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Ensuring Patient Access to Critical Breakthrough Products Act of 2021
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
43pct
1d open
vs 9,698 other HR bills in the 117th — cohort avg 63d
Ensuring Patient Access to Critical Breakthrough Products Act of 2021 This bill provides for Medicare coverage of medical devices that are approved under the Food and Drug Administration (FDA) Breakthrough Devices Program. (Under the program, manufacturers work with the FDA to expedite the review and approval of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions.) The bill allows designated medical breakthrough devices to be temporarily covered under Medicare during a four-year transitional period. The Centers for Medicare & Medicaid Services (CMS) must assign payment codes for such devices within three months of FDA approval. The CMS must also establish a process to allow for continued coverage after the transitional period has expired, taking into account any additional evidence or data the CMS deems necessary. The CMS must also provide for temporary and, where appropriate, permanent Medicare coverage of breakthrough devices for which there is no existing benefit category (i.e., classification).
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Filing registrants (15)
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Health.
Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, 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 · first_quarter · Medicare/Medicaid
Issues related to Protecting Access to Medicare Act Issues related to Medicare coverage reform Issues related to coverage of telehealth services Issues related to Medicare coverage for digital health technologies Issues related to Protecting Medicare and American Farmers from Sequesters Act (S.610) Issues related to physician fee schedule Issues related to H.R. 3173/S. 3018 Improving Seniors Timely Access to Care Issues related to H.R. 4043 Ensuring Patient Access to Critical Breakthrough Products Act Issues related to H.R. S. 4449/H.R. 8188 Saving Access to Laboratory Services Act
Client expense: $840,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2022 · fourth_quarter · Health Issues
H.R. 5376, the Inflation Reduction Act H.R. 6000, the CURES 2.0 Act H.R. 4043, the Ensuring Patient Access to Critical Breakthrough Products Act H.R.2617, Consolidated Appropriations Act, 2023 user fee reauthorization policies
Client expense: Not reported · Firm income: $80,000
2022 · third_quarter · Taxation/Internal Revenue Code
Health tax issues and trade, H.R.4043 - Ensuring Patient Access to Critical Breakthrough Products Act of 2021
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Medical/Disease Research/Clinical Labs
Health tax issues and trade, H.R.4043 - Ensuring Patient Access to Critical Breakthrough Products Act of 2021 Issues related to Small Business Innovation Research Program Medical Device User Fee Amendments IV
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medicare/Medicaid
H.R. 4043 Ensuring Patient Access to Critical Breakthrough Products Act. H.R. 8188 Saving Access to Laboratory Services Act. Proposals related to Medicare coverage of continuous glucose monitors. Proposals to ensure Medicare coverage for emerging medical device technology. Proposals related to medical device reimbursement and coverage.
Client expense: $1,300,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
| Democratic |
| PA |
| Carol D. Miller | Republican | WV |
| Chris Pappas | Democratic | NH |
| Chrissy Houlahan | Democratic | PA |
| Conor Lamb | Democratic | PA |
| Dan Crenshaw | Republican | TX |
| David B. McKinley | Republican | WV |
| Fred Upton | Republican | MI |
| Gus M. Bilirakis | Republican | FL |
| J. Luis Correa | Democratic | CA |
| Jackie Walorski | Republican | IN |
| Jake Auchincloss | Democratic | MA |
| James P. McGovern | Democratic | MA |
| Jason Smith | Republican | MO |
| John Joyce | Republican | PA |
| Kim Schrier | Democratic | WA |
| Liz Cheney | Republican | WY |
| Lloyd Smucker | Republican | PA |
| Madeleine Dean | Democratic | PA |
| Michelle Steel | Republican | CA |
| Mike Kelly | Republican | PA |
| Neal P. Dunn | Republican | FL |
| Pete Aguilar | Democratic | CA |
| Scott H. Peters | Democratic | CA |
| Susan Wild | Democratic | PA |
| Ted Lieu | Democratic | CA |
| Terri A. Sewell | Democratic | AL |
| Thomas R. Suozzi | Democratic | NY |
| Tom Emmer | Republican | MN |
| Tony Cárdenas | Democratic | CA |
Government targets: 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
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 · fourth_quarter · Medicare/Medicaid
General Medicare / Medicaid Issues. H.R.4043 - Ensuring Patient Access to Critical Breakthrough Products Act of 2021.
Client expense: $120,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medicare/Medicaid
General Medicare / Medicaid Issues. H.R.4043 - Ensuring Patient Access to Critical Breakthrough Products Act of 2021.
Client expense: $120,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medicare/Medicaid
H.R. 4043 Ensuring Patient Access to Critical Breakthrough Products Act. H.R. 8188 Saving Access to Laboratory Services Act. Proposals related to Medicare coverage of continuous glucose monitors. Proposals to ensure Medicare coverage for emerging medical device technology. Proposals related to medical device reimbursement and coverage.
Client expense: $1,220,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Drug pricing issues; CMS reimbursement including Medicare coverage of innovative technology; Ensuring Patient Access to Critical Breakthrough Products Act H.R.4043; Inflation Reduction Act (HR 5376) Public Law No. 117-169.; Cures 2.0 Act H.R.6000; Proposals for Advanced Research Project Agency- Health: ARPA-H Act, H.R.5585.
Client expense: $790,191 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2022 · fourth_quarter · Medicare/Medicaid
Issues related to opioid-induced respiratory compromise continuous patient monitoring, including H.R. 5932 - Inpatient Opioid Safety Act of 2021 Issues related to Medicare coverage and payment for breakthrough medical devices, including H.R.4043 - Ensuring Patient Access to Critical Breakthrough Products Act Issues related to Medicare coverage of digital health technologies Issues related to payment rates under 2023 Medicare Physician Fee Schedule proposed rule Issues related to Medicare PAYGO sequester relief
Client expense: $730,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medicare/Medicaid
Issues related to Protecting Access to Medicare Act Issues related to Medicare coverage reform Issues related to coverage of telehealth services Issues related to Medicare coverage for digital health technologies Issues related to Protecting Medicare and American Farmers from Sequesters Act (S.610) Issues related to physician fee schedule Issues related to H.R. 3173/S. 3018 Improving Seniors Timely Access to Care Issues related to H.R. 4043 Ensuring Patient Access to Critical Breakthrough Products Act Issues related to H.R. S. 4449/H.R. 8188 Saving Access to Laboratory Services Act
Client expense: $750,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2022 · fourth_quarter · Health Issues
H.R. 5376, the Inflation Reduction Act H.R. 6000, the CURES 2.0 Act H.R. 4043, the Ensuring Patient Access to Critical Breakthrough Products Act H.R.2617, Consolidated Appropriations Act, 2023 user fee reauthorization policies
Client expense: Not reported · Firm income: $80,000
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
2022 · fourth_quarter · Health Issues
FDA approval paths. Health care reform. Drug pricing policy. Reimbursement policy. H.R. 4043 - Ensuring Patient Access to Critical Breakthrough Products Act. Proposals for Advanced Research Project Agency-Health; H.R. 5585 - ARPA-H Act. H.R. 6000 - Cures 2.0 Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
Health tax issues and trade, H.R.4043 - Ensuring Patient Access to Critical Breakthrough Products Act of 2021 Issues related to Small Business Innovation Research Program Medical Device User Fee Amendments IV
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Taxation/Internal Revenue Code
Health tax issues and trade, H.R.4043 - Ensuring Patient Access to Critical Breakthrough Products Act of 2021
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medicare/Medicaid
Issues related to Medicare coverage of health technologies and services; Medicare Coverage for Innovative Technology Rule; H.R.4043, Ensuring Patient Access to Critical Breakthrough Products Act of 2021; MDUFA Reauthorization; H.R.7667, Food and Drug Amendments of 2022, S.4348, FDASLA Act of 2022; H.R.2617, Consolidated Appropriations Act, 2023.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Medicare Program Medicare Reimbursement: Transitional Coverage of Emerging Technologies; Medicare coverage of breakthrough technologies (HR 4043); coverage with evidence development (CED); inclusion of UDI in claims forms; physician reimbursement: clinical labor update; graduate medical education Use of real world data and real world evidence FDA Reform COVID-19 FDA reporting requirements under Public Health Emergency (CARES Act) COVID-19 CARES Act funding for rural hospitals; expanded use of telehealth Medical device supply chain Medical device shortage reporting Domestic production of medical products FDA Emerging Postmarket Medical Device Signals Communication PREVENT Act Medical Device User Fees (FDA Omnibus Reform Act) and FDA Reform bills: FDASLA and FDA Amendments of 2022 Predetermined Change Protocols Program
Client expense: $140,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Medicare/Medicaid
CMS Coverage Policies For Medical Devices Implementation of PL 114-255, 21st Century Cures Act CMS Payment Policies for Medical Devices Ensuring Patient Access to Critical Breakthrough Products (H.R.4043) (includes MCIT Proposed Rule) Heart Valve Disease Awareness Coronavirus Preparedness and Response Provisions (PHE) Health Equity Issues Coverage with Evidence Development H.R. 6, SUPPORT For Patients and Communities Act (Sunshine) H.R.2617 - Consolidated Appropriations Act, 2023
Client expense: $350,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · third_quarter · Medicare/Medicaid
H.R. 1332, Telehealth Modernization Act, all provisions S. 368, Telehealth Modernization Act, all provisions H.R. 3259, Non-Opioids Prevent Addiction In the Nation (NOPAIN) Act, all provisions S. 586, NOPAIN 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, CONNECT for Health 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. 3407, Mothers and Offspring Mortality and Morbidity Awareness (MOMMAs) Act, all provisions S. 411, MOMMAs Act, 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. 4058, Telemental Health Care Access Act of 2021, all provisions S. 2061, Telemental Health Care Access Act of 2021, all provisions H.R. 3441, Substance Use Disorder Workforce Act, all provisions S. 1438, Substance Use Disorder Workforce Act, 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, provisions related to scope of practice H.R. 6020, Supporting Medicare Providers Act of 2021, all provisions S. 3314, Supporting Medicare Providers Act of 2021, all provisions H.R. 4587, Value in Health Care Act of 2021, all provisions S. 2938, Bipartisan Safer Communities Act, all provisions H.R. 8800, Supporting Medicare Providers Act of 2022, all provisions H.R. 4040, Advancing Telehealth Beyond COVID-19 Act of 2022, all provisions H.R. 8850, Fair Access In Residency (FAIR) Act, all provisions S. 2173, Promoting Responsible and Effective Virtual Experiences through Novel Technology to Deliver Improved Access and Better Engagement with Tested and Evidence-based Strategies (PREVENT DIABETES) Act, all provisions S. 4873, Improving Access to Advance Care Planning 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. 7213, Equitable Community Access to Pharmacist Services 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. 8188, Saving Access to Laboratory Services Act (SALSA), all provisions S. 4449, SALSA Act, 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. 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 S. 610, Protecting Medicare and American Farmers from Sequester Cuts Act, all provisions H.R. 6048, Medicare Stability for Patients and Providers Act, 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 S. 801, Connected Maternal Online Monitoring Act, all provisions S. 346, Black Maternal Health Momnibus Act of 2021, 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. 748, Medicare Sequester Relief 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. 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. 7573, Telehealth Extension and Evaluation Act, all provisions S. 3593, Telehealth Extension and Evaluation Act, 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 H.R. 7053, Hospital Inpatient Services Modernization Act, all provisions S. 3792, Hospital Inpatient Services Modernization Act, all provisions H.R. 7116, 9-8-8 Implementation Act of 2022, 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, 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, all provisions S. 987, CARA 3.0 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. 5067, Preserving Patient Access to Home Infusion Act, all provisions S. 2652, Preserving Patient Access to Home Infusion Act, all provisions H.R. 8812, To amend titles XVIII and XIX of the Social Security Act and the Bipartisan Budget Act of 2018 to increase access to services provided by advanced practice registered nurses under the Medicare and Medicaid programs, and for other purposes, provisions related to scope of practice Medicare program: 21st Century Cures Act/implementation Medicare program: EHR Certification Medicare program: Medicare and CHIP Reauthorization Act (MACRA) Reform Medicare program: MACRA implementation Medicare program: Laboratory testing/Diagnostics/PAMA Medicare program: Merit-based Incentive Payment System (MIPS) quality/cost/improvement activities/promoting interoperability Medicare program: Merit-based Value Pathway Medicare program: Physician Fee Schedule (PFS) inflation updates/budget neutrality rules Medicare program: 2023 Medicare Physician Fee Schedule/4.5% cut Medicare program: Accountable specialty care/payments Medicare program: Alternative Payment Models/incentive payments Medicare program: Telehealth/COVID flexibilities Medicare program: Health IT burdens Medicare program: Self-measured blood pressure devices/benefit category Medicare program: Coding Medicare program: Primary Care First models Medicare program: Appropriate Use Criteria Medicare program: Opioids Medicare program: Medicare Shared Savings Program (MSSP) Medicare program: Dental benefits Medicaid program: Uninsured and healthcare coverage/COVID-19 Medicare program: Provider Enrollment, Chain, and Ownership System (PECOS)/revalidation Medicare program: Open Payments Medicaid program: Special Enrollment Period Medicaid program: Sickle Cell Disease Medicaid program: Improving Access to Physical and Mental Health Care for Children and Youth Under Medicaid and CHIP/draft Medicare program: Provider compliance and regulatory relief Medicare program: Medicare Administrative Contractors (MACs)/Downcoding Medicare and Medicaid programs: Health Equity Medicare and Medicaid programs: Modifier 25, Impossible Day Medicare and Medicaid programs: Connected health technologies Medicare and Medicaid programs: Diabetes
Client expense: $4,360,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · third_quarter · Health Issues
FDA approval paths. Health care reform. Drug pricing policy. Reimbursement policy. H.R. 4043 - Ensuring Patient Access to Critical Breakthrough Products Act. Proposals for Advanced Research Project Agency-Health; H.R. 5585 - ARPA-H Act. H.R. 6000 - Cures 2.0 Act. Inflation Reduction Act (H.R. 5376) Public Law No. 117-169.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
H.R. 5376, the Inflation Reduction Act H.R. 6000, the CURES 2.0 Act H.R. 4043, the Ensuring Patient Access to Critical Breakthrough Products Act user fee reauthorization
Client expense: Not reported · Firm income: $80,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Medicare/Medicaid
Issues related to opioid-induced respiratory compromise continuous patient monitoring, including H.R. 5932 - Inpatient Opioid Safety Act of 2021 Issues related to Medicare coverage and payment for breakthrough medical devices, including H.R.4043 - Ensuring Patient Access to Critical Breakthrough Products Act Issues related to non-opioid pain therapies, including S.586, the NOPAIN Act Issues related to Medicare coverage of digital health technologies Issues related to Medicare insulin copay caps and Inflation Reduction Act (H.R. 5376) Issues related to Medicare Advantage prior authorization Issues related to payment rates under Medicare Physician Fee Schedule proposed rule
Client expense: $1,463,550 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Medical/Disease Research/Clinical Labs
Health tax issues and trade, H.R.4043 - Ensuring Patient Access to Critical Breakthrough Products Act of 2021 Issues related to Small Business Innovation Research Program Medical Device User Fee Amendments IV
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Taxation/Internal Revenue Code
Health tax issues and trade, H.R.4043 - Ensuring Patient Access to Critical Breakthrough Products Act of 2021
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Medicare/Medicaid
CMS Coverage Policies For Medical Devices Implementation of PL 114-255, 21st Century Cures Act CMS Payment Policies for Medical Devices Ensuring Patient Access to Critical Breakthrough Products (H.R.4043) (includes MCIT Proposed Rule) Heart Valve Disease Awareness Coronavirus Preparedness and Response Provisions (PHE) Health Equity Issues Coverage with Evidence Development HR 5394 Registry Access to Medicare Claims Data includes Coverage with Evidence Development provisions H.R. 6, SUPPORT For Patients and Communities Act (Sunshine)
Client expense: $310,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · third_quarter · Health Issues
Drug pricing issues; CMS reimbursement including Medicare coverage of innovative technology; Ensuring Patient Access to Critical Breakthrough Products Act H.R.4043; Inflation Reduction Act (HR 5376) Public Law No. 117-169.; Cures 2.0 Act H.R.6000; Proposals for Advanced Research Project Agency- Health: ARPA-H Act, H.R.5585.
Client expense: $607,142 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2022 · third_quarter · Medicare/Medicaid
Issues related to Medicare coverage of health technologies and services; Medicare Coverage for Innovative Technology Rule; H.R.4043, Ensuring Patient Access to Critical Breakthrough Products Act of 2021; MDUFA Reauthorization; H.R.7667, Food and Drug Amendments of 2022, S.4348, FDASLA Act of 2022; H.R.6833, Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180).
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
Drug pricing issues; CMS reimbursement including Medicare coverage of innovative technology; Ensuring Patient Access to Critical Breakthrough Products Act H.R.4043; Inflation Reduction Act (HR 5376) Public Law No. 117-169.; Cures 2.0 Act H.R.6000; Proposals for Advanced Research Project Agency- Health: ARPA-H Act, H.R.5585.
Client expense: $857,235 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2022 · third_quarter · Medicare/Medicaid
General Medicare / Medicaid Issues. H.R.4043 - Ensuring Patient Access to Critical Breakthrough Products Act of 2021.
Client expense: $120,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE, White House Office
2022 · third_quarter · Health Issues
Medicare Program Medicare Reimbursement: Transitional Coverage of Emerging Technologies; Medicare coverage of breakthrough technologies (HR 4043); coverage with evidence development (CED); inclusion of UDI in claims forms; physician reimbursement: clinical labor update; graduate medical education Use of real world data and real world evidence FDA Reform COVID-19 FDA reporting requirements under Public Health Emergency (CARES Act) COVID-19 CARES Act funding for rural hospitals; expanded use of telehealth Medical device supply chain Medical device shortage reporting Domestic production of medical products FDA Emerging Postmarket Medical Device Signals Communication PREVENT Act Medical Device User Fees and FDA Reform bills: FDASLA and FDA Amendments of 2022 Predetermined Change Protocols Program
Client expense: $140,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · second_quarter · Medicare/Medicaid
General Medicare / Medicaid Issues. H.R.4043 - Ensuring Patient Access to Critical Breakthrough Products Act of 2021.
Client expense: $120,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE
2022 · second_quarter · Health Issues
Medicare Program Medicare Reimbursement: Transitional Coverage of Emerging Technologies; Medicare Coverage of Innovative Technology pathway; Medicare coverage of breakthrough technologies (HR 4043); coverage with evidence development (CED); inclusion of UDI in claims forms; physician reimbursement: clinical labor update; graduate medical education Use of real world data and real world evidence FDA Reform COVID-19 FDA reporting requirements under Public Health Emergency (CARES Act) COVID-19 CARES Act funding for rural hospitals; expanded use of telehealth Medical device supply chain Medical device shortage reporting Domestic production of medical products FDA Emerging Postmarket Medical Device Signals Communication PREVENT Act Medical Device User Fees and FDA Reform bills: FDASLA and FDA Amendments of 2022
Client expense: $150,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · second_quarter · Medicare/Medicaid
CMS Coverage Policies For Medical Devices Implementation of PL 114-255, 21st Century Cures Act CMS Payment Policies for Medical Devices Ensuring Patient Access to Critical Breakthrough Products (H.R.4043) (includes MCIT Proposed Rule) Heart Valve Disease Awareness Coronavirus Preparedness and Response Provisions (PHE) Health Equity Issues Coverage with Evidence Development HR 5394 Registry Access to Medicare Claims Data includes Coverage with Evidence Development provisions H.R. 6, SUPPORT For Patients and Communities Act (Sunshine)
Client expense: $330,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · second_quarter · Medicare/Medicaid
Issues related to opioid-induced respiratory compromise continuous patient monitoring, including H.R. 5932 - Inpatient Opioid Safety Act of 2021 Issues related to Medicare coverage and payment for Breakthrough-designated medical devices, including H.R.4043 - Ensuring Patient Access to Critical Breakthrough Products Act Issues related to non-opioid pain therapies, including S.586, the NOPAIN Act Issues related to Medicare coverage of digital health technologies
Client expense: $666,100 · Firm income: Not reported
Government targets: 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
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 · second_quarter · Health Issues
Drug pricing issues; CMS reimbursement including Medicare coverage of innovative technology; Ensuring Patient Access to Critical Breakthrough Products Act H.R.4043; the Build Back Better Act, a bill to provide for reconciliation pursuant to title II of the Concurrent Resolution on the Budget for Fiscal Year 2022, S. Con. Res. 14.; Cures 2.0 Act H.R.6000; Proposals for Advanced Research Project Agency- Health: ARPA-H Act, H.R.5585.
Client expense: $857,235 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2022 · second_quarter · Health Issues
H.R. 5376, the Build Back Better Act H.R. 6000, the CURES 2.0 Act H.R. 4043, the Ensuring Patient Access to Critical Breakthrough Products Act user fee reauthorization
Client expense: Not reported · Firm income: $80,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Medicare/Medicaid
Issues related to Medicare coverage of health technologies and services; Medicare Coverage for Innovative Technology Rule; H.R.4043, Ensuring Patient Access to Critical Breakthrough Products Act of 2021; MDUFA Reauthorization, H.R.7667, Food and Drug Amendments of 2022, S.4348, FDASLA Act of 2022.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Health Issues
FDA approval paths. Health care reform. Drug pricing policy. Reimbursement policy. H.R. 4043 - Ensuring Patient Access to Critical Breakthrough Products Act. Proposals for Advanced Research Project Agency-Health; H.R. 5585 - ARPA-H Act. H.R. 6000 - Cures 2.0 Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Taxation/Internal Revenue Code
Health tax issues and trade, H.R.4043 - Ensuring Patient Access to Critical Breakthrough Products Act of 2021
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Medical/Disease Research/Clinical Labs
Health tax issues and trade, H.R.4043 - Ensuring Patient Access to Critical Breakthrough Products Act of 2021 Issues related to Small Business Innovation Research Program Medical Device User Fee Amendments IV
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · first_quarter · Medicare/Medicaid
Issues related to Medicare policies on continuous glucose monitors and closed loop systems. Issues related to opioid-induced respiratory compromise continuous patient monitoring, including H.R. 5932 - Inpatient Opioid Safety Act of 2021. Issues pertaining to FY22 Inpatient Rule and LITT DRG reassignment. Issue related to Medicare coverage and payment for Breakthrough-designated medical devices, including H.R.4043 - Ensuring Patient Access to Critical Breakthrough Products Act. Issues related to telemedicine and remote patient monitoring, including H.R.4670 - Advanced Safe Testing at Residence Telehealth Act of 2021. Issues related to non-opioid pain therapies. Issues related to Medicare coverage of digital health technologies. Issues pertaining to Medicare provider payment cuts.
Client expense: $870,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · first_quarter · Health Issues
Drug pricing issues; CMS reimbursement including Medicare coverage of innovative technology; Ensuring Patient Access to Critical Breakthrough Products Act H.R.4043; the Build Back Better Act, a bill to provide for reconciliation pursuant to title II of the Concurrent Resolution on the Budget for Fiscal Year 2022, S. Con. Res. 14.; Cures 2.0 Act H.R.6000; Proposals for Advanced Research Project Agency- Health: ARPA-H Act, H.R.5585.
Client expense: $575,312 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2022 · first_quarter · Medicare/Medicaid
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. 6020, Supporting Medicare Providers Act of 2021, all provisions S. 3314, Supporting Medicare Providers Act of 2021, all provisions S. 610, Protecting Medicare and American Farmers from Sequester Cuts Act, all provisions H.R. 6048, Medicare Stability for Patients and Providers Act, 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. 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. 3441, Substance Use Disorder Workforce Act, all provisions S. 1438, Opioid Workforce 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. 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 S. 346, Black Maternal Health Momnibus Act of 2021, 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. 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 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. 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 S. 748, Medicare Sequester Relief Act, all provisions H.R. 2163, Safe Step Act, all provisions S. 464, Safe Step Act, 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. 4587, Value in Health Care 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 H.R. 6311, Comprehensive Addiction Resources Emergency (CARE) Act of 2021, all provisions S. 3418, Comprehensive Addiction Resources Emergency (CARE) Act of 2021, 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. 6202, Telehealth Extension Act of 2021, all provisions S. 3593, Telehealth Extension and Evaluation Act, all provisions H.R. 2807, Promoting Responsible and Effective Virtual Experiences through Novel Technology to Deliver Improved Access and Better Engagement with Tested and Evidence-based Strategies (PREVENT DIABETES) Act, all provisions S. 2173, Promoting Responsible and Effective Virtual Experiences through Novel Technology to Deliver Improved Access and Better Engagement with Tested and Evidence-based Strategies (PREVENT DIABETES) Act, all provisions H.R. 5804, Expanding Access to Diabetes Self-Management Training Act of 2021, all provisions S. 2203, Expanding Access to Diabetes Self-Management Training Act of 2021, all provisions S. 596, Treat and Reduce Obesity 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. 366, Protecting Access to Post-COVID-19 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. 2503, Social Determinants Accelerator Act of 2021, all provisions S. 3039, Social Determinants Accelerator Act of 2021, all provisions H.R. 987, CARA 3.0 Act of 2021, all provisions H.R. 925, Data to Save Moms Act, 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. 6583, Stop the Wait Act of 2022, all provisions S. 224, Stop the Wait Act of 2022, all provisions H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act, all provisions H.R. 7213, Equitable Community Access to Pharmacist Services Act, all provisions Medicare program: Gold Card Act/draft Medicare program: 21st Century Cures Act Medicare program: Protecting Access to Medicare Act (PAMA)/Laboratory testing/diagnostics Medicare program: Small Practice, Underserved, and Rural Support Program (SURS) Extension Act of 2022 Medicare program: Telehealth and dialysis centers/COVID-19 flexibilities continuation Medicare program: Telehealth/telephone visit codes/equity/quality Medicare program: Physician Payment Reform Medicare program: MEDPAC Report Medicare program: 2% Medicare sequester moratorium/continuation Medicare program: 4% Medicare sequester/Statutory PAYGO Medicare program: Physician payment/inflation index Medicare program: Medicare Physician Fee Schedule Conversion Factor/extension of 3% increase Medicare program: Medicare Diabetes Prevention Program (MDPP) model Medicare program: Global and Professional Direct Contracting Model (GPDC)/Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH) Medicare program: Evaluation and Management (E/M)/budget neutrality Medicare program: Prior authorization Medicare program: Interoperability Medicare program: EFT fees Medicare program: Merit-based Incentive Payment System (MIPS)/Quality/Cost/Improvement activities Medicare program: MIPS Value Pathways (MVPs) Medicare program: MIPS draft cost measures/field testing extension Medicare program: Value-based care acceleration/transparency/stability Medicare program: Virtual credit cards Medicare program: Primary Care First models Medicare program: Medicare Shared Savings Program (MSSP) Medicare program: RVS Update Committee (RUC)/Current Procedural Terminology (CPT) Medicare program: Split/shared billing Medicare program: PECOS Enrollment/Revalidation Medicare program: Open Payments Medicare program: Step Therapy Medicare program: Public health emergency/accelerated and advance payments Medicare program: MACRA oversight Medicare program: MACRA/physician burdens Medicare program: Alternative payment models (APMs) Medicare and Medicaid programs: Medicare Access and CHIP Reauthorization Act (MACRA)/implementation/Accountable Care Organizations Medicare and Medicaid programs: Information blocking/Patient privacy Medicare and Medicaid programs: COVID-19 response Medicare and Medicaid programs: Mental Health Parity and Addiction Equity Act (MHPAEA)/patient protection Medicare and Medicaid programs: Health equity/COVID-19 Medicare and Medicaid programs: Drug overdose epidemic Medicare and Medicaid programs: Health IT burdens Medicaid program: Medicaid funding in US territories Medicaid program: Uninsured individuals/COVID-19 Medicaid program: Special enrollment period Medicaid program: Sickle Cell Disease
Client expense: $6,520,000 · 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), Medicare Payment Advisory Commission (MedPAC), Office of Natl Drug Control Policy (NDCP), SENATE
2022 · first_quarter · Medicare/Medicaid
CMS Coverage Policies For Medical Devices Implementation of PL 114-255, 21st Century Cures Act CMS Payment Policies for Medical Devices Ensuring Patient Access to Critical Breakthrough Products (H.R.4043) (includes MCIT Proposed Rule) Heart Valve Disease Awareness Transcatheter Mitral Valve National Coverage Decision Coronavirus Preparedness and Response Provisions Health Equity Issues Coverage with Evidence Development HR 5394 Registry Access to Medicare Claims Data includes Coverage with Evidence Development provisions H.R. 6, SUPPORT For Patients and Communities Act (Sunshine)
Client expense: $260,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · first_quarter · Medicare/Medicaid
General Medicare / Medicaid Issues. H.R.4043 - Ensuring Patient Access to Critical Breakthrough Products Act of 2021.
Client expense: $110,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · first_quarter · Medicare/Medicaid
Issues related to Medicare coverage of health technologies and services; Medicare Coverage for Innovative Technology Rule; H.R.4043, Ensuring Patient Access to Critical Breakthrough Products Act of 2021; MDUFA Reauthorization.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · first_quarter · Taxation/Internal Revenue Code
Health tax issues and trade, H.R.4043 - Ensuring Patient Access to Critical Breakthrough Products Act of 2021
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE