Biosimilars Competition Act of 2018
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
49pct
4d open
vs 7,393 other HR bills in the 115th — cohort avg 50d
Biosimilars Competition Act of 2018 This bill amends the Public Health Service Act to require a biologic manufacturer and a biosimilar drug manufacturer to provide notification to the Department of Justice and the Federal Trade Commission regarding certain pharmaceutical agreements. The agreements requiring notice are those related to the manufacturer, marketing or sale of the biosimilar product or the reference product. Biosimilars are biological products approved by the Food and Drug Administration based on their similarity to an already-approved biological product.
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Filing registrants (12)
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2019 · first_quarter · Health Issues
Affordable Healthcare Act (ACA)Regulations; ACA Stabilization; American Health Care Act (AHCA); Health Care Reform; Reinsurance; Health Savings Accounts; Repeal and Replace; Grace Periods; SEPs; Medicare Cost plan; Marketplace Stability; Individual Marketplace Reform; Better Care Reconciliation Act (BCRA), mental health, transparency, HSA HR 633 Patient Fairness and Relief Act of 2017 Introduced by Greg Harper (R-MS) To authorize health indurance issuers to continue to offer for sale health insurance coverage in the individual market before the enactment of the minimum EHB. HR 708 State Age Rating Flexibility Act of 2017 Introduced by Larry Buschon (R-IN) This bill amends the Public Health Service Act to increase the permissible variation based on age for health insurance premiums for coverage offered in the individual or small group market from a factor of three to five, or to be determined by the state. HR 2212 CREATES Act of 2017 HR 6478 Biosimilars Competition Act of 2018 HR 2554 Patient Right to Know Drug Price Act HR 4666 Premium Relief Act of 2017 S 1352 Individual Health Insurance Marketplace Improvement HR 3976 Access to Marketplace Insurance Act Poioid epidemic: CREATS Act, Drug Pricing; PBM/Prescription Drug Costs Rx Rebates; Direct-to-consumer advertising
Client expense: $32,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Pharmacy
S. 297, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug costs S. 974, CREATES Act (Leahy-Grassley) - access to generic drugs and biosimilars S. 1115, Making Pharmaceutical Markets More Competitive Act (Collins-McCaskill) - accelerated approval of generic therapies S. 1131, FAIR Drug Pricing Act (Baldwin-McCain) - transparency in prescription drug pricing S. 2553, Know the Lowest Price Act (Stabenow) - pharmacist-patient communications S. 2554, Patient Right to Know Drug Prices Act (Collins) - pharmacist-patient communications, reporting of biosimilar pay-for-delay settlements S. 3194, Capping Prescription Costs Act (Warren) - capping prescription copays S. 3738, Hatch-Waxman Integrity Act (Hatch) - inter partes review process S. 3792, Preserve Access to Affordable Generics and Biosimilars Act (Klobuchar-Grassley) - pay-for-delay settlements H.R. 749, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug costs H.R. 1703, Medical Product Communication Act (Griffith) - off-label exchange of information H.R. 2026, Pharmaceutical Information Exchange Act (Guthrie) - pre-approval health care economic information to payors H.R. 2051, Fair Access for Safe and Timely Generics Act (McKinley-Welch) - access to generic drugs H.R. 2212, CREATES Act (Marino-Cicilline) - access to generic drugs and biosimilars H.R. 2439, FAIR Drug Pricing Act (Schakowsky) - transparency in prescription drug pricing H.R. 2562, Making Pharmaceutical Markets More Competitive Act (Kelly) - accelerated approval of generic therapies H.R. 2999, Patients' Access to Treatments Act (McKinley) - limiting cost sharing in specialty drug tiers H.R. 5247, Right to Try Act (Fitzpatrick) - use of unapproved investigational drugs by patients with life-threatening conditions H.R. 6142, Reducing Drug Waste Act (Doggett) - packaging of medications H.R. 6157, Defense-Labor-HHS-Education Appropriations Act (Granger) -pharmaceutical price transparency in DTC advertising H.R. 6340, Capping Prescription Costs Act (Rosen) - capping prescription copays H.R. 6478, Biosimilars Competition Act (Sarbanes) - reporting of pay-for-delay settlements H.R. 6576, Drug-Price Transparency in Communications Act (Schakowsky) - disclosure of drug prices in DTC advertising H.R. 6733, Know the Cost Act (Carter) - pharmacist-patient communications H.R. 7251, Hatch-Waxman Integrity Act (Flores) - inter partes review process Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.
2018 · fourth_quarter · Health Issues
Preserve Access to Affordable Generics Act (S. 124); Regulatory exclusivity; Improving Access To Affordable Prescription Drugs Act (S. 771/H.R. 1776); Drug pricing; SUPPORT for Patients and Communities Act (H.R. 6); Biosimilars Competition Act of 2018 (H.R. 6478); Patient Right to Know Drug Prices Act (S. 2554/H.R. 6143); Medicare Negotiation and Competitive Licensing Act of 2018 (H.R. 6505); Making Objective Drug Evidence Revisions for New (MODERN) Labeling Act (S. 3519); citizen petitions; Medicare Part B international reference pricing; Hatch-Waxman Integrity Act of 2018 (S. 3738/H.R. 7251); Affordable Drug Manufacturing Act of 2018 (H.R. 7348/S. 3775); Preserve Access to Affordable Generics and Biosimilars Act (S. 3792); Direct-to-consumer pharmaceutical advertising.
Client expense: Not reported · Firm income: $320,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2018 · fourth_quarter · Medicare/Medicaid
Medicare Advantage; Medicare Prior Authorization; Medicaid Rebates; Medicaid Expansion; Medicaid General; CHIP Reform; Medicare Access & CHIP Reauthorization Act of 2015 (MACRA); Rate Notice and Call Letter; Medicare Part D; Medicaid Alignment; NBPP, Part D Donut Hole, Rx Rebates, Patient's Act (Dialysis), ACE Kid's Act; Medicare Data Sharing HR 6 SUPPORT for Patients and Communities Act Introduced June 13, 2018 by Greg Walden (R-OR) includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 3325 ACE Kids Act Introduced July 20, 2017 by Joe Barton (R-TX) To amend title XIX of the Social Security Act to provide States with the option of providing coordinated care for children with complex medical conditions through a health home, and for other purposes. HR 4143 Dialysis Patients Demonstration Act of 2017 Introduced October 26, 2017 by Jason Smith (R-MO) To establish a demonstration program to provide integrated care for Medicare beneficiaries with end-stage renal disease, and for other purposes. HR 6478 Biosimilars Competition Act of 2018 Introduced July 23, 2018 by John Sarbanes (D-MD) To enhance competition for prescription drugs by increasing the ability of the Department of Justice and Federal Trade Commission to enforce existing antitrust laws regarding biologic and biosimilar products, and for other purposes. S 2554 Patient Right to Know Drug Price Act of 2018 Introduced March 14, 2018 by Susan Collins (R-ME) Americans overspend by an estimated $135 million on prescriptions through their insurance, in cases when they would cost less out of pocket. Yet pharmacists are often under gag orders from telling customers about that discrepancy. A new bill introduced in the Senate would end this practice.
2018 · fourth_quarter · Pharmacy
S. 297, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug costs S. 974, CREATES Act (Leahy-Grassley) - access to generic drugs and biosimilars S. 1115, Making Pharmaceutical Markets More Competitive Act (Collins-McCaskill) - accelerated approval of generic therapies S. 1131, FAIR Drug Pricing Act (Baldwin-McCain) - transparency in prescription drug pricing S. 2553, Know the Lowest Price Act (Stabenow) - pharmacist-patient communications S. 2554, Patient Right to Know Drug Prices Act (Collins) - pharmacist-patient communications, reporting of biosimilar pay-for-delay settlements S. 3194, Capping Prescription Costs Act (Warren) - capping prescription copays S. 3738, Hatch-Waxman Integrity Act (Hatch) - inter partes review process S. 3792, Preserve Access to Affordable Generics and Biosimilars Act (Klobuchar-Grassley) - pay-for-delay settlements H.R. 749, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug costs H.R. 1703, Medical Product Communication Act (Griffith) - off-label exchange of information H.R. 2026, Pharmaceutical Information Exchange Act (Guthrie) - pre-approval health care economic information to payors H.R. 2051, Fair Access for Safe and Timely Generics Act (McKinley-Welch) - access to generic drugs H.R. 2212, CREATES Act (Marino-Cicilline) - access to generic drugs and biosimilars H.R. 2439, FAIR Drug Pricing Act (Schakowsky) - transparency in prescription drug pricing H.R. 2562, Making Pharmaceutical Markets More Competitive Act (Kelly) - accelerated approval of generic therapies H.R. 2999, Patients' Access to Treatments Act (McKinley) - limiting cost sharing in specialty drug tiers H.R. 5247, Right to Try Act (Fitzpatrick) - use of unapproved investigational drugs by patients with life-threatening conditions H.R. 6142, Reducing Drug Waste Act (Doggett) - packaging of medications H.R. 6157, Defense-Labor-HHS-Education Appropriations Act (Granger) -pharmaceutical price transparency in DTC advertising H.R. 6340, Capping Prescription Costs Act (Rosen) - capping prescription copays H.R. 6478, Biosimilars Competition Act (Sarbanes) - reporting of pay-for-delay settlements H.R. 6576, Drug-Price Transparency in Communications Act (Schakowsky) - disclosure of drug prices in DTC advertising H.R. 6733, Know the Cost Act (Carter) - pharmacist-patient communications H.R. 7251, Hatch-Waxman Integrity Act (Flores) - inter partes review process Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.
Client expense: $1,550,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office
Client expense: $1,590,000 · 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), Office of Personnel Management (OPM), Office of the Vice President of the United States, SENATE, Vice President of the U.S., White House Office
Client expense: $1,540,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office
2018 · fourth_quarter · Health Issues
Affordable Healthcare Act (ACA)Regulations; ACA Stabilization; American Health Care Act (AHCA); Health Care Reform; Reinsurance; Health Savings Accounts; Repeal and Replace; Grace Periods; SEPs; Medicare Cost plan; Marketplace Stability; Individual Marketplace Reform; Better Care Reconciliation Act (BCRA), mental health, transparency, HSA HR 633 Patient Fairness and Relief Act of 2017 Introduced by Greg Harper (R-MS) To authorize health indurance issuers to continue to offer for sale health insurance coverage in the individual market before the enactment of the minimum EHB. HR 708 State Age Rating Flexibility Act of 2017 Introduced by Larry Buschon (R-IN) This bill amends the Public Health Service Act to increase the permissible variation based on age for health insurance premiums for coverage offered in the individual or small group market from a factor of three to five, or to be determined by the state. HR 2212 CREATES Act of 2017 HR 6478 Biosimilars Competition Act of 2018 HR 2554 Patient Right to Know Drug Price Act HR 4666 Premium Relief Act of 2017 S 1352 Individual Health Insurance Marketplace Improvement HR 3976 Access to Marketplace Insurance Act Poioid epidemic: CREATS Act, Drug Pricing; PBM/Prescription Drug Costs Rx Rebates; Direct-to-consumer advertising
Client expense: $36,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Medicare/Medicaid
Medicare Advantage; Medicare Prior Authorization; Medicaid Rebates; Medicaid Expansion; Medicaid General; CHIP Reform; Medicare Access & CHIP Reauthorization Act of 2015 (MACRA); Medicare Part D; Medicaid Alignment; Part D Donut Hole, Rx Rebates, Patients Act (Dialysis), ACE Kids Act. HR 6 SUPPORT for Patients and Communities Act Introduced June 13, 2018 by Greg Walden (R-OR) includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 3325 ACE Kids Act Introduced July 20, 2017 by Joe Barton (R-TX) To amend title XIX of the Social Security Act to provide States with the options of providing coordinated care for children with complex medical conditions through a health home, and for other purposes. HR 4143 Dialysis Patients Demonstration Act of 2017 Introduced October 26, 2017 by Jason Smith (R-MO) To establish a demonstration program to provide integrated care for Medicare beneficiaries with end-stage renal disease, and for other purposes. HR 6478 Biosimilars Competition Act of 2018 Introduced July 23, 2018 by John Sarbanes (D-MD) To enhance competition for prescription drugs by increasing the ability of the Department of Justice and Federal Trade Commission to enforce existing antitrust laws regarding biologic and biosimilar products, and for other purposes. S 2554 Patient Right to Know Drug Price Act of 2018 Introduced March 14, 2018 by Susan Collins (R-ME) Americans overspend by an estimated $135 million on prescriptions through their insurance, in cases when they would cost less out of pocket. Yet pharmacists are often under gag orders from telling customers about that discrepancy. A new bill introduced in the Senate would end this practice.
Client expense: $40,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Medicare/Medicaid
Medicare Advantage; Medicare Prior Authorization; Medicaid Expansion; Medicaid General; CHIP Reform; Medicare Access & CHIP Reauthorization Act of 2015 (MACRA); Rate Notice and Call Letter; Medicare Part D; NBPP, Part D Donut Hole, Rx Rebates, Patient's Act (Dialysis) HR 6 SUPPORT for Patients and Communities Act Introduced June 13, 2018 by Greg Walden (R-OR) includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 4143 Dialysis Patients Demonstration Act of 2017 Introduced October 26, 2017 by Jason Smith (R-MO) To establish a demonstration program to provide integrated care for Medicare beneficiaries with end-stage renal disease, and for other purposes. HR 6478 Biosimilars Competition Act of 2018 Introduced July 23, 2018 by John Sarbanes (D-MD) To enhance competition for prescription drugs by increasing the ability of the Department of Justice and Federal Trade Commission to enforce existing antitrust laws regarding biologic and biosimilar products, and for other purposes. S 2554 Patient Right to Know Drug Price Act of 2018 Introduced March 14, 2018 by Susan Collins (R-ME) Americans overspend by an estimated $135 million on prescriptions through their insurance, in cases when they would cost less out of pocket. Yet pharmacists are often under gag orders from telling customers about that discrepancy. A new bill introduced in the Senate would end this practice.
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Medicare/Medicaid
Medicare Advantage; Medicare Prior Authorization; Medicaid Rebates; Medicaid Expansion; CHIP Reform; Medicare Access & CHIP Reauthorization Act of 2015 (MACRA); Rate Notice and Call Letter; Medicare Part D; Patient's Act (Dialysis); Part D Donut Hole; Prescription Drug Rebates; ACE Kid's Act HR 6 Introduced June 13, 2018 by Greg Walden (R-OR). The SUPPORT for Patients and Communities Act includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 3325 Introduced July 20, 2017 by Joe Barton (R-TX). This bill amends title XIX of the Social Security Act to provide states with the option of providing coordinated care for children with complex medical conditions through a health home, and for other purposes. HR 4143 Introduced October 26, 2017 by Jason Smith (R-MO). The Dialysis Patients Demonstration Act of 2017 establishes a demonstration program to provide integrated care for Medicare beneficiaries with end-stage renal disease, and for other purposes. HR 6478 Introduced July 23, 2018 by John Sarbanes (D-MD). The Biosimilars Competition Act of 2018 enhances competition for prescription drugs by increasing the ability of the Department of Justice and Federal Trade Commission to enforce existing antitrust laws regarding biologic and biosimilar products, and for other purposes. S 2554 Introduced March 14, 2018 by Susan Collins (R-ME). The Patient Right to Know Drug Price Act of 2018. Americans overspend by an estimated $135 million on prescriptions through their insurance, in cases where their drugs would cost less out of pocket. Yet pharmacists are often under gag orders from telling customers about that discrepancy. This bill would end this practice.
Client expense: $5,500 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · fourth_quarter · Medicare/Medicaid
Medicare Advantage; Medicare Prior Authorization; Medicaid Rebates; Medicaid Expansion; CHIP Reform; Medicare Access & CHIP Reauthorization Act of 2015 (MACRA); Rate Notice and Call Letter; Medicare Part D; Patient's Act (Dialysis); Part D Donut Hole; Prescription Drug Rebates; ACE Kid's Act HR 6 Introduced June 13, 2018 by Greg Walden (R-OR). The SUPPORT for Patients and Communities Act includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 3325 Introduced July 20, 2017 by Joe Barton (R-TX). This bill amends title XIX of the Social Security Act to provide states with the option of providing coordinated care for children with complex medical conditions through a health home, and for other purposes. HR 4143 Introduced October 26, 2017 by Jason Smith (R-MO). The Dialysis Patients Demonstration Act of 2017 establishes a demonstration program to provide integrated care for Medicare beneficiaries with end-stage renal disease, and for other purposes. HR 6478 Introduced July 23, 2018 by John Sarbanes (D-MD). The Biosimilars Competition Act of 2018 enhances competition for prescription drugs by increasing the ability of the Department of Justice and Federal Trade Commission to enforce existing antitrust laws regarding biologic and biosimilar products, and for other purposes. S 2554 Introduced March 14, 2018 by Susan Collins (R-ME). The Patient Right to Know Drug Price Act of 2018. Americans overspend by an estimated $135 million on prescriptions through their insurance, in cases where their drugs would cost less out of pocket. Yet pharmacists are often under gag orders from telling customers about that discrepancy. This bill would end this practice.
Client expense: $250,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, White House Office
2018 · fourth_quarter · Health Issues
FAST Genetics Act of 2017 (H.R. 2051) CREATES Act of 2017 (H.R. 2212/S. 974) Preserve Access to Affordable Generics Act (S. 124) 340B PAUSE ACT (H.R. 4710) Legislation to place a moratorium on the 340B drug payment cuts in the CY 2018 Outpatient Prospective Payment System Rule (H.R. 4392) Protecting Jessica Grubbs Legacy Act (S. 1850) Overdose Prevention and Patient Safety Act (H.R. 3545, 5795, 6082) ACA Medicaid disproportionate share hospital (DSH) cuts Childrens Health Insurance Program (CHIP) funding ACO Improvement Act of 2017 (H.R. 4580) Medicare Home Infusion Therapy Access Act of 2017 (S. 1738)/ Section 101 of Medicare Part B Improvement Act of 2017 (H.R. 3178) Prescription Drug Price Transparency Act (MAC bill) (H.R.1316) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R.1038/S.413) Ensuring Seniors Access to Local Pharmacies Act of 2017 (H.R.1939/S.1044) Pharmacy and Medically Underserved Areas Enhancement Act (H.R.592/S.109) CARA 2.0 Act of 2018 (H.R.5311/S.2456) Biosimilars Competition Act of 2018 (H.R. 6478) Know the Lowest Price Act of 2018 (S.2553) Patient Right to Know Drug Prices Act (S.2554) SUPPORT for Patients and Communities Act (H.R. 6)
Client expense: $400,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Medicare/Medicaid
Medicare Advantage; Medicare Prior Authorization; Medicaid Rebates; Medicaid Expansion;Medicaid General; CHIP REform; Medicare Access and CHIP Reauthorization Act of 2015 (MACRA); Rate Notice and Call Letter; Medicare part D; Medicaid Alignment; NBPP, Part D Doughnut Hole, RX Rebates, ACE Kid's Act. HR 6 SUPPORT for Patients and Communities Act Introduced June 13, 2018 by Greg Walden (R-OR) includes Medicaid, Medicare and public health reforms to combat the opioid crisis by advancing treatment and revocery initiatives, improving prevention, protecting communities and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 3325 ACE Kids Act Introduced July 20, 2017 by Joe Barton (R-TX) to amend title XIX of the Social Security Act to provide States with the option of providing coordinated care for children with complex medical conditions through a health home and for other purposes. HR 6478 Biosimiliars Competition Act of 2018 Introduced July 23, 2018 by John Sarbanes (D-MD) To enhance competition for prescription drugs by increasing the ability of the Department of Justice and Federal Trade Commission to enforce existing antitrust laws regarding biologic and biosimilar products, and for other purposes. S 2554 Patient Right to Know Drug Price Act of 2018 Introduced March 14, 2018 by Susan Collins (R-ME) Americans overspend by an estimated $135 million on prescriptions through their insurance, in cases when they would cost less out of pocket. Yet pjarmacists are often under gag orders from telling customers about that discrepancy. A new Bill introduced in the Senate would end this practice.
Client expense: $92,595 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Pharmacy
S. 297, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug costs S. 974, CREATES Act (Leahy-Grassley) - access to generic drugs and biosimilars S. 1115, Making Pharmaceutical Markets More Competitive Act (Collins-McCaskill) - accelerated approval of generic therapies S. 1131, FAIR Drug Pricing Act (Baldwin-McCain) - transparency in prescription drug pricing S. 2553, Know the Lowest Price Act (Stabenow) - pharmacist-patient communications, S. 2554, Patient Right to Know Drug Prices Act (Collins) - pharmacist-patient communications, reporting of biosimilar pay-for-delay settlements S. 3194, Capping Prescription Costs Act (Warren) - capping prescription copays H.R. 749, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug costs H.R. 1703, Medical Product Communication Act (Griffith) - off-label exchange of information H.R. 2026, Pharmaceutical Information Exchange Act (Guthrie) - pre-approval health care economic information to payors H.R. 2051, Fair Access for Safe and Timely Generics Act (McKinley-Welch) - access to generic drugs H.R. 2212, CREATES Act (Marino-Cicilline) - access to generic drugs and biosimilars H.R. 2439, FAIR Drug Pricing Act (Schakowsky) - transparency in prescription drug pricing H.R. 2562, Making Pharmaceutical Markets More Competitive Act (Kelly) - accelerated approval of generic therapies H.R. 2999, Patients' Access to Treatments Act (McKinley) - limiting cost sharing in specialty drug tiers H.R. 5247, Right to Try Act (Fitzpatrick) - use of unapproved investigational drugs by patients with life-threatening conditions H.R. 6142, Reducing Drug Waste Act (Doggett) - packaging of medications H.R. 6157, Defense-Labor-HHS-Education Appropriations Act (Granger) -pharmaceutical price transparency in DTC advertising H.R. 6340, Capping Prescription Costs Act (Rosen) - capping prescription copays H.R. 6478, Biosimilars Competition Act (Sarbanes) - reporting of pay-for-delay settlements H.R. 6576, Drug-Price Transparency in Communications Act (Schakowsky) - disclosure of drug prices in DTC advertising H.R. 6733, Know the Cost Act (Carter) - pharmacist-patient communications Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics; issues relating to opioids; issues relating to prescription drug price blueprint; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.
Client expense: $1,500,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of
2018 · third_quarter · Medicare/Medicaid
Medicare Advantage; Medicare Prior Authorization; Medicaid Rebates; Medicaid Expansion; CHIP Reform; Medicare Access & CHIP Reauthorization Act of 2015 (MACRA); Medicare Part D; Medicaid Alignment. HR 6 SUPPORT for Patients and Communities Act Introduced June 13, 2018 by Greg Walden (R-OR) includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 4143 Dialysis Patients Demonstration Act of 2017 Introduced October 26, 2017 by Jason Smith (R-MO) To establish a demonstration program to provide integrated care for Medicare beneficiaries with end-stage renal disease, and for other purposes. HR 6478 Biosimilars Competition Act of 2018 Introduced July 23, 2018 by John Sarbanes (D-MD) To enhance competition for prescription drugs by increasing the ability of the Department of Justice and Federal Trade Commission to enforce existing antitrust laws regarding biologic and biosimilar products, and for other purposes. S 2554 Patient Right to Know Drug Price Act of 2018 Introduced March 14, 2018 by Susan Collins (R-ME) Americans overspend by an estimated $135 million on prescriptions through their insurance, in cases when they would cost less out of pocket. Yet pharmacists are often under gag orders from telling customers about that discrepancy. A new bill introduced in the Senate would end this practice.
Client expense: $40,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
FAST Genetics Act of 2017 (H.R. 2051) CREATES Act of 2017 (H.R. 2212/S. 974) Preserve Access to Affordable Generics Act (S. 124) 340B PAUSE ACT (H.R. 4710) Legislation to place a moratorium on the 340B drug payment cuts in the CY 2018 Outpatient Prospective Payment System Rule (H.R. 4392) Protecting Jessica Grubbs Legacy Act (S. 1850) Overdose Prevention and Patient Safety Act (H.R. 3545, 5795, 6082) ACA Medicaid disproportionate share hospital (DSH) cuts Childrens Health Insurance Program (CHIP) funding ACO Improvement Act of 2017 (H.R. 4580) Medicare Home Infusion Therapy Access Act of 2017 (S. 1738)/ Section 101 of Medicare Part B Improvement Act of 2017 (H.R. 3178) Prescription Drug Price Transparency Act (MAC bill) (H.R.1316) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R.1038/S.413) Ensuring Seniors Access to Local Pharmacies Act of 2017 (H.R.1939/S.1044) Pharmacy and Medically Underserved Areas Enhancement Act (H.R.592/S.109) CARA 2.0 Act of 2018 (H.R.5311/S.2456) Biosimilars Competition Act of 2018 (H.R. 6478) Know the Lowest Price Act of 2018 (S.2553) Patient Right to Know Drug Prices Act (S.2554) SUPPORT for Patients and Communities Act (H.R. 6)
Client expense: $310,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
S.J.RES.63 - A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Secretary of the Treasury, Secretary of Labor, and Secretary of Health and Human Services relating to "Short-Term, Limited Duration Insurance". S.3411 - Affordable Medications Act - comprehensive legislation to address rising prescription drug prices CURE High Drug Prices Act - prevent price gouging by pharmaceutical companies S.3485 - Basic Health Program Expansion Act of 2018 - allow States to expand basic health programs to cover more low-income individuals at lower cost. H.R.5977 - MOMMA's Act - improve Federal efforts with respect to the prevention of maternal mortality H.R.6478 - Biosimilars Competition Act of 2018 - enhance competition for prescription drugs by increasing the ability of the Department of Justice and Federal Trade Commission to enforce existing antitrust laws regarding biologic and biosimilar products S.3194 - Capping Prescription Costs Act of 2018 - cap prescription drug cost-sharing to $250 per month for each enrolled individual, or $500 for each family starting in 2020 H.R.2889 - Closing Loopholes for Orphan Drugs Act - revise the 340B Drug Pricing Program, which currently requires drug manufacturers to discount orphan drugs (drugs for rare conditions) for certain entities covered by the program. The bill discounts orphan drugs that are not being used to treat rare conditions for all entities covered by the program H.R.5942 - Health Equity and Accountability Act of 2018 - lobbied in support of entire bill; specifically lobbied in support of TITLE IV-IMPROVING HEALTH CARE ACCESS AND QUALITY - Subtitle C-Advancing Health Equity Through Payment And Delivery Reform. H.R.2422 - Action for Dental Health Act of 2017 - HHS provides grants to improve essential oral health care for low-income and other underserved individuals by breaking down barriers to care S.974 - CREATES Act of 2017 - facilitate the timely entry of lower-cost generic and biosimilar versions of drugs and biological products S.Res.581 - A resolution authorizing the Senate Legal Counsel to represent the Senate in Texas v. United States, No. 4:18-cv-00167-O (N.D. Tex.) Reducing Costs for Out-of-Network Services Act of 2018 - cap the amount that hospitals and physicians could charge uninsured patients and out-of-network patients who have individual market coverage Surprise billing - draft legislation to prevent surprise medical billing of patients.
Client expense: $30,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · third_quarter · Medicare/Medicaid
Medicare Advantage; Medicare Prior Authorization; Medicaid Rebates; Medicaid Expansion; CHIP Reform; Medicare Access & CHIP Reauthorization Act of 2015 (MACRA); Rate Notice and Call Letter; Medicare Part D; Medicaid Alignment HR 6 SUPPORT for Patients and Communities Act Introduced June 13, 2018 by Greg Walden (R-OR) includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 3325 ACE Kids Act Introduced July 20, 2017 by Joe Barton (R-TX) To amend title XIX of the Social Security Act to provide States with the option of providing coordinated care for children with complex medical conditions through a health home, and for other purposes. HR 4143 Dialysis Patients Demonstration Act of 2017 Introduced October 26, 2017 by Jason Smith (R-MO) To establish a demonstration program to provide integrated care for Medicare beneficiaries with end-stage renal disease, and for other purposes. HR 6478 Biosimilars Competition Act of 2018 Introduced July 23, 2018 by John Sarbanes (D-MD) To enhance competition for prescription drugs by increasing the ability of the Department of Justice and Federal Trade Commission to enforce existing antitrust laws regarding biologic and biosimilar products, and for other purposes. S 2554 Patient Right to Know Drug Price Act of 2018 Introduced March 14, 2018 by Susan Collins (R-ME) Americans overspend by an estimated $135 million on prescriptions through their insurance, in cases when they would cost less out of pocket. Yet pharmacists are often under gag orders from telling customers about that discrepancy. A new bill introduced in the Senate would end this practice.
Client expense: $1,700,000 · 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), Office of the Vice President of the United States, SENATE, Vice President of the U.S., White House Office
2018 · third_quarter · Health Issues
Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 (H.R. 2851/S. 1327); The Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act (i.e., the "SCREEN Act")(H.R. 5228); Opioid Crisis Response Act of 2018 (S. 2680); Expanding Access to Low Cost Generic Drugs Act (S. 2476); Preserve Access to Affordable Generics Act (S. 124); Regulatory exclusivity; Improving Access To Affordable Prescription Drugs Act (S. 771/H.R. 1776); Comprehensive Addiction Resources Emergency Act (CARE Act)(S. 2700/HR 5545); SOUND Disposal and Packaging Act (HR 5687); Long-Term Opioid Efficacy Act of 2018 (HR 5811); SAFETY Act of 2018 (H.R. 5803); Drug pricing; H.R. 5752, the Stop Illicit Drug Importation Act of 2018; proposed legislation regarding tableting and encapsulating opioid products; Drug Importation; CREATES Act (HR 2212/S. 974; 340B issues; SUPPORT for Patients and Communities Act (H.R. 6), Biosimilars Competition Act of 2018 (H.R. 6478), Patient Right to Know Drug Prices Act (S. 2554/H.R. 6143), Re-Valuing Anti-Microbial Products Act of 2018 (H.R. 6294), Medicare Negotiation and Competitive Licensing Act of 2018 (H.R. 6505), Making Objective Drug Evidence Revisions for New (MODERN) Labeling Act (S. 3519), citizen petitions
Client expense: Not reported · Firm income: $270,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
Affordable Healthcare Act (ACA)Regulations; ACA Stabilization; American Health Care Act (AHCA); Health Care Reform; Reinsurance; Health Savings Accounts; Repeal and Replace; Grace Periods; SEPs; Medicare Cost plan; Marketplace Stability; Individual Marketplace Reform; Better Care Reconciliation Act (BCRA), mental health, transparency, HSA HR 633 Patient Fairness and Relief Act of 2017 Introduced by Greg Harper (R-MS) To authorize health indurance issuers to continue to offer for sale health insurance coverage in the individual market before the enactment of the minimum EHB. HR 708 State Age Rating Flexibility Act of 2017 Introduced by Larry Buschon (R-IN) This bill amends the Public Health Service Act to increase the permissible variation based on age for health insurance premiums for coverage offered in the individual or small group market from a factor of three to five, or to be determined by the state. HR 2212 CREATES Act of 2017 HR 6478 Biosimilars Competition Act of 2018 HR 2554 Patient Right to Know Drug Price Act HR 4666 Premium Relief Act of 2017 S 1352 Individual Health Insurance Marketplace Improvement HR 3976 Access to Marketplace Insurance Act Poioid epidemic: CREATS Act, Drug Pricing; PBM/Prescription Drug Costs Rx Rebates; Direct-to-consumer advertising
Client expense: $37,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
H.R.6586 - Reducing Obesity in Youth Act of 2018 H.R.6 - SUPPORT for Patients and Communities Act: Neonatal Abstinence Syndrome & Pediatric Telehealth HR 6478 Emergency Medical Services for Children Program Reauthorization Act CHGME Reauthorization: S.2597 - Children's Hospital GME Support Reauthorization Act of 2018 & H.R.5385 - Dr. Benjy Frances Brooks Children's Hospital GME Support Reauthorization Act of 2018 (became law) Pediatric Research policies Pediatric Telehealth policies Pediatric loan repayment for pediatric subspecialists (Sec 775 o PHSA) as part o title VII Reauthorizations
Client expense: $150,091 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Medicare/Medicaid
Medicare Advantage; Medicare Prior Authorization; Medicaid Rebates; Medicaid Expansion; CHIP Reform; Medicare Access & CHIP Reauthorization Act of 2015 (MACRA); Rate Notice and Call Letter; Medicare Part D HR 6 Introduced June 13, 2018 by Greg Walden (R-OR). The SUPPORT for Patients and Communities Act includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 3325 Introduced July 20, 2017 by Joe Barton (R-TX). This bill amends title XIX of the Social Security Act to provide states with the option of providing coordinated care for children with complex medical conditions through a health home, and for other purposes. HR 4143 Introduced October 26, 2017 by Jason Smith (R-MO). The Dialysis Patients Demonstration Act of 2017 establishes a demonstration program to provide integrated care for Medicare beneficiaries with end-stage renal disease, and for other purposes. HR 6478 Introduced July 23, 2018 by John Sarbanes (D-MD). The Biosimilars Competition Act of 2018 enhances competition for prescription drugs by increasing the ability of the Department of Justice and Federal Trade Commission to enforce existing antitrust laws regarding biologic and biosimilar products, and for other purposes. S 2554 Introduced March 14, 2018 by Susan Collins (R-ME). The Patient Right to Know Drug Price Act of 2018. Americans overspend by an estimated $135 million on prescriptions through their insurance, in cases where their drugs would cost less out of pocket. Yet pharmacists are often under gag orders from telling customers about that discrepancy. This bill would end this practice.
Client expense: Not reported · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · third_quarter · Medicare/Medicaid
Medicare Advantage; Medicare Prior Authorization; Medicaid Rebates; Medicaid Expansion; CHIP Reform; Medicare Access & CHIP Reauthorization Act of 2015 (MACRA); Rate Notice and Call Letter; Medicare Part D HR 6 Introduced June 13, 2018 by Greg Walden (R-OR). The SUPPORT for Patients and Communities Act includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 3325 Introduced July 20, 2017 by Joe Barton (R-TX). This bill amends title XIX of the Social Security Act to provide states with the option of providing coordinated care for children with complex medical conditions through a health home, and for other purposes. HR 4143 Introduced October 26, 2017 by Jason Smith (R-MO). The Dialysis Patients Demonstration Act of 2017 establishes a demonstration program to provide integrated care for Medicare beneficiaries with end-stage renal disease, and for other purposes. HR 6478 Introduced July 23, 2018 by John Sarbanes (D-MD). The Biosimilars Competition Act of 2018 enhances competition for prescription drugs by increasing the ability of the Department of Justice and Federal Trade Commission to enforce existing antitrust laws regarding biologic and biosimilar products, and for other purposes. S 2554 Introduced March 14, 2018 by Susan Collins (R-ME). The Patient Right to Know Drug Price Act of 2018. Americans overspend by an estimated $135 million on prescriptions through their insurance, in cases where their drugs would cost less out of pocket. Yet pharmacists are often under gag orders from telling customers about that discrepancy. This bill would end this practice.
Client expense: $300,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE