provisions H.R. 2903, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act, all provisions S. 1512, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act, all provisions H.R. 2256, Resident Physician Shortage Reduction Act, all provisions S. 834, Resident Physician Shortage Reduction Act, all provisions H.R. 1218, Data Mapping to Save Moms Lives Act, all provisions S. 198, Data Mapping to Save Moms Lives Act, all provisions H.R. 3407, Mothers and Offspring Mortality and Morbidity Awareness (MOMMAs) Act, all provisions S. 411, Mothers and Offspring Mortality and Morbidity Awareness (MOMMAs) Act, all provisions H.R. 3441, Substance Use Disorder Workforce Act, all provisions S. 1438, Opioid Workforce Act of 2021, all provisions H.R. 955, Medicaid Reentry Act of 2021, all provisions S. 285, Medicaid Reentry Act of 2021, all provisions H.R. 2654, Chiropractic Medicare Coverage Modernization Act of 2021, all provisions H.R. 6020, Supporting Medicare Providers Act of 2021, all provisions S. 3314, Supporting Medicare Providers Act of 2021, all provisions H.R. 6311, Comprehensive Addiction Resources Emergency Act of 2021, all provisions S. 3418, Comprehensive Addiction Resources Emergency Act of 2021, all provisions H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act, all provisions H.R. 19, Lower Costs, More Cures Act of 2021, all provisions S. 801, Connected Maternal Online Monitoring Act, all provisions H.R. 1738, Stabilize Medicaid and CHIP Coverage Act, all provisions H.R. 1025, Kids Access to Primary Care Act of 2021, all provisions H.R. 66, Comprehensive Access to Robust Insurance Now Guaranteed (CARING) for Kids Act, all provisions S. 610, Protecting Medicare and American Farmers from Sequester Cuts Act, all provisions H.R. 6000, Cures 2.0 Act, all provisions H.R. 4043, Ensuring Patient Access to Critical Breakthrough Products Act of 2021, all provisions S. 2416, New Opportunities for Value that Extend Lives (NOVEL) Act of 2021, all provisions H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022, all provisions H.R. 3746, Accountable Care in Rural America Act, all provisions H.R. 4755, Seniors Chronic Care Management Improvement Act of 2021, all provisions H.R. 6308, ACO Assignment Improvement Act of 2021, all provisions H.R. 1868, To prevent across-the-board direct spending cuts, and for other purposes, all provisions H.R. 315, Medicare Sequester COVID Moratorium Act, all provisions H.R. 6048, Medicare Stability for Patients and Providers Act, all provisions H.R. 3348, SOS: Sustaining Outpatient Services Act, all provisions H.R. 366, Protecting Access to Post-COVID-19 Telehealth Act of 2021, all provisions H.R. 2166, Ensuring Parity in MA and PACE for Audio-Only Telehealth Act of 2021, all provisions H.R. 2228, Rural Behavioral Health Access Act of 2021, all provisions H.R. 3447, Permanency for Audio-Only Telehealth Act, all provisions H.R. 7051, Access to Prescription Digital Therapeutics Act of 2022, all provisions S. 3791, Access to Prescription Digital Therapeutics Act of 2022, all provisions H.R. 7878, Kidney Health Connect Act of 2022, all provisions S. 4307, Kidney Health Connect Act of 2022, all provisions H.R. 6202, Telehealth Extension Act of 2021, all provisions S. 987, CARA 3.0 Act of 2021, all provisions H.R. 1438, Opioid Workforce Act of 2021, all provisions H.R. 925, Data to Save Moms Act, all provisions H.R. 7475, Mamas First Act, all provisions H.R. 3746, Accountable Care in Rural America Act, all provisions H.R. 4587, Value in Health Care Act of 2021, all provisions H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act, all provisions H.R. 3614, Menstrual Equity For All Act of 2021, provisions related to menstrual products coverage in Medicaid Medicare program: Physician Payment and Delivery Reform Medicare program: Impending Medicare payment cuts Medicare program: Medicare Evaluation and Management/budget neutrality Medicare program: Statutory PAYGO/Sequester Relief Medicare program: Accountable Care Organizations/specialty care Medicare program: Alternative Payment Models Medicare program: AMA Recovery Plan for Americas Physicians/payment reform Medicare program: Global and Professional Direct Contracting alternative payment model/REACH ACOs Medicare program: Appropriate Use Criteria and Prior Authorization Medicare program: Medicare Advantage/prior authorization regulation Medicare program: Automatic blood pressure measurement devices/coverage Medicare program: Merit-based Incentive Payment System (MIPS) Value Pathways (MVPs) Medicare program: MIPS/Promoting Interoperability/Cost/Improvement Activities Medicare program: MIPS/data sharing/transparency Medicare program: MACRA physician burdens Medicare program: Quality Payment Program Medicare program: Health IT burden Medicare program: Public Health Emergency COVID-19 /Accelerated and Advance Payments Medicare program: Primary Care First models Medicare program: Medicare Shared Savings Program (MSSP) Medicare program: Modifier 25 Medicare program: Split/shared billing Medicare program: Interoperability/data blocking/HIPAA Medicare program: Coding Medicare program: Provider compliance/Regulatory relief Medicare program: Provider Enrollment, Chain, and Ownership System (PECOS) Enrollment/Revalidation Medicare program: Open Payments Medicare program: Prescription drug pricing/Pharmacy Benefits Managers Medicare program: Step Therapy Medicare and Medicaid programs: Medicare Access and Chip Reauthorization Act (MACRA)/implementation Medicare and Medicaid programs: MACRA Oversight Medicaid program: Improving Access to Physical and Mental Health Care for Children and Youth Under Medicaid and CHIP draft Medicare and Medicaid programs: Health Equity Medicaid program: Maternal Mortality Medicaid program: Uninsured and healthcare coverage/COVID-19 Medicaid program: Special Enrollment Period Medicaid program: Sickle Cell Disease
| Republican |
| KY |
| Ann Wagner | Republican | MO |
| Ashley Hinson | Republican | IA |
| August Pfluger | Republican | TX |
| Austin Scott | Republican | GA |
| Barry Loudermilk | Republican | GA |
| Beth Van Duyne | Republican | TX |
| Billy Long | Republican | MO |
| Blaine Luetkemeyer | Republican | MO |
| Blake D. Moore | Republican | UT |
| Bob Gibbs | Republican | OH |
| Brad R. Wenstrup | Republican | OH |
| Brett Guthrie | Republican | KY |
| Bruce Westerman | Republican | AR |
| Bryan Steil | Republican | WI |
| Burgess Owens | Republican | UT |
| Carol D. Miller | Republican | WV |
| Chris Stewart | Republican | UT |
| Claudia Tenney | Republican | NY |
| Cliff Bentz | Republican | OR |
| Dan Crenshaw | Republican | TX |
| Daniel Meuser | Republican | PA |
| Daniel Webster | Republican | FL |
| Darin LaHood | Republican | IL |
| David B. McKinley | Republican | WV |
| David G. Valadao | Republican | CA |
| David Kustoff | Republican | TN |
| David P. Joyce | Republican | OH |
| David Schweikert | Republican | AZ |
| Debbie Lesko | Republican | AZ |
| Devin Nunes | Republican | CA |
| Diana Harshbarger | Republican | TN |
| Don Bacon | Republican | NE |
| Dusty Johnson | Republican | SD |
| Earl L. "Buddy" Carter | Republican | GA |
| Elise M. Stefanik | Republican | NY |
| Eric A. "Rick" Crawford | Republican | AR |
| Frank D. Lucas | Republican | OK |
| Fred Keller | Republican | PA |
| Glenn Grothman | Republican | WI |
| Glenn Thompson | Republican | PA |
| Greg Pence | Republican | IN |
| Gregory F. Murphy | Republican | NC |
| Gus M. Bilirakis | Republican | FL |
| Guy Reschenthaler | Republican | PA |
| H. Morgan Griffith | Republican | VA |
| Harold Rogers | Republican | KY |
| J. French Hill | Republican | AR |
| Jack Bergman | Republican | MI |
| Jackie Walorski | Republican | IN |
| Jaime Herrera Beutler | Republican | WA |
| Jake Ellzey | Republican | TX |
| Jake LaTurner | Republican | KS |
| James Comer | Republican | KY |
| James R. Baird | Republican | IN |
| Jason Smith | Republican | MO |
| Jay Obernolte | Republican | CA |
| Jeff Duncan | Republican | SC |
| Jerry L. Carl | Republican | AL |
| Jodey C. Arrington | Republican | TX |
| Joe Wilson | Republican | SC |
| John H. Rutherford | Republican | FL |
| John Joyce | Republican | PA |
| John R. Carter | Republican | TX |
| John R. Curtis | Republican | UT |
| John R. Moolenaar | Republican | MI |
| Kay Granger | Republican | TX |
| Kelly Armstrong | Republican | ND |
| Ken Calvert | Republican | CA |
| Kevin Brady | Republican | TX |
| Kevin Hern | Republican | OK |
| Kevin McCarthy | Republican | CA |
| Lance Gooden | Republican | TX |
| Larry Bucshon | Republican | IN |
| Lee M. Zeldin | Republican | NY |
| Liz Cheney | Republican | WY |
| Lloyd Smucker | Republican | PA |
| Madison Cawthorn | Republican | NC |
| Mariannette Miller-Meeks | Republican | IA |
| Mario Diaz-Balart | Republican | FL |
| Mark E. Green | Republican | TN |
| Mayra Flores | Republican | TX |
| Michael C. Burgess | Republican | TX |
| Michael Guest | Republican | MS |
| Michael K. Simpson | Republican | ID |
| Michael Waltz | Republican | FL |
| Michelle Steel | Republican | CA |
| Mike Bost | Republican | IL |
| Mike Carey | Republican | OH |
| Mike Garcia | Republican | CA |
| Mike Kelly | Republican | PA |
| Nancy Mace | Republican | SC |
| Neal P. Dunn | Republican | FL |
| Nicole Malliotakis | Republican | NY |
| Pat Fallon | Republican | TX |
| Pete Stauber | Republican | MN |
| Ralph Norman | Republican | SC |
| Randy Feenstra | Republican | IA |
| Richard Hudson | Republican | NC |
| Rick W. Allen | Republican | GA |
| Robert E. Latta | Republican | OH |
| Robert J. Wittman | Republican | VA |
| Rodney Davis | Republican | IL |
| Roger Williams | Republican | TX |
| Ron Estes | Republican | KS |
| Ronny Jackson | Republican | TX |
| Russ Fulcher | Republican | ID |
| Sam Graves | Republican | MO |
| Scott Franklin | Republican | FL |
| Stephanie I. Bice | Republican | OK |
| Steve Chabot | Republican | OH |
| Steve Scalise | Republican | LA |
| Steve Womack | Republican | AR |
| Steven M. Palazzo | Republican | MS |
| Ted Budd | Republican | NC |
| Thomas P. Tiffany | Republican | WI |
| Tim Burchett | Republican | TN |
| Tim Walberg | Republican | MI |
| Tom Cole | Republican | OK |
| Tom Reed | Republican | NY |
| Tom Rice | Republican | SC |
| Tony Gonzales | Republican | TX |
| Tracey Mann | Republican | KS |
| Troy Balderson | Republican | OH |
| Troy E. Nehls | Republican | TX |
| Vern Buchanan | Republican | FL |
| Vicky Hartzler | Republican | MO |
| Virginia Foxx | Republican | NC |
| W. Gregory Steube | Republican | FL |
| Young Kim | Republican | CA |
| HR 1873 |
117th |
| Related bill |
| HR 1857 | 117th | Related bill |
| HR 153 | 117th | Related bill |
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Client expense: $4,550,000 · 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), Office of Management & Budget (OMB), SENATE
2022 · third_quarter · Health Issues
H.R. 5376, Inflation Reduction Act (drug pricing provisions). S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act." Presidents FY23 Budget Request. H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. H.R. 7035, the Biologics Market Transparency Act." H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes. H.R. 1730, the Speeding Therapy Access Today Act of 2021. H.R. 2565, the FDA Modernization Act of 2021. H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021. H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act. H.R. 6963, the Accelerated Approval Integrity Act of 2022. H.R. 6973, the Enhanced Access to Affordable Medicines Act. H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act." H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. Proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and H.R. 3, the "Elijah E. Cummings Lower Drug Costs Now Act." H.R. 19, the "Lower Costs, More Cures Act of 2021." HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy). H.R. 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"). H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including H.R. 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements) and H.R. 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including H.R. 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), H.R. 2831, the "Prompt Approval of Safe Generic Drugs Act," H.R. 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). H.R. 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." H.R. 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). H.R. 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
Client expense: $830,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Pharmacy
Legislation regarding drug pricing, value, and reimbursement; H.R.3, Elijah Cummings Lower Drug Costs Now Act, and related Senate legislation; H.R.19, Lower Costs, More Cures Act of 2021; H.R.5376 - Build Back Better Act and Inflation Reduction Act - P.L. 117-169, issues related to drug policies and access to therapies for patients with rare diseases; H.R.1629, Fairness in Orphan Drug Exclusivity Act; H.R.7506, legislation to revolutionize education, diagnoses, and treatment of rare kidney diseases; H.R.7667, the Food and Drug Amendments of 2022 - provisions concerning accelerated approval, orphan drugs; S.4348, Food and Drug Administration Safety and Landmark Advancements Act of 2022 - provisions concerning accelerated approval, orphan drugs; H.R.6963, Accelerated Approval Integrity Act, a bill to amend the Federal Food, Drug, and Cosmetic Act to strengthen requirements for post-approval studies for drugs approved using accelerated approval, and for other purposes; H.R.2617, the Consolidated Appropriations Act, 2023.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Medicare/Medicaid
H.R. 3 Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 1946, S. 1873. Medicare Multi-Cancer Early Detection Screening Coverage; H.R. 2617-accelerated approval in the Omnibus year end H.R. 4065, S. 1971 (section 101), P.L. 117-328, H.R. 2617 Kidney disease screening, Expanding Medicare annual wellness benefit to include kidney disease screening. H.R. 5260 - Reduced Costs and Continued Cures Act; HR. 5376- Inflation Reduction Act; Build Back Better Act; CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure; Preventative healthcare services and screenings Issues related to preventative services and screenings for underrepresented communities IRA implementation, Pub. L. 117-169 Medicare Reform(s); Issues related to Medicare Part B and Part D pricing reform. General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; value-based payment arrangements; efforts to improve coding, coverage, and access for rare disease therapies; issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; general issues related to diagnostic reimbursement
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 · Health Issues
Draft, Hospital Competition Act of 2021 (no bill number) - procedural changes around The Mental Health Parity and Addiction Equity Act (MHPEA) litigation H.R. 19 - Lower Costs, More Cures Act of 2021- Rep. McMorris, Rodgers - prescription drug prices for Medicare and Medicaid H.R. 340 - Incentivizing Medicaid Expansion Act of 2021 - Rep. Veasey, Marc - Medicaid expansion H.R. 379 - Improving Social Determinants of Health Act of 2021 - Rep. Barragan, Nanette Diaz - Social Determinants of Health H.R. 432 - Mental Health Access Improvement Act of 2021- Rep. Thompson, Mike - mental health services under Medicare H.R. 778 - Secure Data and Privacy for Contact Tracing Act of 2021 - Rep. Speier, Jackie - digital contact tracing for COVID-19 H.R. 908 - MORE Health Education Act - Rep. Blunt Rochester, Lisa - federally facilitated exchanges H.R. 909 - Moms Matter Act - Rep. Blunt Rochester, Lisa - maternal mental health conditions and SUD H.R. 943 - Social Determinants for Moms Act - Rep. McBath, Lucy -SDOH and maternal health H.R. 959 - Black Maternal Health Momnibus Act of 2021 - Rep. Underwood, Lauren - maternal health including in Medicaid and CHIP H.R. 1212 - Kira Johnson Act - Rep. Adams, Alma - maternal health outcomes H.R. 1218 - Data Mapping to Save Moms Lives Act - Rep. Butterfield, G. K. -maternal health data H.R. 1268 - Building COVID-19 Vaccine Confidence Act of 2021 - Rep. Velazquez, Nydia - COVID-19 H.R. 1319 - American Rescue Plan Act of 2021 - Rep. Yarmuth, John - COVID-19 relief H.R. 1350 - Supporting Best Practices for Healthy Moms Act - Rep. Kelly, Robin - maternal health outcomes H.R. 1364 - Parity Enforcement Act of 2021 - Rep. Norcross, Donald - mental health and SUD H.R. 1400 - COVID-19 Health Disparities Action Act of 2021 - Rep. Cardenas, Tony -COVID-19 and health disparities H.R. 1406 - COVID-19 Emergency Telehealth Impact Reporting Act of 2021 - Rep. Curtis, John - telehealth and COVID-19 H.R. 1544 - Virtual Community Support Act of 2021 - Rep. Cardenas, Tony - mental health and SUD grants for community peer support H.R. 1647 - TREATS Act - Rep. McKinley, David - increase use of telehealth for SUD treatment H.R. 1721 - To amend the Consolidated Appropriations Act, 2021 to authorize additional funds for the Emergency Broadband Connectivity Fund, to provide grants to States and Tribal Entities to strengthen the National Lifeline Eligibility Verifier, to provide for Federal coordination between the National Lifeline Eligibility Verifier and the National Accuracy Clearinghouse - Rep. Veasey, Marc - Broadband H.R. 1835 - COVID Community Care Act - Rep. Lee, Barbara - COVID-19 response H.R. 1848 - LIFT America Act - Rep. Pallone, Frank, Jr. - broadband and public health infrastructure H.R. 1872 - MORE Health Education Act - Rep. Blunt Rochester, Lisa - Federal Exchange outreach and educational activities H.R. 1976 - Medicare for All Act of 2021 - Rep. Jayapal, Pramila - public option H.R. 1985 - Nursing Home Reform Modernization Act of 2021 - Rep. Pascrell, Bill, Jr. - quality and transparency H.R. 2010 - Public Option Deficit Reduction Act- Rep. DeFazio, Peter - public option H.R. 2163 - Safe Step Act - Rep. Ruiz, Raul - commercial plans and medication step-therapy requirements H.R. 2617 - Consolidated Appropriations Act, 2023 - Rep. Connolly, Gerald - continued Medicaid and Medicare provisions and funding for FY2023 H.R. 3173 - Improving Seniors Timely Access to Care Act of 2021 - Rep. DelBene, Suzan - prior authorization in Medicare Advantage H.R. 3753 - Parity Implementation Assistance Act - Rep. Cardenas, Tony - mental health parity H.R. 4040 - Advancing Telehealth Beyond COVID-19 Act of 2021- Rep. Cheney, Liz - telehealth H.R. 4595 - Medicaid Saves Lives Act - Rep. Bourdeaux, Carolyn - Medicaid expansion H.R. 6833 - Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - Rep. Craig, Angie - continued funding for Medicare and Medicaid H.R. 7236 - Strengthen Kids Mental Health Now Act of 2022 - Rep. Eshoo, Anna - mental health and Medicaid H.R. 7427 - To amend title XI of the Social Security Act to require CMI testing of incentive payments for behavioral health providers and certain other providers for adoption and use of certified electronic health record technology, and for other purposes. - Rep. Matsui, Doris - behavioral health and electronic health records H.R. 7512 - Protecting Patients from Deceptive Health Plans Act - Rep. Hayes, Jahana - excepted benefits coverage H.R. 7666 - Restoring Hope for Mental Health and Well-Being Act of 2022 - Rep. Pallone, Frank - reauthorization of several behavioral health programs H.R. 7667 - Food and Drug Amendments of 2022 - Rep. Eshoo, Anna - reauthorization of user fee programs H.R. 7780 - Mental Health Matters Act - Rep. DeSaulnier, Mark - changes to the procedure around MHPEA litigation H.R. 8152 - American Data Privacy and Protection Act - Rep. Pallone, Frank, Jr. - data privacy H.R. 8594 - Restore Protections for Dialysis Patients Act - Rep. Clarke, Yvette - reform of the Medicare Secondary Payer act H.R. 8876 - The Jackie Walorski Maternal and Child Home Visiting Reauthorization Act of 2022 - Rep. Davis, Danny - funding for maternal and early childhood health programs H.R. 8878 - To amend title XVIII of the Social Security Act to ensure adequate coverage of outpatient mental health services under the Medicare program. - Rep. Chu, Judy - mental health and Medicare H.R. 8879 - Inpatient Psychiatric Facility Improvement Act - Rep. Evans, Dwight - mental health and Medicare H.R. 8881 - To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to require group health plans and health insurance issuers offering group or individual health insurance coverage to disclose the percentage of in-network participation for certain provider types, and for other purposes. - Rep. Horsford, Steven - commercial plans H.R. 8884 - To direct the Secretary of Health and Human Services to provide outreach and reporting on opioid use disorder treatment services furnished by opioid treatment programs under the Medicare program. - Rep. Kelly Mike - mental health and Medicare H.R. 8885 - Better Health Care Directories Act - Rep. Kildee, Daniel - commercial plans H.R. 8886 - Promoting Clarity in Mental Health and Substance Use Disorder Treatment Act - Rep. Moore, Gwen - commercial plans H.R. 8889 - RICE Act - Rep. Plaskett, Stacey - commercial plans H.R. 8890 - Physician Wellness Program Act of 2022 - Rep. Ruiz, Raul - mental health and Medicare H.R. 8891 - No Surprises for Survivors Act of 2022 - Rep. Sanchez, Linda - requirements for group health plans and health insurance issuers offering group or individual health insurance coverage to provide coverage for forensic medical exams with no cost sharing H.R. 8892 - To direct the Secretary of Health and Human Services to conduct a public outreach campaign to inform individuals covered under a group health plan or group or individual health insurance coverage of Federal requirements relating to mental health and substance use disorder crisis services, and for other purposes. - Rep. Sewell, Terri - commercial plans H.R. 8908 - Fighting Stimulant and other Substance Use Disorders Act - Rep. Estes, Ron - mental health and Medicare H.R. 8910 - Behavioral Health Integration Awareness Act of 2022 - Rep. Smith, Jason - mental health and Medicare S. 24 - Protecting Personal Health Data Act - Sen. Klobuchar, Amy - privacy S. 104 - Improving Social Determinants of Health Act of 2021- Sen. Smith, Tina - health disparities S. 199 - Secure Data and Privacy for Contact Tracing Act of 2021 - Sen. Schatz, Brian - digital contact tracing for COVID-19 S. 201 - Improving Access to Health Care in Rural and Underserved Areas Act - Sen. Rosen, Jacky - rural health S. 334 - IMPACT to Save Moms Act - Sen. Casey, Robert - maternal health S. 340 - TREATS Act - Sen. Portman, Rob - telehealth, SUD and mental health S. 345 - Maternal Vaccinations Act - Sen. Kaine, Tim - maternal health S. 346 - Black Maternal Health Momnibus Act of 2021 - Sen. Booker, Cory - maternal health and health disparities S. 347 - Data to Save Moms Act - Sen. Smith, Tina - maternal health data S. 352 - Health Care Improvement Act of 2021 - Sen. Warner, Mark - health care costs and coverage S. 408 - Supporting Best Practices for Healthy Moms Act - Sen. Toomey, Pat - maternal health S. 411 - MOMMAs Act - Sen. Durbin, Richard - maternal health S. 464 - Safe Step Act - Sen. Murkowski, Lisa - commercial plans and medication step-therapy requirements S. 512 - Equitable Data Collection and Disclosure on COVID-19 Act of 2021- Sen. Warren, Elizabeth - COVID-19 Data Collection S. 586 - NOPAIN Act - Sen. Capito, Shelley Moore - non-opioid treatment S. 674 - Public Health Infrastructure Saves Lives Act- Sen. Murray, Patty - public health infrastructure S. 708 - Preventing Mental Health and Substance Use Crises During Emergencies Act - Sen. Kelly, Mark - mental health and SUD national strategy S. 745 - Accessible, Affordable Internet for All Act - Sen. Klobuchar, Amy - broadband S. 779 - Protecting Americans with Pre-Existing Conditions Act of 2021- Sen. Warner, Mark R. - state innovation waivers S. 782 - Nursing Home Reform Modernization Act of 2021- Sen. Casey, Robert P., Jr. - nursing home quality and transparency S. 783 - COVID Community Care Act - Sen. Warren, Elizabeth - COVID-19 response S. 851 - Social Determinants for Moms Act- Sen. Blumenthal, Richard - SDOH and maternal health S. 893 - Tech to Save Moms Act- Sen. Menendez, Robert - maternal health S. 983 - CHOICE Act - Sen. Whitehouse, Sheldon - public option S. 987 - TREATS Act - Sen. Portman, Rob - SUD prevention and treatment S. 1010 - Turn the Tide Act - Sen. Shaheen, Jeanne - Substance Use Disorder S. 1042 - Kira Johnson Act - Sen. Warnock, Raphael - maternal health S. 1512 - CONNECT for Health Act of 2021 - Sen. Schatz, Brian - expansion of telehealth for Medicare S. 1873 - Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021 - Sen. Crapo, Mike - Cancer screening in Medicare S. 1962 - Parity Implementation Assistance Act - Sen. Murphy, Christopher - mental health parity S. 2164 - Lower Costs, More Cures Act of 2021 - Sen. Crapo, Mike - prescription drug prices for Medicare and Medicaid S. 2315 - Medicaid Saves Lives Act - Sen. Warnock, Raphael - Medicaid expansion S. 2499 - SAFE DATA Act - Sen. Wicker, Roger - consumer data privacy and data transparency and security S. 3018 - Improving Seniors Timely Access to Care Act of 2021 - Sen. Marshall, Roger - prior authorization in Medicare Advantage S. 3195 - Consumer Online Privacy Rights Act - Sen. Cantwell, Maria - data privacy S. 3799 - Prevent Pandemics Act - Sen. Murray, Patty - pandemic preparedness S. 3983 - PATCH Act - Sen. Cassidy, Bill - data privacy S. 4264 - Advancing Integration in Medicare and Medicaid (AIM) Act - Sen. Scott, Tim - coordinating full-benefits for dual eligible individuals S. 4293 - Pharmacy Benefit Manager Transparency Act of 2022 - Sen. Cantwell, Maria and Sen. Grassley, Chuck - scope of PBM practices S. 4306 - Improving Access to Behavioral Health Integration Act - Sen. Smith, Tina - behavioral health S. 4750 - Restore Protections for Dialysis Patients Act - Sen. Menendez, Robert - reform of MSP Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10), identifiers, enforcement; cybersecurity; issues related to Medicare Secondary Payer requirements; issues related to health care price transparency; issues related to all payor claims databases; issues related to implementation of the National Health Information Infrastructure; electronic health records, personal health records, and similar technologies; issues relating to market consolidation; issues related to hospital and provider consolidation; issues related to medical management; issues relating to quality improvement; issues relating to the national health data stewardship; issues relating to hospital outpatient measurement and reporting; issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to the end of the public health emergency; issues related to health equity; issues related to vaccination; issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; prescription drug pricing; telehealth; issues related to the cost of insulin, including price, copays, rebates, and medical management tools; rural health; issues related to behavioral health benefits; issues related to Managed Long Term Services and Supports (MLTSS); issues related to the collection of race and ethnicity data; issues related to medical loss ratios; reference pricing; review of rates for reasonableness; preexisting condition insurance plans; issues relating to antitrust; issues relating to surprise medical bills; accountable care organizations; provider non-discrimination; coverage of preventive services; contraceptive coverage and reproductive health; pre-existing condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; issues related to health insurance tax; health plan automatic enrollment requirements; issues related to qualified health plans including certification and rate filing templates; health insurance market rules; ACA risk adjustment; dependent coverage; summary of benefits and coverage disclosures; benefit and payment parameters; essential health benefits, actuarial value, and accreditation; NQF reauthorization; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations; issues related to supplemental products; issues related to HIPAA excepted benefits; issues related to short term limited duration products; issues related to the federally-facilitated marketplaces (i.e., Exchanges/formerly referred to as the web portal); issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); issues related to association health plans; issues related to cost-sharing reductions (CSRs); issues related to the refundable credit for coverage under a qualified health plan and enhancements included in the American Rescue Plan Act (ARPA); issues related to Medicaid coverage gap; issues related to small employer group size; issues related to Certificate of Public Advantage; issues relating to veterans health care; issues relating to caregivers; and other issues relating to health care reform implementation.
Client expense: $2,470,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office
2022 · fourth_quarter · Pharmacy
Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, direct and indirect remuneration (DIR), pharmacy networks, and mail-service pharmacy Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2355: Opioid Prescription Verification Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524: Health Care PRICE Transparency Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act S.2164: Lower Costs More Cures Act H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.4293: Pharmacy Benefit Manager Transparency Act 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)
Client expense: $2,578,869 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2022 · fourth_quarter · Medicare/Medicaid
Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2855: Star Ratings for Biosimilars Act S.1523: The Drug Price Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs, More Cures Act of 2021 H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.2815: BIOSIM Act S.464 / H.R.2163: Safe Step Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.4418: SPIKE Act H.R.5237: A bill to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes. H.R.5260: Reduced Costs and Continued Cures Act H.R.3684: The Infrastructure Investment and Jobs Act, Sec.90006, Moratorium on implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Build Back Better Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Inflation Reduction Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5623: The Insulin Cost Reduction Act, To amend title XVIII of the Social Security Act to prohibit price concessions with respect to insulin drugs and exceptions under Part D of Medicare, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.6833: Affordable Insulin Now Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7995: GOLD CARD Act 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)
Client expense: $2,578,869 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2022 · fourth_quarter · Health Issues
Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: To amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes H.R.6833: Affordable Insulin Now Act H.R.6963: Accelerated Approval Integrity Act H.R.7008: Pre-approval Information Exchange Act H.R.7032: Increasing Transparency in Generic Drug Applications Act H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7666: Restoring Hope for Mental Health and Well-Being Act H.R.7667: Food and Drug Amendments of 2022 H.R.7828: To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years; (PRICED Act) S.4293: Pharmacy Benefit Manager Transparency Act S.4348: 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; (FDASLA Act) H.R.7995: GOLD CARD Act H.R.5376: The Inflation Reduction Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)
Client expense: $2,578,869 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2022 · fourth_quarter · Medicare/Medicaid
Issues related to Medicare Part D redesign, rebate reform and international pricing index (including H.R. 3, H.R. 19) Medicaid Drug Rebate Program (MDRP), including value-based purchasing (VBP) arrangements and line extensions Issues related to Biosimilars
Client expense: $810,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medicare/Medicaid
Executive Order on Lowering Prescription Drug Costs for Americans (October 4, 2022) H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs and drug pricing H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169); provisions related to drug pricing S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 4293: Pharmacy Benefit Manager Transparency Act of 2022 S. 2416: NOVEL Act of 2021 - Provisions related to novel medical products Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Pharmacy Benefit Manager reform and policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Notice of Benefit and Payment Parameters (NBPP)
Client expense: $860,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2022 · fourth_quarter · Medicare/Medicaid
Medicare payment issues including the Independent Payment Advisory Board (IPAB) and Medicaid issues. Medicare Part D. Drug pricing proposals including H.R. 3. Protecting Seniors Through Immunization Act. COVID-19 relief proposals. American Rescue Plan Act of 2021, P.L. 117-2, H.R. 1319. H.R.5376, "Inflation Reduction Act of 2022" (PL 117-169). H.R. 3. H.R. 19. Consolidated Appropriations Act, FY 23 (P.L. 117-328).
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
General education about policies impacting pharmaceutical development, approval and reimbursement; Drug safety and drug counterfeiting; Medicare Part D; Federal preemption for prescription drugs; drug importation; and drug shortages. Drug pricing proposals including H.R. 3. Medicare rebate reform, the 340B program, and proposals to impose "most favored nation" pricing on Medicare Part B and D. COVID-19 relief proposals. American Rescue Plan Act of 2021, P.L. 117-2, H.R. 1319. H.R.5376, "Inflation Reduction Act of 2022" (PL 117-169). H.R. 3. H.R. 19. HR 3927. S. 2082. Consolidated Appropriations Act, FY 23 (P.L. 117-328). PASTEUR Act H.R. 3932, S. 2076.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
General education about policies impacting pharmaceutical development, approval and reimbursement; Non-interference. Rebates for Medicare Part D. Importation. 340B Program. CMMI Medicare Part B Demonstration. Drug pricing legislation including H.R. 3, Medicare rebate reform, "buy America" proposals, and proposals to impose "most favored nation" pricing on Medicare Part B and D. Policies impacting U.S. address to the Covid-19 pandemic, including American Rescue Plan Act of 2021, P.L. 117-2, H.R. 1319. H.R.5376, "Inflation Reduction Act of 2022" (PL 117-169). H.R. 3. H.R. 19. H.R. 4511. Provisions included in the Consolidated Appropriations Act, FY 23 (P.L. 117-328) related to the regulation of pharmaceuticals.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medicare/Medicaid
General education about policies impacting pharmaceutical development, approval and reimbursement; Non-interference. Rebates for Medicare Part D. Importation. 340B Program. IPI drug pricing proposal, Medicare Rebate Rule. Drug pricing legislation including H.R. 3, Medicare rebate reform, "buy America" proposals, and proposals to impose "most favored nation" pricing on Medicare Part B and D. Policies impacting U.S. address to the Covid-19 pandemic, including American Rescue Plan Act of 2021, P.L. 117-2, H.R. 1319. H.R.5376, "Inflation Reduction Act of 2022" (PL 117-169). H.R. 3. H.R. 19. Provisions included in the Consolidated Appropriations Act, FY 23 (P.L. 117-328) related to the regulation of pharmaceuticals.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
General education about policies impacting pharmaceutical development, approval and reimbursement. H.R. 3, Lower Drug Costs Now Act; Policies impacting pharmaceutical research, development, and approval. Policies impacting public health preparedness and prevention and U.S. address to the Covid-19 pandemic, including the American Rescue Plan Act of 2021, P.L. 117-2, H.R. 1319. 340B Program. H.R.5376, "Inflation Reduction Act of 2022" (PL 117-169). H.R. 3. H.R. 19. Accelerated Approval pathway; Alzheimers diagnostics policies. Consolidated Appropriations Act, FY 23 (P.L. 117-328).
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medicare/Medicaid
Policies impacting Medicare Part D and Part B reimbursement policies. H.R. 3, Lower Drug Costs Now Act; Policies impacting pharmaceutical research, development, and approval. Policies impacting public health preparedness and prevention and U.S. address to the Covid-19 pandemic, including the American Rescue Plan Act of 2021, P.L. 117-2, H.R. 1319. H.R. 3. H.R. 19. H.R.5376, "Inflation Reduction Act of 2022" (PL 117-169). Consolidated Appropriations Act, FY 23 (P.L. 117-328).
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medicare/Medicaid
Executive Order on Lowering Prescription Drug Costs for Americans (October 4, 2022) CMS National Coverage Determination (NCD) covering Food and Drug Administration (FDA) approved monoclonal antibodies that target amyloid for the treatment of Alzheimers disease through coverage with evidence development (CED) H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5623: The Insulin Cost Reduction Act - Provisions related to prescription drug pricing and Medicaid H.R. 6833: Affordable Insulin Now Act S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2815: Seniors Saving on Insulin Act - Provisions related to Part D and insulin pricing S. 3700: Affordable Insulin Now Act S. 4293: Pharmacy Benefit Manager Transparency Act of 2022 S. 2416: NOVEL Act of 2021 - Provisions related to novel medical products Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Insulin policy issues Pharmacy Benefit Manager reform and policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Notice of Benefit and Payment Parameters (NBPP)
Client expense: $6,610,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Pharmacy
H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act and related Senate legislation. H.R. 19, Lower Costs More Cures Act. Legislative proposals regarding drug pricing, value, and reimbursement in H.R. 5376 Build Back Better Act/Inflation Reduction Act. H.R. 7667, the Food and Drug Amendments of 2022 and related Senate legislation. H.R.2471, Consolidated Appropriations Act, 2022 including the Food and Drug Omnibus Reform Act.
Client expense: $190,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medicare/Medicaid
H.R. 8800, Supporting Medicare Providers Act of 2022, all provisions H.R. 3434, Territories Health Equity Act of 2021, all provisions H.R. 4406, Supporting Medicaid in the U.S. Territories Act of 2021, all provisions H.R. 1332, Telehealth Modernization Act, all provisions S. 368, Telehealth Modernization Act, all provisions H.R. 2903, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2021, all provisions S. 1512, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2021, all provisions H.R. 366, Protecting Access to Post-COVID-19 Telehealth Act of 2021, all provisions H.R. 7051, Access to Prescription Digital Therapeutics Act of 2022, provisions relating to COVID-19 flexibilities, and telemental health S. 3791, Access to Prescription Digital Therapeutics Act of 2022, provisions relating to COVID-19 flexibilities, and telemental health S. 610, Protecting Medicare and American Farmers from Sequester Cuts Act, all provisions H.R. 4040, Advancing Telehealth Beyond COVID-19 Act of 2022, all provisions H.R. 2654, Chiropractic Medicare Coverage Modernization Act of 2021, all provisions H.R. 7213, Equitable Community Access to Pharmacist Services Act, all provisions H.R. 6087, Improving Access to Workers Compensation for Injured Federal Workers Act of 2022, all provisions H.R. 5067, Preserving Patient Access to Home Infusion Act, provisions relating to scope of practice S. 2652, Preserving Patient Access to Home Infusion Act, provisions relating to scope of practice H.R. 8812, Improving Care and Access to Nurses (I CAN) Act, all provisions S. 5212, Improving Care and Access to Nurses (I CAN) Act, all provisions H.R. 9577, Increasing Mental Health Options Act of 2022, all provisions S. 5272, Increasing Mental Health Options Act of 2022, all provisions H.R. 3173, Improving Seniors Timely Access to Care Act of 2021, all provisions S. 3018, Improving Seniors Timely Access to Care Act of 2021, all provisions H.R. 8487, Improving Seniors' Timely Access to Care Act of 2022, all provisions H.R. 3259, Non-Opioids Prevent Addiction In the Nation (NOPAIN) Act, all provisions S. 586, Non-Opioids Prevent Addiction In the Nation (NOPAIN) Act, all provisions H.R. 1438, Opioid Workforce Act of 2021, all provisions S. 1438, Opioid Workforce Act of 2021, all provisions H.R. 3441, Substance Use Disorder Workforce Act, all provisions H.R. 3407, Mothers and Offspring Mortality and Morbidity Awareness (MOMMAs) Act, provisions relating to Medicaid and CHIP, and maternal and infant mortality S. 411, Mothers and Offspring Mortality and Morbidity Awareness (MOMMAs) Act, provisions relating to Medicaid and CHIP, and maternal and infant mortality H.R. 925, Data to Save Moms Act, all provisions H.R. 959, Black Maternal Health Momnibus Act of 2021, all provisions S. 346, Black Maternal Health Momnibus Act of 2021, all provisions H.R. 3746, Accountable Care in Rural America Act, all provisions H.R. 4587, Value in Health Care Act of 2021, all provisions H.R. 4755, Seniors Chronic Care Management Improvement Act of 2021, all provisions H.R. 6308, ACO Assignment Improvement Act of 2021, all provisions S. 5249, Preserving Patient Access to Value-Based Care Act, all provisions H.R. 8879, Inpatient Psychiatric Facility Improvement Act, all provisions H.R. 8878, To amend title XVIII of the Social Security Act to ensure adequate coverage of outpatient mental health services under the Medicare program, all provisions H.R. 432, Mental Health Access Improvement Act of 2021, all provisions H.R. 8910, Behavioral Health Integration Awareness Act of 2022, all provisions H.R. 8884, Medicare Opioid Use Disorder Outreach Act, all provisions H.R. 8890, Physician Wellness Program Act of 2022, all provisions H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act, all provisions H.R. 19, Lower Costs, More Cures Act of 2021, all provisions H.R. 4058, Telemental Health Care Access Act of 2021, all provisions S. 2061, Telemental Health Care Access Act of 2021, all provisions S. 801, Connected Maternal Online Monitoring Act, all provisions H.R. 1738, Stabilize Medicaid and CHIP Coverage Act, all provisions H.R. 1025, Kids Access to Primary Care Act of 2021, all provisions H.R. 2256, Resident Physician Shortage Reduction Act of 2021, all provisions S. 834, Resident Physician Shortage Reduction Act of 2021, all provisions H.R. 7995, Getting Over Lengthy Delays in Care As Required by Doctors (GOLD CARD) Act of 2022, all provisions H.R. 955, Medicaid Reentry Act of 2021, all provisions S. 285, Medicaid Reentry Act of 2021, all provisions H.R. 4128, Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021, all provisions S. 2209, Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021, all provisions H.R. 6000, Cures 2.0 Act, all provisions H.R. 4043, Ensuring Patient Access to Critical Breakthrough Products Act of 2021, all provisions S. 2416, New Opportunities for Value that Extend Lives (NOVEL) Act of 2021, all provisions S. 2938, Bipartisan Safer Communities Act, all provisions H.R. 8594, Restore Protections for Dialysis Patients Act, all provisions S. 4750, Restore Protections for Dialysis Patients Act, all provisions H.R. 4014, Physician Shortage GME Cap Flex Act of 2021, all provisions S. 2094, Physician Shortage GME Cap Flex Act of 2021, all provisions H.R. 9378, Sunshine Act of 2022, all provisions H.R. 6576, Small Practice, Underserved, and Rural Support Program (SURS) Extension Act of 2022, all provisions Medicare program: Medicare and CHIP Reauthorization Act (MACRA) broad reform Medicare program: MACRA implementation Medicare program: MACRA burdens Medicare program: 21st Century Cures Act implementation Medicare program: Enhancing the Mental Health Workforce Medicare program: Improvement to Medicare Inpatient Psychiatric Facility Improvement Act Medicare program: Medicare program improvement/Physician Services and Education Medicare program: Accountable Care Organizations Medicare program: Medicare Economic Index (MEI)/inflation updates Medicare program: 2% Medicare sequester moratorium Medicare program: 4.5% payment rates reduction Medicare program: Medicare Physician Fee Schedule Conversion Factor/3% increase extension Medicare program: Global and Professional Direct Contracting alternative payment model/REACH ACOs Medicare program: Medicare physician payment Medicare program: Merit-based Incentive Payment Program (MIPS) improvement Medicare program: Alternative Payment Models (APMs) Medicare program: Medicare Physician Payment Reform/primary care/specialties Medicare program: Provider Enrollment, Chain, and Ownership System (PECOS)/Revalidation Medicare program: Recovery plan for Americas Physicians Medicare program: Physician-Owned Hospitals/Medicare Moratorium Medicare program: Health IT burdens Medicare program: EHR certification Medicare program: Provider Compliance/Regulatory Relief Medicare program: Quality Payment Program/physician burdens Medicare program: National provider directory Medicare program: Self-measured blood pressure (SMBP) devices/benefit category Medicare program: Information blocking Medicare program: Coding Medicare program: Skilled nursing facilities (SNF) Medicare and Medicaid programs: Cybersecurity Medicare and Medicaid programs: Puerto Rico/Medicaid caps/FMAP Medicaid program: Improving Access to Physical and Mental Health Care for Children and Youth Under Medicaid and CHIP Medicaid program: Ensuring Access to Telemental Health Services Medicaid program: Ensuring Access to Telemental Health Services Medicaid program: Enhancing the Mental Health Workforce Medicaid program: Improving Integration, Coordination, and Access to Care Medicaid program: Maternal mortality and morbidity/Equity
Client expense: $5,060,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), SENATE, White House Office
Discussions regarding drug pricing and supply chain issues, rare diseases, gene therapy and value based arrangements; biosimilar support; Alzheimer's policy, PET scan coverage and reimbursement, and dementia care H.R.19, Lower Costs, More Cures Act of 2021 H.R. 5376, Inflation Reduction Act, including provisions related to corporate taxes, Medicare, and prescription drug pricing H.R.7667, Food and Drug Amendments of 2022 User Fee Agreements, specifically reauthorization of PDUFA and BSUFA Aduhelm National Coverage Determination
Client expense: $900,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medicare/Medicaid
Issues related to Medicare Advantage and Part D prescription drug programs; Issues related to Prescription Drug Rebates; Issues related to Dual Eligible and Medicare Advantage Special Needs Plans; Issues related to Social Determinants of Health (SDOH)/Health Equity; and Issues related to Telehealth. 117th Congress Inflation Reduction Act of 2022 Budget Reconciliation/Biden Administration Build Back Better Plan COVID-19 American Rescue Plan American Jobs Plan Medicare Sequester COVID Moratorium Act (H.R. 315) Delay of the Prescription Drug Rebate Rule Ensuring Parity in MA for Audio-Only Telehealth Act of 2021 (S. 150) The Ensuring Parity in MA and PACE for Audio-Only Telehealth Act (HR 2166) Previous Congresses H.R. 3461, Community-Based Independence for Seniors Act H.R. 3877, Bipartisan Budget Act H.R. 19, Lower Costs, More Cures Act of 2019 S. 3013, Encouraging Innovative Benefit Design to Lower Costs for Seniors Act H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201, Families First Coronavirus Response Act H.R. 748, CARES Act H.R. 6800, HEROES Act H.R. 7659, Ensuring Parity in MA for Audio-Only Telehealth Act of 2020 S. 4318, American Workers, Families and Employers Assistance Act S. 4199, Prescription Drug Pricing Reduction Act of 2020 S.4840, Ensuring Parity in MA for Audio-Only Telehealth Act of 2020 Bipartisan Coronavirus Relief and Omnibus Funding Bill H.R. 4074, Addressing Social Determinants in Medicare Advantage PL 115-123: H.R. 1892, The bipartisan Budget Act of 2018; H.R. 3168, To amend title XVIII of the Social Security Act to provide continued access to specialized Medicare Advantage plans for special needs individuals, and for other purposes; S. 870, CHRONIC Care Bill PL 115-271: H.R. 6, SUPPORT for Patients and Communities Act
Client expense: $170,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Health Issues
- S. 464 / H.R. 2163 - Safe Step Act of 2021 - S. 779 Protecting Americans with Pre-Existing Conditions Act - H.R. 3 - H.R. 19 - S. 1681 the Advancing Education on Biosimilars Act - Out-of-pocket costs - H.R. 6000, Cures 2.0 Act - H.R. 5801, HELP Copays Act - Affordable Care Act - Pediatric Subspecialty Loan Repayment Program - Seniors Prescription Drug Relief Act - Build Back Better Act - Reconciliation - H.R. 7213, Equitable Community Access to Pharmacist Services Act - Health Equity - Healthcare Reform - Clinical Trial Diversity
Client expense: $75,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Medicare/Medicaid
Issues generally related to biopharmaceutical drugs and drug development programs, including but not limited to drug pricing proposals, Medicaid payments, access to treatment through telehealth, and access to rare disease and gene therapy drugs. Policies contained in drug pricing proposals, including H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act and H.R. 19/S.2164, Lower Costs, More Cures Act of 2021. Policies contained in 85 FR 87000, Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements. H.R. 7489, Medicaid VBPs for Patients Act or the MVP Act.
Client expense: Not reported · Firm income: $30,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Issues generally related to biopharmaceutical drugs and drug development programs, including, but not limited to: Orphan Drug Act incentives, including H.R. 1629/S.250, the Fairness in Orphan Drug Exclusivity Act; drug pricing proposals, including H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act and H.R. 19/S.2164, Lower Costs, More Cures Act of 2021; access to rare disease and gene therapy drugs; education and awareness of genetic rare bone disorders; FDA approvals of drugs designed to treat rare diseases, including gene therapies; and regulatory reforms generally, including but not limited to S. 3799, the PREVENT Pandemics Act, H.R. 6000, CURES 2.0, H.R. 6963, the Accelerated Approval Integrity Act of 2022, H.R. 6996, the Accelerating Access for Patients Act; H.R. 7667, Food and Drug Amendments of 2022, and S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act. Issues pertaining to newborn screening and gene panel screening, including provisions of H.R. 482/S.350 , the Newborn Screening Saves Lives Reauthorization Act of 2021. Policies contained in and amendments offered to S.Con.Res.5, setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030; and policies contained in and amendments offered to P.L. 117-2, the American Rescue Plan Act of 2021; P.L. 117-169, Inflation Reduction Act.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Health Issues
Consolidated Appropriations Act of 2023, H.R. 2617 (provisions related to pharmaceuticals and healthcare). H.R. 5376, Inflation Reduction Act (drug pricing provisions). S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act." Presidents FY23 Budget Request. H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. H.R. 7035, the Biologics Market Transparency Act." H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes. H.R. 1730, the Speeding Therapy Access Today Act of 2021. H.R. 2565, the FDA Modernization Act of 2021. H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021. H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act. H.R. 6963, the Accelerated Approval Integrity Act of 2022. H.R. 6973, the Enhanced Access to Affordable Medicines Act. H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act." H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. Proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and H.R. 3, the "Elijah E. Cummings Lower Drug Costs Now Act." H.R. 19, the "Lower Costs, More Cures Act of 2021." HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy). H.R. 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"). H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including H.R. 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements) and H.R. 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including H.R. 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), H.R. 2831, the "Prompt Approval of Safe Generic Drugs Act," H.R. 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). H.R. 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." H.R. 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). H.R. 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
Client expense: $480,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Health Issues
H.R. 6336 - Increasing Hospital Capacity to Fight the Coronavirus Act of 2021 S. 298 - Pharmacy Benefit Manage Accountability Study Act of 2021 H.R. 596 - ACCESS ACT H.R. 1829 - Pharmacy Benefit Manager Accountability Study Act of 2021. S. 4293 - Pharmacy Benefit Manager Transparency Act S. 155/H.R. 688 - Equal Access Care Act S. 153/H.R. 725 - Personalized Care Act of 2021 H.R. 2808 - Health Freedom and Flexibility Act H.R. 19 - Lower Costs, More Cures Act H.R.5376 - Build Back Better Act S. 4293 - Pharmacy Benefit Manager Transparency Act
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Proposed FDA guidance on gastroparesis clinical trials; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 - provisions related to data protection; Issues related to Dengue vaccines;
Client expense: $780,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medicare/Medicaid
HR 5376 Inflation Reduction Act of 2022. Provisions related to health care coverage, Medicare, Medicaid, COVID funding and mental/behavioral health HR 4128 VALID Act HR 8487 - Improving Seniors' Timely Access to Care Act of 2022 S 3792 & HR 7053 Hospital Inpatient Services Modernization Act HR 959 Black Maternal Health Omnibus Act of 2021 HR 4074 Addressing Social Determinants in Medicare Advantage Act of 2021 HR 4911 Medicare Advantage Quality Payment Relief Act HR 5370 Medically Tailored Home-Delivered Meals Demonstration Pilot Act of 2021 HR 5376 Build Back Better Act, to provide for Budget Reconciliation HR 3 Elijah E. Cummings Lower Drug Costs Now Act HR 19 and S. 2164 Lower Costs, More Cures Act of 2021 HR 3063 Maximizing Outcomes for Moms through Medicaid Improvement and Enhancement of Services (Mommies) Act HR 3172 Homes for Every Local Protector, Educator, and Responder (HELPER) Act of 2021 HR 2166 & S 150 Ensuring Parity in MA for Audio-Only Telehealth Act of 2021 S 833 Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 S 908 Medicare Drug Price Negotiation Act HR 2139 Medicare Drug Price Negotiation Act
Client expense: $180,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Medicare/Medicaid
HR3, Elijah E. Cummings Lower Drug Costs Now Act, all provisions. HR19 / S. 2164, Lower Costs, More Cures Act of 2021, all provisions. Legislation to incentivize new technology for innovation in home dialysis (no current bill number). S.2025/H.R.5331, Patient Access to ESRD New Innovative Devices Act, all provisions. Issues relating to innovation in ventilators.
Client expense: $470,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medicare/Medicaid
21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---S.2327: Seniors Prescription Drug Relief Act ---COVID-19 Pricing-Related Provisions ---Patient Cost-Sharing and Smoothing Data Privacy ---H.R.8152: American Data Privacy and Protection Act Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Step Therapy Vaccines and Infectious Diseases ---H.R.1978/S.912: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.4127: DISARM Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---National Coverage Determination
Client expense: $3,740,000 · 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 · Health Issues
21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2022 ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Healthcare Disparities ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver Climate Change ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---H.R.8152: American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight ---H.R.4128/S.2209: VALID Act Diversity & Inclusion ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---H.R.5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R.6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.6963: Accelerated Approval Integrity Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---H.R.6996: Accelerating Approval for Patients Act ---H.R.7008: The Pre-Approval Information Exchange Act ---S.1644: Promising Pathway Act ---S.1645: Accelerated Drug Approval for Prescription Therapies (ADAPT) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Reforms to the Accelerated Approval Pathway ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Drug Manufacturing, Quality & Distribution ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.6988: Drug Manufacturing Innovation Act ---H.R.7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies (INSPECTIONS) Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for FDA ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for National Institutes of Health ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---H.R.2617: Consolidated Appropriations Act of 2023 Generic Drug Entry ---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021 ---H.R.2883: Stop Stalling Access to Affordable Medications Act ---S.4351/H.R. 6973: Enhanced Access to Affordable Medicines Act ---S.4338/H.R. 7032: Increasing Transparency in Generic Drug Applications Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Incentives for Generic Entry Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.5566: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Rare Pediatric Disease Priority Review ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Step Therapy Vaccines and Infectious Diseases ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---S.4509 Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Vaccine Injury Compensation Program ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)
Client expense: $3,740,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
2022 · fourth_quarter · Medicare/Medicaid
Medicare Advantage (MLR, risk adjustment, star ratings, supplemental benefits), Medicare Prior Authorization (H.R. 3173), Prescription Drug Rebates, Medicare Part D and Part D restructuring (H.R. 3, H.R. 19, S. 2164), Insulin Affordability (S. 3700, H.R. 6833), Telehealth, Build Back Better Act (H. Res. 601 & S. Con. Res. 14), Federal Coronavirus Response (American Rescue Plan, H.R. 1319), Parity for Audio-Only Risk Adjustment (H.R. 2166, S. 150), Inflation Reduction Act (P.L. 117-169), Third Party Marketing Organization Requirements, Behavioral Health (House Ways and Means Committee prints 117-1 & 117-2), Consolidated Appropriations Act, 2023 (P.L. 117-403).
Client expense: $570,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Pharmacy
HR 3, Lower Drug Costs Now Act; HR 5260, Reduced Cost and Continued Care Act; Specialty Drugs and Prescription Drug Pricing, HR 19.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medicare/Medicaid
H.R. 3554 / S. 1909, the Pharmacy DIR Reform To Reduce Senior Drug Costs Act; H.R. 2608, the Ensuring Seniors Access to Local Pharmacies Act; H.R. 2759 / S. 1362, the Pharmacy and Medically Underserved Areas Enhancement Act; H.R. 3682, the Improving Transparency to Lower Drug Costs Act; H.R. 2484, the Lowest Price for Patients Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 / S. 2164, the Lower Costs, More Cures Act of 2021; H.R. 3173, the Improving Seniors Timely Access to Care Act of 2021; H.R. 4121, the PRO Seniors Act; Proposed inclusion of Medicaid managed care spread pricing prohibition to pay for H.R. 3684, the Infrastructure Investment and Jobs Act; H.R. 5237, the Reduced Costs and Continued Cures Act of 2021 H.R. 5376, the Build Back Better Act; H.R. 5804, the Expanding Access to Diabetes Self-Management Training Act of 2021; H.R. 6101, the Drug Price Transparency in Medicaid Act of 2021; Part B billing and COVID oral antivirals; S. 3700, the Affordable Insulin Now Act; H.R. 7213, Equitable Community Access to Pharmacist Services Act; CY 2023 Medicare Advantage and Part D Final Rule (CMS-4192-F); Draft legislation, the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act; H.R. 5376, the Inflation Reduction Act of 2022; Draft legislation on pharmacy DIR fee reform
Client expense: $320,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Small Business Administration (SBA), White House Office
2022 · third_quarter · Health Issues
H.R. 6336 - Increasing Hospital Capacity to Fight the Coronavirus Act of 2021 S. 298 - Pharmacy Benefit Manage Accountability Study Act of 2021 H.R. 596 - ACCESS ACT H.R. 1829 - Pharmacy Benefit Manager Accountability Study Act of 2021. S. 4293 - Pharmacy Benefit Manager Transparency Act S. 155/H.R. 688 - Equal Access Care Act S. 153/H.R. 725 - Personalized Care Act of 2021 H.R. 2808 - Health Freedom and Flexibility Act H.R. 19 - Lower Costs, More Cures Act H.R.5376 - Build Back Better Act S. 4293 - Pharmacy Benefit Manager Transparency Act
Client expense: Not reported · Firm income: $15,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Pharmacy
HR 3, Lower Drug Costs Now Act; HR 5260, Reduced Cost and Continued Care Act; Specialty Drugs and Prescription Drug Pricing, HR 19.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medicare/Medicaid
H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act. H.R. 19, S. 2164, Lower Costs, More Cures Act of 2021. H.R. 5376, Build Back Better Act, specifically issues dealing with Medicare.
Client expense: $40,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Discussions regarding drug pricing and supply chain issues, rare diseases, gene therapy and value based arrangements; biosimilar support; Alzheimer's policy, PET scan coverage and reimbursement, and dementia care H.R.19, Lower Costs, More Cures Act of 2021 H.R. 5376, Build Back Better Act, including provisions related to corporate taxes, Medicare, and prescription drug pricing CMS/NCD draft decision on monoclonal antibodies H.R.7667, Food and Drug Amendments of 2022 S.4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act User Fee Agreements, specifically reauthorization of PDUFA and BSUFA
Client expense: $940,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Medicare/Medicaid
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 - The Inflation Reduction Act of 2022; General issues related to patient access to rare disease therapies, Part B and Part D drugs; Issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; Value-based payment arrangements; Efforts to improve coding, coverage, and access for rare disease therapies; Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; General issues related to diagnostic reimbursement S. 1873/H.R. 1946 - Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021 Issues related to preventative services and screenings for underrepresented communities H.R 4065/S. 1971 (Section 101) - Expanding Medicare annual wellness benefit to include kidney disease screening CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure General issues related to diagnostic reimbursement
Client expense: $930,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
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 · Medicare/Medicaid
H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2327: Seniors Prescription Drug Relief Act - Provisions related to Part D, prescription drug access and pricing S. 4293: Pharmacy Benefit Manager Transparency Act of 2022 S. 2416: NOVEL Act of 2021 - Provisions related to novel medical products Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Notice of Benefit and Payment Parameters (NBPP) Provisions related to Medicare's noninterference clause
Client expense: $1,390,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2022 · third_quarter · Pharmacy
Legislation regarding drug pricing, value, and reimbursement; H.R. 3, Elijah Cummings Lower Drug Costs Now Act, and related Senate legislation; H.R. 19, Lower Costs, More Cures Act of 2021; H.R. 5376 - Build Back Better Act and Inflation Reduction Act - P.L. 117-169, issues related to drug policies and access to therapies for patients with rare diseases; H.R. 1629, Fairness in Orphan Drug Exclusivity Act; H.R. 7506, legislation to revolutionize education, diagnoses, and treatment of rare kidney diseases; H.R. 7667, the Food and Drug Amendments of 2022 - provisions concerning accelerated approval, orphan drugs; S. 4348, Food and Drug Administration Safety and Landmark Advancements Act of 2022 - provisions concerning accelerated approval, orphan drugs; H.R. 6963, Accelerated Approval Integrity Act, a bill to amend the Federal Food, Drug, and Cosmetic Act to strengthen requirements for post-approval studies for drugs approved using accelerated approval, and for other purposes.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · third_quarter · Health Issues
Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: To amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes H.R.6833: Affordable Insulin Now Act H.R.6963: Accelerated Approval Integrity Act H.R.7008: Pre-approval Information Exchange Act H.R.7032: Increasing Transparency in Generic Drug Applications Act H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7666: Restoring Hope for Mental Health and Well-Being Act H.R.7667: Food and Drug Amendments of 2022 H.R.7828: To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years; (PRICED Act) S.4293: Pharmacy Benefit Manager Transparency Act S.4348: 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; (FDASLA Act) H.R.7995: GOLD CARD Act H.R.5376: The Inflation Reduction Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)
Client expense: $1,908,258 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2022 · third_quarter · Pharmacy
Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, direct and indirect remuneration (DIR), pharmacy networks, and mail-service pharmacy Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2355: Opioid Prescription Verification Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524: Health Care PRICE Transparency Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act S.2164: Lower Costs More Cures Act H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.4293: Pharmacy Benefit Manager Transparency Act 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)
Client expense: $1,908,258 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2022 · third_quarter · Medicare/Medicaid
Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2855: Star Ratings for Biosimilars Act S.1523: The Drug Price Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs, More Cures Act of 2021 H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.2815: BIOSIM Act S.464 / H.R.2163: Safe Step Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.4418: SPIKE Act H.R.5237: A bill to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes. H.R.5260: Reduced Costs and Continued Cures Act H.R.3684: The Infrastructure Investment and Jobs Act, Sec.90006, Moratorium on implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Build Back Better Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Inflation Reduction Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5623: The Insulin Cost Reduction Act, To amend title XVIII of the Social Security Act to prohibit price concessions with respect to insulin drugs and exceptions under Part D of Medicare, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.6833: Affordable Insulin Now Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7995: GOLD CARD Act 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)
Client expense: $1,908,258 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
Discussions regarding drug pricing and supply chain issues, rare diseases, gene therapy and value based arrangements; biosimilar support; Alzheimer's policy, PET scan coverage and reimbursement, and dementia care H.R.19, Lower Costs, More Cures Act of 2021 H.R. 5376, Inflation Reduction Act (Build Back Better Act), including provisions related to corporate taxes, Medicare, and prescription drug pricing H.R.7667, Food and Drug Amendments of 2022 User Fee Agreements, specifically reauthorization of PDUFA and BSUFA Aduhelm National Coverage Determination
Client expense: $900,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE