Cancer Drug Parity Act of 2017

H.R. 1409 The Cancer Drug Parity Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Bipartisan Health Care Stabilization Act (Alexander-Murray) - funding for cost sharing reduction benefits, stabilization of individual market Bipartisan Health Care Stabilization Act; updated version (Alexander-Walden-Collins-Costello) - funding for cost sharing reduction benefits and reinsurance, stabilization of individual market S. 147, Obamacare Taxpayer Bailout Prevention Act (Rubio) - ACA risk corridors program S. 581, Jessies Law (Manchin-Capito) - patient history of opioid use disorder S. 1201, Health Care Options for All Act (McCaskill) - coverage options in bare counties S. 1354, Individual Health Insurance Marketplace Improvement Act (Carper-Kaine) - individual market reinsurance fund, outreach and enrollment activities S. 1462, Marketplace Certainty Act (Shaheen) - funding for cost-sharing reduction benefits S. 1516, Coverage Across State Lines (Heller) S. 1667, Protecting Consumers from Unreasonable Rates Act (Feinstein) - rate review S. 1835, Lower Premiums Through Reinsurance Act (Collins-Nelson) - invisible high risk pool and reinsurance programs S. 1976, Increasing Access to Care Act (Scott) - copper plan S. 1985, Protect Access to Birth Control Act (Murray) - coverage of contraceptive services S. 2052, Healthcare Market Certainty and Mandate Relief Act (Hatch) - funding for cost sharing reduction benefits, HSA improvements, ACA individual mandate S. 2241 (King) - fees on excepted benefits and standalone dental plans S. 2303, Access to Independent Health Insurance Advisors Act (Isakson-Coons) - calculation of medical loss ratios S. 3388, Ensuring Coverage for Patients with Pre-Existing Conditions Act (Tillis) - protections for individuals with pre-existing conditions S. 3541, Reducing Costs for Out-of-Network Services Act (Shaheen) -cost-sharing for out-of-network services S. 3592, No More Surprise Medical Bills Act (Hassan) - surprise medical bills S. 3742, Cancer Drug Parity Act (Smith) - cost sharing for cancer drugs H.R. 2, Agriculture and Nutrition Act (Conaway) - agricultural association health plans H.R. 314, Health Care Choice Act (Blackburn) - selling insurance across state lines H.R. 372, Competitive Health Insurance Reform Act (Gosar) - McCarran-Ferguson Act H.R. 421, Allowing Greater Access to Safe and Effective Contraception Act (Love) - non-prescription contraceptives, HSA flexibility H.R. 706, Plan Verification and Fairness Act (Blackburn) - verifying eligibility for special enrollment periods H.R. 708, State Age Rating Flexibility Act (Buchson) - age rating bands H.R. 710, Health Coverage State Flexibility Act (Flores) - grace period for premium payments H.R. 1101, Small Business Health Fairness Act (Johnson) - association health plans H.R. 1121, Pre-existing Conditions Protection Act (Walden) - protections for patients with pre-existing conditions H.R. 1304, Self-Insurance Protection Act (Roe) - medical stop-loss insurance H.R. 1409, Cancer Drug Parity Act (Lance) - coverage of oral anti-cancer drugs H.R. 1606, DOC Access Act (Carter) - reimbursement for dental and vision providers H.R. 3450, Protecting Consumers from Unreasonable Rates Act (Schakowsky) - rate review H.R. 3545, Overdose Prevention and Patient Safety Act (Murphy- Blumenauer) -- confidentiality of drug and alcohol treatment and prevention records H.R. 3976, Access to Marketplace Insurance Act (Cramer) - third party payments H.R. 4082, Protect Access to Birth Control Act (DeGette) - coverage of contraceptive services H.R. 4200, Healthcare Market Certainty and Mandate Relief Act (Brady) - funding for cost sharing reduction benefits, HSA improvements H.R. 4225 (Hudson) - fees on excepted benefits and standalone dental plans H.R. 4575, Access to Independent Health Insurance Advisors Act (Long-Schrader) - calculation of medical loss ratios H.R. 4666, Premium Relief Act (Costello) - Patient and State Stability Fund H.R. 4695, Bipartisan Market Stabilization and Innovation Act (Schrader) - stabilization of individual market H.R. 6311, Increasing Access to Lower Premium Plans and Expanding Health Savings Accounts Act (Roskam) - access to catastrophic plans, definition of qualified health plans H.R. 6314, Health Savings Act (Burgess) - definition of high-deductible health plan H.R. 6496, Continuing Coverage for Preexisting Conditions Act (Joyce) - protections for individuals with pre-existing conditions H.R. 7003, Federal Invisible Risk Sharing Program (Schweikert) Regulatory Issues: Insurance regulatory reform; issues related to the coordination of private and public disability income benefits; disability risk management; disability income insurance enrollment and awareness; issues related to encouraging impaired workers to stay in/return to the workforce; issues related to expanding long-term care insurance coverage; issues relating to the coordination of benefits between private health insurance plans and Medicaid; Medigap claims processing and crossover fees; Medigap cross-over claim issues, Medigap coverage, implementation of Medigap standardized plan offerings; Medigap carrier recoveries related to CMS fraud and abuse enforcement activities, and issues related to Medigap educational materials, and other Medigap issues; fraud and abuse issues affecting public and private insurance coverage; issues relating to antitrust; implementation of the Mental Health Parity Act requirements; implementation of the 21st Century Cures Act requirements; summary of benefits and coverage disclosures; pre-existing condition insurance plans; accountable care organizations; coverage of preventive services; preexisting condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; health reimbursement accounts; dependent coverage; treatment of expatriate plans; issues related to all payor claims databases; issues related to association health plans; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations, non-discriminatory wellness programs; issues related to supplemental products; issues relating to dental coverage; issues relating to proposals for single-payer and Medicare/Medicaid buy-in options; issues related to implementation of the Telephone Consumer Protection Act; issues relating to third party payment of premiums; issues related to cost-sharing reductions (CSRs); issues relating to the individual market; 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

H.R.1409 - Cancer Drug Parity Act of 2017 H.R.820/ S. 292 - Childhood Cancer STAR Act H.R.1231/S. 456 - RACE for Children Act H.R.1676/S. 693 - Palliative Care and Hospice Education and Training Act H.R.878 - Right to Try Act of 2017 S.204 - Trickett Wendler Right to Try Act of 2017 H.R.1854/ S. 778 - Prescription Drug Monitoring Act of 2017 Diagnostic Accuracy and Innovation Act (DAIA)(Draft legislation) H.R. 2430 FDA Reauthorization Act S. 934 FDA Reauthorization Act H.R. 2797/ S.1334Patient Choice and Quality Care Act (PCQCA) H.R. 2999Patient's Access to Treatment Act (PATA) H.R. 1628Better Care Reconciliation Act (BCRA) H.R. 1316Prescription Drug Pricing Transparency Act H.R. 2077 Restoring Patients Voices Act

Client expense: $79,366 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.1409/S.3742, Cancer Drug Parity Act of 2017, advocate for equitable coverage of cancer therapies; H.R.2999, Patients Access to Treatment Act, advocate for access to cancer therapies; H.R.4978, Chronic Disease Management Act of 2018; H.R.3388, Ensuring Coverage for Patients with Pre-Existing Conditions Act.

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

H.R. 2051, "FAST Generics Act of 2017", provisions regarding REMS. H.R. 1409, "Cancer Drug Parity Act of 2017", regarding all provisions. H.R. 2077, "Restoring the Patient's Voice Act of 2017", Step Therapy / Fail First. S. 974/ H.R. 2212, "CREATES Act of 2017", provisions regarding REMS. Issues relating to Cancer Drug Coverage Parity. Issues relating to Step Therapy / Fail First. Issues relating to Medicare Part D / Part B. Issues relating to Reimbursement for and patient access to Chimeric Antigen Receptor (CAR) T-cell therapies.

Client expense: $400,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FY19 Appropriations for NIH, CDC, and DoD ovarian cancer programs. Supporting H.R.1409 - Cancer Drug Parity Act of 2017. Supporting the re-authorization of Johanna's Law.

Client expense: Not reported · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, SENATE

HR 1409, Cancer Drug Coverage Parity Act

Client expense: Not reported · Firm income: $30,000

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE

Sickle Cell Disease Research, Surveillance, Prevention, and Treatment Act of 2017 (H.R. 2410) Sickle Cell Disease Research, Surveillance, Prevention, and Treatment Act of 2018/Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2018 (S. 2465) Cancer Drug Parity Act (H.R. 1409/S. 3742) Patients Access to Treatment Act (H.R. 2999) Implementation of Patient Protection and Affordable Care Act (P.L. 111-148) Repeal of Patient Protection and Affordable Care Act (P.L. 111-148) Hematology and Oncology Drug Research and Approval Issues Implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) (P.L. 112-144) Clinical trials regulations and coverage Issues impacting coverage for hematologic diseases and conditions Reimbursement for CAR-T and immunotherapies Issues impacting opioid access/use for patients with hematologic diseases and disorders

Client expense: $30,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

Bipartisan Health Care Stabilization Act (Alexander-Murray) - funding for cost sharing reduction benefits, stabilization of individual market Bipartisan Health Care Stabilization Act; updated version (Alexander-Walden-Collins-Costello) - funding for cost sharing reduction benefits and reinsurance, stabilization of individual market S. 147, Obamacare Taxpayer Bailout Prevention Act (Rubio) - ACA risk corridors program S. 581, Jessies Law (Manchin-Capito) - patient history of opioid use disorder S. 1201, Health Care Options for All Act (McCaskill) - coverage options in bare counties S. 1354, Individual Health Insurance Marketplace Improvement Act (Carper-Kaine) - individual market reinsurance fund, outreach and enrollment activities S. 1462, Marketplace Certainty Act (Shaheen) - funding for cost-sharing reduction benefits S. 1516, Coverage Across State Lines (Heller) S. 1667, Protecting Consumers from Unreasonable Rates Act (Feinstein) - rate review S. 1835, Lower Premiums Through Reinsurance Act (Collins-Nelson) - invisible high risk pool and reinsurance programs S. 1976, Increasing Access to Care Act (Scott) - copper plan S. 1985, Protect Access to Birth Control Act (Murray) - coverage of contraceptive services S. 2052, Healthcare Market Certainty and Mandate Relief Act (Hatch) - funding for cost sharing reduction benefits, HSA improvements, ACA individual mandate S. 2241 (King) - fees on excepted benefits and standalone dental plans S. 2303, Access to Independent Health Insurance Advisors Act (Isakson-Coons) - calculation of medical loss ratios S. 3388, Ensuring Coverage for Patients with Pre-Existing Conditions Act (Tillis) - protections for individuals with pre-existing conditions S. 3541, Reducing Costs for Out-of-Network Services Act (Shaheen) -cost-sharing for out-of-network services S. 3592, No More Surprise Medical Bills Act (Hassan) - surprise medical bills S. 3742, Cancer Drug Parity Act (Smith) - cost sharing for cancer drugs H.R. 2, Agriculture and Nutrition Act (Conaway) - agricultural association health plans H.R. 314, Health Care Choice Act (Blackburn) - selling insurance across state lines H.R. 372, Competitive Health Insurance Reform Act (Gosar) - McCarran-Ferguson Act H.R. 421, Allowing Greater Access to Safe and Effective Contraception Act (Love) - non-prescription contraceptives, HSA flexibility H.R. 706, Plan Verification and Fairness Act (Blackburn) - verifying eligibility for special enrollment periods H.R. 708, State Age Rating Flexibility Act (Buchson) - age rating bands H.R. 710, Health Coverage State Flexibility Act (Flores) - grace period for premium payments H.R. 1101, Small Business Health Fairness Act (Johnson) - association health plans H.R. 1121, Pre-existing Conditions Protection Act (Walden) - protections for patients with pre-existing conditions H.R. 1304, Self-Insurance Protection Act (Roe) - medical stop-loss insurance H.R. 1409, Cancer Drug Parity Act (Lance) - coverage of oral anti-cancer drugs H.R. 1606, DOC Access Act (Carter) - reimbursement for dental and vision providers H.R. 3450, Protecting Consumers from Unreasonable Rates Act (Schakowsky) - rate review H.R. 3545, Overdose Prevention and Patient Safety Act (Murphy- Blumenauer) -- confidentiality of drug and alcohol treatment and prevention records H.R. 3976, Access to Marketplace Insurance Act (Cramer) - third party payments H.R. 4082, Protect Access to Birth Control Act (DeGette) - coverage of contraceptive services H.R. 4200, Healthcare Market Certainty and Mandate Relief Act (Brady) - funding for cost sharing reduction benefits, HSA improvements H.R. 4225 (Hudson) - fees on excepted benefits and standalone dental plans H.R. 4575, Access to Independent Health Insurance Advisors Act (Long-Schrader) - calculation of medical loss ratios H.R. 4666, Premium Relief Act (Costello) - Patient and State Stability Fund H.R. 4695, Bipartisan Market Stabilization and Innovation Act (Schrader) - stabilization of individual market H.R. 6311, Increasing Access to Lower Premium Plans and Expanding Health Savings Accounts Act (Roskam) - access to catastrophic plans, definition of qualified health plans H.R. 6314, Health Savings Act (Burgess) - definition of high-deductible health plan H.R. 6496, Continuing Coverage for Preexisting Conditions Act (Joyce) - protections for individuals with pre-existing conditions H.R. 7003, Federal Invisible Risk Sharing Program (Schweikert) Regulatory Issues: Insurance regulatory reform; issues related to the coordination of private and public disability income benefits; disability risk management; disability income insurance enrollment and awareness; issues related to encouraging impaired workers to stay in/return to the workforce; issues related to expanding long-term care insurance coverage; issues relating to the coordination of benefits between private health insurance plans and Medicaid; Medigap claims processing and crossover fees; Medigap cross-over claim issues, Medigap coverage, implementation of Medigap standardized plan offerings; Medigap carrier recoveries related to CMS fraud and abuse enforcement activities, and issues related to Medigap educational materials, and other Medigap issues; fraud and abuse issues affecting public and private insurance coverage; issues relating to antitrust; implementation of the Mental Health Parity Act requirements; implementation of the 21st Century Cures Act requirements; summary of benefits and coverage disclosures; pre-existing condition insurance plans; accountable care organizations; coverage of preventive services; preexisting condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; health reimbursement accounts; dependent coverage; treatment of expatriate plans; issues related to all payor claims databases; issues related to association health plans; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations, non-discriminatory wellness programs; issues related to supplemental products; issues relating to dental coverage; issues relating to proposals for single-payer and Medicare/Medicaid buy-in options; issues related to implementation of the Telephone Consumer Protection Act; issues relating to third party payment of premiums; issues related to cost-sharing reductions (CSRs); issues relating to the individual market; and other issues relating to health care reform implementation.

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

Issues relating to access to care, health disparities, childhood cancer, quality of life and palliative care, federal health care programs, genetic information, cancer, nutrition, tanning beds, clinical trials, skin cancer, and wellness, including: H.R.1676 & S.693, the Palliative Care and Hospice Education and Training Act; H.R. 4122 & S. 2006, the Breast Density & Mammography Reporting Act; and H.R.820 & S.292, the Childhood Cancer STAR Act. Issues relating to anti-cancer medication cost-sharing parity respecting H.R. 1409. Issues regarding a national family caregiving strategy respecting S. 1719 and H.R. 1028. Issues regarding access to medicines respecting S.204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, as well as H.R.878, the Right to Try Act of 2017. Issues regarding lymphedema treatment respecting The Lymphedema Treatment Act, H.R. 930 and S. 497. The proposed Medical Records Fairness Act (no number yet). Issues regarding the Affordable Care Act premium tax credits and catastrophic plans, HR 6311. Issues regarding protections for people with pre-existing conditions, including S. 3388, HR 6898, and H. Res. 1066. Resolutions to disapprove the short-term rule, H.J. Res 140 and S. J. Res. 63. Advocacy against including the Association Health Plan provision of the House Farm bill in the conference report, H.R. 2 and s. 3042 (section 6004 of the House-passed version of the legislation). Issues involving patient navigation, including the Patient Navigation Assistance Act, HR 6808. H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, respecting Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, and protecting communities. Draft legislation on patient access to medical records. Draft legislation on FDA regulation of laboratory tests, Verifying Accurate Leading-edge IVCT Development Act of 2018 or the VALID Act of 2018. H.R. 4897 & S. 2358 Women and Lung Cancer Research and Preventive Services Act of 2018. Issues related to caregiving, including H.R. 3759/S. 1028, the RAISE Family Caregivers Act, H. Res. 282, supporting initiatives to encourage parents and guardians to take measures to prevent sunburns in minors they care for.

Client expense: $1,610,710 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office

Monitoring healthcare regulations and legislation; Palliative Care Hospice Education and Treatment Act PCHETA (H.R. 1676/S. 693); Oral Cancer Drug Parity Act (H.R. 1409);Title VIII Nursing Workforce Reauthorization Act (H.R. 959; Lymphedema Treatment Act (HR 930, S497); Cancer Communications and Planning Act (HR 5160)

Client expense: $120,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE

Issues related to blood cancer research, diagnosis, treatment and cures including coverage and reimbursement of cancer treatment therapies and issues related to H. R.1409 the Cancer Drug Parity Act of 2017. Issues related to patient protections for blood cancer patients. Issues related to insurance market stabilization. Issues related to pediatric cancer, including H. R. 820, the Childhood Cancer STAR Act, and it's Senate companion S.292, the Childhood Cancer Survivorship, Treatment Access, and Research Act of 2018. Issues related to Health Savings Accounts. Issues related to Short-Term Limited Duration health insurance plans.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Regulatory and reimbursement policy issues related to federal healthcare programs, including Medicare and Medicaid. Medicare reimbursement for transformative therapies. H.R. 1409, the "Cancer Drug Parity Act". H.R. 2051, the "FAST Generics Act". H.R. 2077, the "Restoring the Patient's Voice Act". H.R. 6157, "Department of Defense and Labor, Health and Human Services, and Education Appropriations Act". H.R. 6, "SUPPORT for Patients and Communities Act".

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Cancer Drug Parity Act (HR 1409); RxCAP Act of 2017 (S 1347); the FAIR Care Act (S 2494); Patient Advocacy Transparency Act (S. 3000); HHS guidance on ACA section 1332 waivers; pediatric cancer research

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

H.R. 1409 Cancer Drug Parity Act of 2017 H.R. 4978 Chronic Disease Management Act of 2018 S. 3388 Ensuring Coverage for Patients with Pre-Existing Conditions Act

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1409 The Cancer Drug Parity Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Social Security Disability Fairness Act Right to Try Act Healthcare Benefits & Access Healthcare Reform, Patient Protections HR 1409 HR 6114

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FY19 Appropriations for NIH, CDC, and DoD ovarian cancer programs. Supporting H.R.1409 - Cancer Drug Parity Act of 2017. Supporting the re-authorization of Johanna's Law.

Client expense: Not reported · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, SENATE

H.R.1409 - Cancer Drug Parity Act of 2017 H.R.820/ S. 292 - Childhood Cancer STAR Act H.R.1231/S. 456 - RACE for Children Act H.R.1676/S. 693 - Palliative Care and Hospice Education and Training Act H.R.878 - Right to Try Act of 2017 S.204 - Trickett Wendler Right to Try Act of 2017 H.R.1854/ S. 778 - Prescription Drug Monitoring Act of 2017 Diagnostic Accuracy and Innovation Act (DAIA)(Draft legislation) H.R. 2430 FDA Reauthorization Act S. 934 FDA Reauthorization Act H.R. 2797/ S.1334Patient Choice and Quality Care Act (PCQCA) H.R. 2999Patient's Access to Treatment Act (PATA) H.R. 1628Better Care Reconciliation Act (BCRA) H.R. 1316Prescription Drug Pricing Transparency Act H.R. 2077 Restoring Patients Voices Act

Client expense: $223,857 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.1409, Cancer Drug Parity Act of 2017, advocate for equitable coverage of cancer therapies; H.R.2999, Patients Access to Treatment Act, advocate for access to cancer therapies; H.R.4978, Chronic Disease Management Act of 2018; H.R.3388, Ensuring Coverage for Patients with Pre-Existing Conditions Act.

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

H.R. 2051, "FAST Generics Act of 2017", provisions regarding REMS. H.R. 1409, "Cancer Drug Parity Act of 2017", regarding all provisions. H.R. 2077, "Restoring the Patient's Voice Act of 2017", Step Therapy / Fail First. S. 974/ H.R. 2212, "CREATES Act of 2017", provisions regarding REMS. Issues relating to Cancer Drug Coverage Parity. Issues relating to Step Therapy / Fail First. Issues relating to Medicare Part D / Part B. Issues relating to Medicare Reimbursement for Transformative Therapies.

Client expense: $790,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to access to care, health disparities, childhood cancer, quality of life and palliative care, federal health care programs, genetic information, cancer, nutrition, tanning beds, skin cancer, and wellness, including: H.R.1676 & S.693, the Palliative Care and Hospice Education and Training Act; H.R. 4122 & S. 2006, the Breast Density & Mammography Reporting Act; H.R.820 & S.292, the Childhood Cancer STAR Act; and, H.R. 1231 & S. 456, the RACE for Children Act. In addition, issues related to reform of laboratory and diagnostic tests and the development of a new discussion draft for the Diagnostic Accuracy and Innovation Act; and H.R.772 and S.261, the Common Sense Nutrition Disclosure Act. Issues relating to anti-cancer medication cost-sharing parity respecting H.R. 1409. Issues regarding a national family caregiving strategy respecting S. 1719 and H.R. 1028. Issues regarding access to medicines respecting S.204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, as well as H.R.878, the Right to Try Act of 2017. Issues regarding lymphedema treatment respecting The Lymphedema Treatment Act, H.R. 930 and S. 497. The proposed Medical Records Fairness Act (no number yet). Issues regarding the Affordable Care Act premium tax credits and catastrophic plans, HR 6311. Issues regarding protections for people with pre-existing conditions, including S. 3388, HR 6898, and H. Res. 1066. Resolutions to disapprove the short-term rule, H.J. Res 140 and S. J. Res. 63. Advocacy against including the Association Health Plan provision of the House Farm bill in the conference report, H.R. 2 and s. 3042 (section 6004 of the House-passed version of the legislation). Issues involving patient navigation, including the Patient Navigation Assistance Act, HR 6808. H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, respecting Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, and protecting communities. Draft legislation on patient access to medical records. Draft legislation on FDA regulation of laboratory tests. H.R. 4897 & S. 2358 Women and Lung Cancer Research and Preventive Services Act of 2018. Issues related to caregiving, including H.R. 3759/S. 1028, the RAISE Family Caregivers Act.

Client expense: $1,230,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Energy, Dept of, Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office

Bipartisan Health Care Stabilization Act (Alexander-Murray) - funding for cost sharing reduction benefits, stabilization of individual market Bipartisan Health Care Stabilization Act; updated version (Alexander-Walden-Collins-Costello) - funding for cost sharing reduction benefits and reinsurance, stabilization of individual market S. 147, Obamacare Taxpayer Bailout Prevention Act (Rubio) - ACA risk corridors program S. 581, Jessies Law (Manchin-Capito) - patient history of opioid use disorder S. 1201, Health Care Options for All Act (McCaskill) - coverage options in bare counties S. 1354, Individual Health Insurance Marketplace Improvement Act (Carper-Kaine) - individual market reinsurance fund, outreach and enrollment activities S. 1462, Marketplace Certainty Act (Shaheen) - funding for cost-sharing reduction benefits S. 1516, Coverage Across State Lines (Heller) S. 1667, Protecting Consumers from Unreasonable Rates Act (Feinstein) - rate review S. 1835, Lower Premiums Through Reinsurance Act (Collins-Nelson) - invisible high risk pool and reinsurance programs S. 1850, Legacy Act (Manchin-Capito) -- confidentiality of drug and alcohol treatment and prevention records S. 1976, Increasing Access to Care Act (Scott) - copper plan S. 1985, Protect Access to Birth Control Act (Murray) - coverage of contraceptive services S. 2052, Healthcare Market Certainty and Mandate Relief Act (Hatch) - funding for cost sharing reduction benefits, HSA improvements, ACA individual mandate S. 2241 (King) - fees on excepted benefits and standalone dental plans S. 2303, Access to Independent Health Insurance Advisors Act (Isakson-Coons) - calculation of medical loss ratios S. 3388, Ensuring Coverage for Patients with Pre-Existing Conditions Act (Tillis) - protections for individuals with pre-existing conditions H.R. 2, Agriculture and Nutrition Act (Conaway) - agricultural association health plans H.R. 314, Health Care Choice Act (Blackburn) - selling insurance across state lines H.R. 372, Competitive Health Insurance Reform Act (Gosar) - McCarran-Ferguson Act H.R. 421, Allowing Greater Access to Safe and Effective Contraception Act (Love) - non-prescription contraceptives, HSA flexibility H.R. 706, Plan Verification and Fairness Act (Blackburn) - verifying eligibility for special enrollment periods H.R. 708, State Age Rating Flexibility Act (Buchson) - age rating bands H.R. 710, Health Coverage State Flexibility Act (Flores) - grace period for premium payments H.R. 1101, Small Business Health Fairness Act (Johnson) - association health plans H.R. 1121, Pre-existing Conditions Protection Act (Walden) - protections for patients with pre-existing conditions H.R. 1304, Self-Insurance Protection Act (Roe) - medical stop-loss insurance H.R. 1409, Cancer Drug Parity Act (Lance) - coverage of oral anti-cancer drugs H.R. 1606, DOC Access Act (Carter) - reimbursement for dental and vision providers H.R. 3450, Protecting Consumers from Unreasonable Rates Act (Schakowsky) - rate review H.R. 3545, Overdose Prevention and Patient Safety Act (Murphy- Blumenauer) -- confidentiality of drug and alcohol treatment and prevention records H.R. 3976, Access to Marketplace Insurance Act (Cramer) - third party payments H.R. 4082, Protect Access to Birth Control Act (DeGette) - coverage of contraceptive services H.R. 4200, Healthcare Market Certainty and Mandate Relief Act (Brady) - funding for cost sharing reduction benefits, HSA improvements H.R. 4225 (Hudson) - fees on excepted benefits and standalone dental plans H.R. 4575, Access to Independent Health Insurance Advisors Act (Long-Schrader) - calculation of medical loss ratios H.R. 4666, Premium Relief Act (Costello) - Patient and State Stability Fund H.R. 4695, Bipartisan Market Stabilization and Innovation Act (Schrader) - stabilization of individual market H.R. 6311, Increasing Access to Lower Premium Plans and Expanding Health Savings Accounts Act (Roskam) - access to catastrophic plans, definition of qualified health plans H.R. 6314, Health Savings Act (Burgess) - definition of high-deductible health plan H.R. 6496, Continuing Coverage for Preexisting Conditions Act (Joyce) - protections for individuals with pre-existing conditions H.R. 7003, Federal Invisible Risk Sharing Program (Schweikert) Regulatory Issues: Insurance regulatory reform; issues related to the coordination of private and public disability income benefits; disability risk management; disability income insurance enrollment and awareness; issues related to encouraging impaired workers to stay in/return to the workforce; issues related to expanding long-term care insurance coverage; issues relating to the coordination of benefits between private health insurance plans and Medicaid; Medigap claims processing and crossover fees; Medigap cross-over claim issues, Medigap coverage, implementation of Medigap standardized plan offerings; Medigap carrier recoveries related to CMS fraud and abuse enforcement activities, and issues related to Medigap educational materials, and other Medigap issues; fraud and abuse issues affecting public and private insurance coverage; issues relating to antitrust; implementation of the Mental Health Parity Act requirements; implementation of the 21st Century Cures Act requirements; summary of benefits and coverage disclosures; pre-existing condition insurance plans; accountable care organizations; coverage of preventive services; preexisting condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; dependent coverage; treatment of expatriate plans; issues related to all payor claims databases; issues related to association health plans; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations, non-discriminatory wellness programs; issues related to supplemental products; issues relating to dental coverage; issues relating to proposals for single-payer and Medicare/Medicaid buy-in options; issues related to implementation of the Telephone Consumer Protection Act; issues relating to third party payment of premiums; issues related to cost-sharing reductions (CSRs); issues relating to the individual market; 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

Bipartisan Health Care Stabilization Act (Alexander-Murray) - funding for cost sharing reduction benefits, stabilization of individual market Bipartisan Health Care Stabilization Act; updated version (Alexander-Walden-Collins-Costello) - funding for cost sharing reduction benefits and reinsurance, stabilization of individual market S. 147, Obamacare Taxpayer Bailout Prevention Act (Rubio) - ACA risk corridors program S. 581, Jessies Law (Manchin-Capito) - patient history of opioid use disorder S. 1201, Health Care Options for All Act (McCaskill) - coverage options in bare counties S. 1354, Individual Health Insurance Marketplace Improvement Act (Carper-Kaine) - individual market reinsurance fund, outreach and enrollment activities S. 1405, FAA Reauthorization Act (Thune) - air ambulance issues S. 1462, Marketplace Certainty Act (Shaheen) - funding for cost-sharing reduction benefits S. 1516, Coverage Across State Lines (Heller) S. 1667, Protecting Consumers from Unreasonable Rates Act (Feinstein) - rate review S. 1835, Lower Premiums Through Reinsurance Act (Collins-Nelson) - invisible high risk pool and reinsurance programs S. 1850, Legacy Act (Manchin-Capito) -- confidentiality of drug and alcohol treatment and prevention records S. 1976, Increasing Access to Care Act (Scott) - copper plan S. 1985, Protect Access to Birth Control Act (Murray) - coverage of contraceptive services S. 2052, Healthcare Market Certainty and Mandate Relief Act (Hatch) - funding for cost sharing reduction benefits, HSA improvements, ACA individual mandate S. 2241 (King) - fees on excepted benefits and standalone dental plans S. 2303, Access to Independent Health Insurance Advisors Act (Isakson-Coons) - calculation of medical loss ratios H.R. 2, Agriculture and Nutrition Act (Conaway) - agricultural association health plans H.R. 4, FAA Reauthorization Act (Shuster) - air ambulance issues H.R. 314, Health Care Choice Act (Blackburn) - selling insurance across state lines H.R. 372, Competitive Health Insurance Reform Act (Gosar) - McCarran-Ferguson Act H.R. 421, Allowing Greater Access to Safe and Effective Contraception Act (Love) - non-prescription contraceptives, HSA flexibility H.R. 706, Plan Verification and Fairness Act (Blackburn) - verifying eligibility for special enrollment periods H.R. 708, State Age Rating Flexibility Act (Buchson) - age rating bands H.R. 710, Health Coverage State Flexibility Act (Flores) - grace period for premium payments H.R. 1101, Small Business Health Fairness Act (Johnson) - association health plans H.R. 1121, Pre-existing Conditions Protection Act (Walden) - protections for patients with pre-existing conditions H.R. 1304, Self-Insurance Protection Act (Roe) - medical stop-loss insurance H.R. 1409, Cancer Drug Parity Act (Lance) - coverage of oral anti-cancer drugs H.R. 3450, Protecting Consumers from Unreasonable Rates Act (Schakowsky) - rate review H.R. 3545, Overdose Prevention and Patient Safety Act (Murphy- Blumenauer) -- confidentiality of drug and alcohol treatment and prevention records H.R. 3922, CHAMPION Act (Walden) - extension of federal CHIP funding, ACA grace periods, community health center funding H.R. 3976, Access to Marketplace Insurance Act (Cramer) - third party payments H.R. 4082, Protect Access to Birth Control Act (DeGette) - coverage of contraceptive services H.R. 4200, Healthcare Market Certainty and Mandate Relief Act (Brady) - funding for cost sharing reduction benefits, HSA improvements H.R. 4225 (Hudson) - fees on excepted benefits and standalone dental plans H.R. 4575, Access to Independent Health Insurance Advisors Act (Long-Schrader) - calculation of medical loss ratios H.R. 4666, Premium Relief Act (Costello) - Patient and State Stability Fund H.R. 4695, Bipartisan Market Stabilization and Innovation Act (Schrader) - stabilization of individual market H.R. 6314, Health Savings Act (Burgess) - definition of high-deductible health plan Regulatory Issues: Insurance regulatory reform; issues related to the coordination of private and public disability income benefits; disability risk management; disability income insurance enrollment and awareness; issues related to encouraging impaired workers to stay in/return to the workforce; issues relating to the coordination of benefits between private health insurance plans and Medicaid; Medigap claims processing and crossover fees; Medigap cross-over claim issues, Medigap coverage, implementation of Medigap standardized plan offerings; Medigap carrier recoveries related to CMS fraud and abuse enforcement activities, and issues related to Medigap educational materials, and other Medigap issues; fraud and abuse issues affecting public and private insurance coverage; issues relating to antitrust; implementation of the Mental Health Parity Act requirements; implementation of the 21st Century Cures Act requirements; summary of benefits and coverage disclosures; pre-existing condition insurance plans; accountable care organizations; coverage of preventive services; preexisting condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; dependent coverage; treatment of expatriate plans; issues related to all payor claims databases; issues related to association health plans; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations, non-discriminatory wellness programs; issues related to supplemental products; issues relating to dental coverage; issues relating to proposals for single-payer and Medicare/Medicaid buy-in options; issues related to implementation of the Telephone Consumer Protection Act; issues relating to third party payment of premiums; issues related to cost-sharing reductions (CSRs); issues relating to the individual market; and other issues relating to health care reform implementation.

Client expense: $1,410,000 · 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), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

H.R. 1409 Cancer Drug Parity Act of 2017 H.R. 4978 Chronic Disease Management Act of 2018 S. 3388 Ensuring Coverage for Patients with Pre-Existing Conditions Act

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Cancer Drug Parity Act (HR 1409); the Right to Try Act (S 204, HR 878); the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 (HR 5247); Patients' Access to Treatments Act of 2017 (HR 2999); Childhood Cancer STAR Act (HR 820/S 292); RxCAP Act of 2017 (S 1347); the FAIR Care Act (S 2494); Patient Advocacy Transparency Act (S. 3000); insurance plan benefit design related to high-cost prescription drugs; Affordable Care Act market stabilization negotiations; pediatric cancer research

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

Sickle Cell Disease Research, Surveillance, Prevention, and Treatment Act of 2017 (H.R. 2410) Sickle Cell Disease Research, Surveillance, Prevention, and Treatment Act of 2018 (S. 2465) Resolution designating September 2018 as "Sickle Cell Disease Awareness Month" (S.Res. 661) Cancer Drug Parity Act (H.R. 1409) Patients Access to Treatment Act (H.R. 2999) Implementation of Patient Protection and Affordable Care Act (P.L. 111-148) Repeal of Patient Protection and Affordable Care Act (P.L. 111-148) Hematology and Oncology Drug Research and Approval Issues Implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) (P.L. 112-144) Clinical Trials Regulations and Coverage Issues Impacting Coverage for Hematologic Diseases and Conditions Reimbursement for CAR-T Issues impacting opioid access/use for patients with hematologic diseases and disorders

Client expense: $30,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

Monitoring healthcare regulations and legislation; Palliative Care Hospice Education and Treatment Act PCHETA (H.R. 1676/S. 693); Oral Cancer Drug Parity Act (H.R. 1409);Title VIII Nursing Workforce Reauthorization Act (H.R. 959; Lymphedema Treatment Act (HR 930, S497); Cancer Communications and Planning Act (HR 5160)

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE

H.R. 1409 Cancer Drug Parity Act; S. 2554/HR. 6143 Patient Right to Know Drug Prices Act; Opioid Monitoring; Drug pricing Monitoring; S. 2680 Opioid Crisis Response Act; H.R.6 Support for Patients and Communities Act.

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

Issues related to blood cancer research, diagnosis, treatment and cures including coverage and reimbursement of cancer treatment therapies and issues related to H. R.1409 the Cancer Drug Parity Act of 2017. Issues related to patient protections for blood cancer patients. Issues related to insurance market stabilization. Issues related to pediatric cancer, including H. R. 820, the Childhood Cancer STAR Act, and it's Senate companion S.292, the Childhood Cancer Survivorship, Treatment Access, and Research Act of 2018. Issues related to Health Savings Accounts. Issues related to Short-Term Limited Duration health insurance plans.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1409, Cancer Drug Coverage Parity Act

Client expense: Not reported · Firm income: $30,000

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE

H.R. 1409 The Cancer Drug Parity Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Regulatory and reimbursement policy issues related to federal healthcare programs, including Medicare and Medicaid. Medicare reimbursement for transformative therapies. H.R. 1409, the "Cancer Drug Parity Act". H.R. 2051, the "FAST Generics Act". H.R. 2077, the "Restoring the Patient's Voice Act". H.R. 6157, "Department of Defense and Labor, Health and Human Services, and Education Appropriations Act". H.R. 6, "SUPPORT for Patients and Communities Act".

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.1409, Cancer Drug Parity Act of 2017, advocate for equitable coverage of cancer therapies; H.R.2999, Patients Access to Treatment Act, advocate for access to cancer therapies; H.R.4978, Chronic Disease Management Act of 2018.

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

Affordable Care Act (ACA); ACA Regulations; Opioid Epidemic; ACA Stabilization; Health Savings Accounts (HSAs); Postal Reform; Cost Sharing Reductions (CSRs); Health Care Reform Reinsurance; Market Stability; State Flexibility; Pay-fors; Affordability; 1332 Templates; Healthcare Innovation; Risk Adjustment; Department Reform; Drug Pricing; Association Health Plans; Short Term Limited Duration; Air Ambulances; 42 CFR Part 2; Individual Market Reform; CREATES Act; Marketplace Certainty Act; Individual Market Rules; Small Group Market; Rural Health; Health Information Technology HR 246 Introduced January 4, 2017 by Kristi Noem (R-SD) This bill repeals a provision of the Patient Protection and Affordable Care Act that imposes an annual fee on a health insurance provider based on its net premium income. HR 314 Introduced January 5, 2017 by Marsha Blackburn (R-TN) To repeal Title I of the Patient Protection and Affordable Care Act and to amend the Public Health Service Act to provide for cooperative governing of individual health insurance coverage offered in interstate commerce. HR 1703 Introduced March 23, 2017 by Morgan Griffith (R-VA) To amend the Federal Food, Drug, and Cosmetic Act with respect to determining the intended use of drugs and devices. HR 2051 FAST Generics Act Introduced April 6, 2017 by David McKinley (R-WV) To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. HR 2430 Introduced May 10, 2017 by Greg Walden (R-OR) To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes. HR 2026 Pharmaceutical Information Exchange Act Introduced April 6, 2017 by Brett Guthrie (R-VA) To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers. HR 1101 Small Business Health Fairness Act of 2017 Introduced February 16, 2017 by Sam Johnson (R-TX) To amend Title I of the Employee Retirement Income Security Act of 1974 to improve access and choice for entrepreneurs with small businesses with respect to medical care for their employees. HR 2400 Introduced May 8, 2017 by Darrell Issa (R-CA) To amend Title 5, United States Code, to allow individuals who are not Federal employees to enroll in the Federal Employees Health Benefits Program, and for other purposes. HR 708 Introduced January 27, 2017 by Larry Bucshon (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 a factor of five, or to a factor determined by the state. This applies to plan years starting on or after January 1, 2018. HR 2051 Fast Generics Act of 2017 Introduced April 6, 2017 by David McKinley (R-VA) To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. HR 2889 Closing Loopholes for Orphan Drugs Act Introduced June 13, 2017 by Peter Welch (D-VT) To amend Title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title. HR 2212 CREATES Act Introduced April 27, 2017 by Tom Marino (R-PA) To promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. HR 1409 Cancer Drug Parity Act of 2017 Introduced by Leonard Lance (R-NJ) To amend the Public Health Service Act to require group and individual health insurance coverage and group health plans to provide for cost-sharing for oral anticancer drugs on terms no less favorable than the cost-sharing provided for anticancer medications administered by a health care provider. HR 749 Lower Drug Cost Through Competition Act Introduced January 30, 2017 by Kurt Schrader (D-OR) To increase competition in the pharmaceutical industry. HR 4666 Premium Relief Act Introduced December 18, 2017 by Ryan Costello (R-PA) To amend the Public Health Service Act to provide for a Patient and State Stability Fund. HR 3976 Access to Marketplace Insurance Act Introduced October 5, 2017 by Kevin Cramer (R-ND) To amend the Patient Protection and Affordable Care Act to allow for certain third-party payments. 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 5228 SCREEN Act Introduced March 8, 2018 by Frank Pallone, Jr. (D-NJ) H.R. 5228 will provide the Food and Drug Administration (FDA) with stronger recall and seizure authority to disrupt the entry of counterfeit and illicit drugs through International Mail Facilities (IMFs). HR 5752 Stop Illicit Drug Importation Act of 2018 Introduced May 10, 2018 by Marsha Blackburn (R-TN) amends the Federal Food, Drug, and Cosmetic Act (FD&C) to strengthen the Food and Drug Administration's (FDA) seizure powers and enhance its authority to detain, refuse, seize, or destroy illegal products offered for import. The legislation would subject more people to debarment and civil penalties under the Act. HR 5806 21st Century Tools for Pain and Addiction Treatment Act Introduced May 15, 2018 by Michael Burgess (R-TX) To require the Secretary of Health and Human Services to issue guidance with respect to the expedited approval of certain drugs, and for other purposes. HR 4998 Health Insurance for Former Foster Youth Act Introduced February 13, 2018 by Karen Bass (D-CA) To amend Title XIX of the Social Security Act to ensure health insurance coverage continuity for former foster youth. HR 5801 Medicaid Providers Are Required To Note Experiences in Record Systems to Help In-need Patients Act Introduced May 15, 2018 by Morgan Griffith (R-VA) To amend Title XIX of the Social Security Act to provide for requirements under the Medicaid program relating to the use of qualified prescription drug monitoring programs and prescribing certain controlled substances. HR 5715 Strengthening Partnerships to Avoid Opioid Abuse Act Introduced May 9, 2018 by James Renacci (R-OH) To amend Title XVIII of the Social Security Act to provide for certain program integrity transparency measures under Medicare Parts C and D. HR 5716 COMPASS Act Introduced May 9, 2018 by Peter Roskam (R-IL) To amend Title XVIII of the Social Security Act to provide for certain program integrity transparency measures under Medicare Parts C and D. HR 5796 Responsible Education Achieves Care and Healthy Outcomes for Users' Treatment Act of 2018 Introduced May 15, 2018 by Brian Fitzpatrick (R-PA) To require the Secretary of Health and Human Services to provide grants for eligible entities to provide technical assistance to outlier prescribers of opioids, and for other purposes. HR 5590 Opioid Addiction Action Plan Act Introduced April 24, 2018 by Adam Kinzinger (R-IL) To require the Secretary of Health and Human Services to provide for an action plan on recommendations for changes under Medicare and Medicaid to prevent opioids addictions and enhance access to medication-assisted treatment, and for other purposes. HR 5603 Access to Telehealth Services for Substance Use Disorders Act Introduced April 24, 2018 by Doris Matsui (D-CA) To amend Title XVIIII of the Social Security Act to provide the Secretary of Health and Human Services authority to waive certain Medicare telehealth requirements in the case of certain treatment of an opioid use disorder or co-occurring mental health disorder. HR 5605 Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act Introduced April 24, 2018 by Raul Ruiz (D-CA) establishes a four-year demonstration program to increase access to treatment for opioid use disorder. The demonstration would provide incentive payments and funding for care management services based on criteria such as patient engagement, use of evidence-based treatments, and treatment length and intensity. Under the bill, the Secretary of Health and Human Services would be directed to encourage other payers to coordinate payments for opioid use disorder treatments and to evaluate the extend to which the demonstration reduces hospitalizations, increases the use of medication-assisted treatments, and improves the health outcomes of individuals with opioid use disorders during and after the demonstration. This bill also incorporates H.R. 3528, Every Prescription Conveyed Securely Act, which would require e-prescribing, with exceptions, for coverage of prescribed controlled substances under the Medicare Part D program. HR 5798 Opioid Screening and Chronic Pain Management Alternatives for Seniors Act Introduced May 15, 2018 by Larry Bucshon (R-IN) To amend Title XVIII of the Social Security Act to require a review of current opioid prescriptions for chronic pain and screening for opioid use disorder to be included in the Welcome to Medicare initial preventive physical examinations. HR 4684 Ensuring Access to Quality Sober Living Act of 2018 Introduced December 19, 2017 by Judy Chu (D-CA) Authorizes the Substance Abuse and Mental Health Services Administration to develop, publish, and disseminate best practices for operating recovery housing that promotes a safe environment and sustained recovery from substance use disorders. Recovery housing is increasingly recognized as critical to recovery for many individuals, and includes activities and programs such as mediation, one-on-one counseling, group sessions, peer recovery support, medication management, spiritual engagement, and others. HR 5329 Poison Center Network Enhancement Act of 2018 Introduced March 19, 2018 by Susan Brooks (D-IN) reauthorizes the national network of Poison Control Centers. Specifically, the legislation reauthorizes the toll-free number, national media campaign, and grant program under the Public Health Service Act. The legislation increases the share of poison control center funding that could be provided through federal grants, and authorizes $30 million per year over the 2019-2023 period. HR 5580 STOP Fentanyl Deaths Act of 2018 Introduced April 23, 2018 by Ann Kuster (D-NH) To authorize the Secretary of Health and Human Services to conduct programs to address the usage of illicit drugs, particularly fentanyl, and for other purposes. HR 5587 Peer Support Communities of Recovery Act Introduced April 23, 2018 by Ben Lujan (D-NM) enhances the Comprehensive Addiction and Recovery Act's Building Communities of Recovery Program and authorizes the Department of Health and Human Services (HHS) to award grants to peer support specialist organizations for the development and expansion of recovery services. Grants shall be awarded to nonprofit organizations that support community-based, peer delivered support, including technical support for the establishment of recovery community organizations, independent, nonprofit groups led by people in recovery and their families. HR 5804 Post-Surgical Injections as an Opioid Alternative Act Introduced May 15, 2018 by John Shimkus (R-IL) To amend Title XVIII of the Social Security Act to provide for modifications in payment for certain outpatient surgical services. HR 5809 Postoperative Opioid Prevention Act of 2018 Introduced May 15, 2018 by Scott Peters (D-CA) To amend Title XVIII of the Social Security Act to encourage the use of non-opioid analgesics for the management of post-surgical pain under the Medicare program, and for other purposes. HR 5795 Overdose Prevention and Patient Safety Act Introduced May 15, 2018 by Earl Blumenauer (D-OR) To amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records. HR 5812 Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 Introduced May 15, 2018 by Morgan Griffith (R-VA) Will authorize the Centers for Disease Control and Prevention to carry out certain controlled substances overdose prevention and surveillance activities in order to improve data collection and integration into physician clinical workflow so that timely, complete, and accurate information will get into the hands of providers and dispensers so that they can make the best clinical decisions for their patients. HR 449 Synthetic Drug Awareness Act of 2018 Introduced January 11, 2017 by Hakeem Jeffries (D-NY) requires the U.S. Surgeon General to report to Congress on the public health effects of the rise in synthetic drug use among youth aged 12 to 18 years old in order to further educate parents and the medical community on the health effects of synthetics. HR 4284 INFO Act Introduced November 7, 2017 by Robert Latta (R-OH) directs the Department of Health and Human Services (HHS) to create a public and easily accessible electronic dashboard linking to all of the nationwide efforts to combat the opioid crisis. In addition, the legislation creates an Interagency Substance Use Disorder Coordinating Committee to review and coordinate opioid use disorder (OUD) and other substance use disorder (SUD) research, services, and prevention activities across all relevant Federal agencies, evaluate the effectiveness of these activities, and make specific recommendations for actions that agencies can take to better coordinate the administration of services for patients with OUD and SUD. HR 5002 Advancing Cutting Edge Research Act Introduced February 18, 2018 by Debbie Dingell (D-MI) Provides the National Institutes of Health new authorities to conduct research on innovative non-addictive pain medications. HR 5102 Substance Use Disorder Workforce Loan Repayment Act of 2018 Introduced February 27, 2018 by Katherine Clark (D-MA) creates a loan repayment program for substance use disorder (SUD) treatment providers. Specifically, the legislation offers student loan repayment of up to $250,000 for participants who agree to work as a SUD treatment professional in areas most in need of their services. The program is available to a wide range of direct care providers, including physicians, registered nurses, social workers, and other behavioral health professionals. The bill authorizes $25 million a year for the 2019-2028 period. HR 5009 Jessie's Law Introduced February 13, 2018 by Tim Walberg (R-MI) Ensures medical professionals have access to a consenting patient's complete health information when making treatment decisions by requirement the Department of Health and Human Services (HHS) to develop and annually disseminate best practices regarding the prominent display of substance use disorder (SUD) history in records of patients who have previously provided this information to a health care provider. HR 5176 Preventing Overdoses While in Emergency Room Act of 2018 Introduced March 6, 2018 by David McKinley (R-VA) requires the Secretary of the Department of Health and Human Services (HHS) to develop protocols and a grant program for health care providers to address the needs of people who survive a drug overdose. Specifically, the protocols would address the provision of naloxone upon discharge, connection with peer-support specialists, and the referral to treatment and other services that best fit the patient's needs. The bill authorizes $50 million in FY 2019 for the grant program. HR 5197 ALTO Act Introduced March 7, 2018 by Bill Pascrell, Jr. (D-NJ) Directs the Secretary of Health and Human Services (HHS) to carry out a demonstration program to test alternative pain management protocols to limit the use of opioids in hospital emergency departments. Following the completion of the three-year demonstration, the Secretary of Health and Human Services will submit a report to Congress on the results of the program and issue recommendations for broader implementation. The legislation authorizes $10 million annually in grants for fiscal years 2019-2021.

Client expense: $10,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2051, "FAST Generics Act of 2017", provisions regarding REMS. H.R. 1409, "Cancer Drug Parity Act of 2017", regarding all provisions. H.R. 2077, "Restoring the Patient's Voice Act of 2017", Step Therapy / Fail First. S. 974/ H.R. 2212, "CREATES Act of 2017", provisions regarding REMS. Issues relating to Cancer Drug Coverage Parity. Issues relating to Step Therapy / Fail First. Issues relating to Medicare Part D / Part B. Issues relating to Medicare Reimbursement for Transformative Therapies.

Client expense: $670,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Affordable Care Act (ACA); ACA Regulations; Opioid Epidemic; ACA Stabilization; Health Savings Accounts (HSAs); Postal Reform; Cost Sharing Reductions (CSRs); Health Care Reform Reinsurance; Market Stability; State Flexibility; Pay-fors; Affordability; 1332 Templates; Healthcare Innovation; Risk Adjustment; Department Reform; Drug Pricing; Association Health Plans; Short Term Limited Duration; Air Ambulances; 42 CFR Part 2; Individual Market Reform; CREATES Act; Marketplace Certainty Act; Individual Market Rules; Small Group Market; Rural Health; Health Information Technology HR 246 Introduced January 4, 2017 by Kristi Noem (R-SD) This bill repeals a provision of the Patient Protection and Affordable Care Act that imposes an annual fee on health insurance provider based on its net premium income. HR 314 Introduced January 5, 2017 by Marsha Blackburn (R-TN) to repeal title I of the Patient Protection and Affordable Care Act and to amend the Public Health Service Act to provide for cooperative governing of individual health insurance coverage offered in interstate commerce. HR 2051 FAST Generics Act Introduced April 6, 2017 by David McKinley (R-WV) to amend the Federal Food, Drug and Cosmetic Act to ensure eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. HR 2430 Introduced May 10, 2017 by Greg Walden (R-OR) to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs and biosimilar biological products and for other purposes. HR 2400 Introduced May 8, 2017 by Darrell Issa (R-CA) to amend title 5, United States Code. To allow individuals who are not Federal employees to enroll in the Federal Employees Health Benefits Program and for other purposes. HR 708 Introduced January 27, 2017 by Larry Buchshon (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 a factor of five, or to a factor determined by the state. This applies to plan years starting on or after January 1, 2018. HR 829 Prioritizing the Most Vulnerable Over Lottery Winners Act of 2017 Introduced February 2, 2017 by Fred Upton (R-MI) This bill amends title XIX (Medicaid) to specify how a state must treat qualified lottery winnings and lump sum income for purposes of determining an individuals income-based eligibility for a state Medicaid program. Specifically, a state shall include such winnings or income as income received: (1) in the month in which it was received, if the amount is less than $80,000; (2) over a period of two months, if the amount is at least $80,000 but less than $90,000; (3) over a period of three months, if the amount is at least $90,000 but less than $100,000; and (4) over an additional one-month period for each increment of $10,000 received, not to exceed 120 months. HR 1082 Medicaid Home Improvement Act Introduced February 15, 2017 by Brett Guthrie (R-KY) to amend title XIX of the Social Security Act to eliminate the State option to reduce the home equity exemption amount for purposes of eligibility for long-term care assistance under Medicaid, and for other purposes. HR 3922 Championing Healthy Kids Act Introduced October 3, 2017 by Greg Walden (R-OR) Extends funding for the Childrens Health Insurance Program (CHIP) through Fiscal Year (FY)2022, Federally Qualified Health Centers (FQHCs) through FY2019 and revises CHIP and Medicaid. HR 2051 Fast Generics Act of 2017 Introduced April 6, 2017 by David McKinley (R-VA) to amend the Federal Food, Drug and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products and for other purposes. HR 2889 Closing Loopholes for Orphan Drugs Act Introduced June 13, 2017 by Peter Welch (D-VT) to amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title. HR 2212 CREATES Act introduced April 27, 2017 by Tom Marino (R-PA) to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. HR 1409 Cancer Drug Parity Act of 2017 Introduced March 7, 2017 by Leonard Lance (R-NJ) to amend the Public Health Service Act to require group and individual health insurance coverage and group health plans to provide for cost sharing for oral anticancer drugs on terms no less favorable than the cost sharing provided for anticancer medications administered by a health care provider. HR 749 Lower Drug Cost Through Competition Act Introduced January 30, 2017 by Kurt Schrder (D-OR) to increase competition in the pharmaceutical industry. HR 4666 Premium Relief Act Introduced December 18, 2017 by Ryan Costello (R-PA) To amend the Public Health Service Act to provide for a Patient and State Stability Fund. HR 3976 Access to Marketplace Insurance Act Introduced October 5, 2017 by Kevin Cramer (R-ND) to amend the Patient Protection and Affordable Care Act to allow for certain third-party payments. 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 Way and Means Committee. HR 5752 Stop Illicit Drug Importation Act of 2018 introduced May 10, 2018 by Marsha Blackburn (R-TN) amends the Federal Food, Drug, and Cosmetic Act (FD&C) to strengthen the Food and Drug Administrations (FDA) seizure powers and enhance its authority to detain, refuse, seize or destroy illegal products offered for import. The legislation would subject more people to debarment and civil penalties under the Act. HR 5806 21st Century Tools for Pain and Addiction Treatment Act Introduced May 15, 2018 by Michael Burgess (R-TX) to require the Secretary of Health and Human Services to issue guidance with respect to the expedited approval of certain, drugs and for other purposes. HR 5811 Long-Term Opioid Efficacy Act of 2018 Introduced May 15, 2018 by Jerry McNerney (D-CA) to amend the Federal Food, Drug, and Cosmetic Act with respect to post approval study requirements for certain controlled substances, and for other purposes. HR 1925 At-Risk Youth Medicaid Protection Act of 2018 Introduced April 5, 2017 by Tony Cardenas (D-CA) to amend title XIX of the Social Security Act to protect at-risk youth against termination of Medicaid eligibility while an inmate of a public institution. HR 3192 CHIP Mental Health Parity Act to amend title XXI of the Social Security Act to ensure access to mental health services for children under the Childrens Health Insurance Program and for other purposes. HR 4005 Medicaid Reentry Act Directs the Secretary of Health and Human Services to convene a group of stakeholders and develop and report to Congress on best practices for addressing issues related to health care faced by those returning from incarceration to their communities. In addition, the legislation allows Medicaid payment for medical services furnished to an incarcerated individual during the 30-day period preceding the individuals release. HR 5789 Introduced May 15, 2018 by Bill Foster (D-IL) to amend title XIX of the Social Security Act to [provide for Medicaid coverage protection for pregnant and post-partum women while receiving inpatient treatment for substance use disorder, and for other purposes. HR 5797 Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act Introduced May 15, 2018 by Mimi Walters (D-CA) Allows state Medicaid programs to remove the Institutions for Mental Diseases (IMD) exclusion for Medicaid beneficiaries aged 21-64 with an opioid use disorder for fiscal years 2019 to 2023. By removing the exclusion, Medicaid would pay for up to 30 total days of care in an IMD during a 12-month period for eligible individuals. Opioid use disorder as defined in H.R. HR 5800 Introduced May 15, 2018 by Fred Upton (R-MI) directs the Medicaid and CHIP Payment and Access Commission (MACPAC) to conduct a study on institutions for mental disease that receive Medicaid reimbursement. The study shall report on the requirements and standards that state Medicaid programs have in place for institutions for mental diseases (IMD). MACPAC shall summarize the findings and make recommendations on best practices and data collection no later than January 2020. HR 5810 Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act Introduced May 15, 2018 by Leonard Lance (R-NJ) to amend title XIX of the Social Security Act to provide for an extension of the enhanced FMAP for certain Medicaid health homes for individuals with substance use disorders. HR 5715 Strengthening Partnerships to Avoid Opioid Abuse Act Introduced May 9, 2018 by James Renacci (R-OH) to amend title XVII of the Social Security Act to provide for certain program integrity transparency measures under Medicare parts C and D. HR 5716 COMPASS Act Introduced May 9, 2018 by Peter Roskam (R-IL) to amend title XVIII of the Social Security Act to provide for certain program integrity transparency measures under Medicare parts C and D. HR 5796 Responsible Education Achieves Care and Healthy Outcomes for Users Treatment Act of 2018 Introduced May 15, 2018 by Brian Fitzpatrick (R-PA) to require the Secretary of Health and Human Services to provide grants for eligible entities to provide technical assistance to outlier prescribers of opioids and for other purposes. HR 5590 Opioid Addiction Action Plan Introduced April 24, 2018 by Adam Kinzinger (R-IL) to require the Secretary of Health and Human Services to provide for an action plan on recommendations for changes under Medicare and Medicaid to prevent opioids addictions and enhance access to medication-assisted treatment and for other purposes. HR 5603 Access to Telehealth Services for Substance Use Disorders Act Introduced April 24, 2018 by Doris Matsui (D-CA) to amend title XVIII of the Social Security Act to provide the Secretary of Health and Human Services Authority to waive certain Medicare telehealth requirements in the case of certain treatment of an opioid use disorder or co-occurring mental health disorder. HR 5605 Advancing Hight Quality Treatment for Opioid Use Disorders in Medicare Act Introduced April 24, 2018 by Raul Ruiz (D-CA) establishes a four-year demonstration program to increase access to treatment for opioid use disorder. The demonstration would provide incentive payments and funding for care management services based on criterial such as patient engagement, use of evidence-based treatments, and treatment length and intensity. Under the bill, the Secretary of Health and Human Services would be directed to encourage other payers to coordinate payments for opioid use disorder treatments and to evaluate the extent to which the demonstration reduces hospitalizations, increases the use of medication-assisted treatments, and improves the health outcomes of individuals with opioid use disorders during and after the demonstration. This bill also incorporates HR 3528 Every Prescription Conveyed Securely Act which would require e-prescribing, with exceptions, for coverage of prescribed controlled substances under the Medicare Part D program. HR 5798 Opioid Screening and Chronic Pain Management Alternatives for Seniors Act Introduced May 15, 2018 by Larry Bucshon (R-IN) to amend title XVII of the Social Security Act to require a review of current opioid prescriptions for chronic pain and screening for opioid use disorder to be included in the Welcome to Medicare initial preventative physical examination. HR 5329 Poison Center Network Enhancement Act of 2018 Introduced March 19, 2018 by Susan Brooks (D-IN) reauthorizes the national network of Poison Control Centers. Specifically, the legislation reauthorizes the toll-free number, national media campaign, and grant program under the Public Health Poison Control Centers. Specifically, the legislation reauthorizes the toll-free number, national media campaign, and grant program under the Public Health Service Act. The Legislation increases the share of poison control center funding that could be provided through federal grants, and authorizes $30 million per year over the 2019-2023 period. HR 5804 Post Surgical Injections as an Opioid Alternative Act Introduced May 15, 2018 by John Shimkus (R-IL) to amend title XVII of the Social Security act to provide for modifications in payment for certain outpatient surgical services. HR 5809 Postoperative Opioid Prevention Act of 2018 Introduced May 15, 2018 by Scott Peters (D-CA) to amend title XVII of the Social Security Act to encourage the use of non-opioid analgesics for the management of post-surgical pain under the Medicare program and for other purposes. HR 5795 Overdose Prevention and Patient Safety Act Introduced May 15, 2018 by Earl Blumenauer (D-OR) to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records. HR 5812 Creating Opportunities that necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 Introduced May 15, 2018 by Morgan Griffith (R-VA) will authorize the Centers for Disease Control and Prevention to carry out certain controlled substances overdose prevention and surveillance activities in order to improve data collection and integration into physician clinical workflow so that timely, complete, and accurate information will get into the hands of providers and dispensers so that they can make the best clinical decisions for their patients. HR 449 Synthetic Drug Awareness act of 2018 Introduced January 11, 2017 by Hakeem Jeffries (D-NY) requires the US Surgeon General to report to Congress on the public health effects of the rise in synthetic drug use among youth aged 12-18 years old in order to further educate parents and the medical community on the health effects of synthetics. HR 4284 INFO Act Introduced November 7, 2017 by Robert Latta (R-OH) directs the Department of Health and Human Services (HHS) to create a public and easily accessible electronic dashboard linking to all of the nationwide efforts to combat the opioid crisis. In addition, the legislation creates an Interagency Substance Use Disorder Coordinating Committee to review and coordinate opioid use disorder (OUD) and other substance use disorder (SUD) research, services, and prevention activities across relevant Federal agencies, evaluate the effectiveness of these activities and make specific recommendations for actions that the agencies can take to better coordinates the administration of services for patients with OUD and SUD. HR 5002 Advancing Cutting-Edge Research Act Introduced February 18, 2018 by Debbie Dingell (D-MI) Provides the National Institutes of Health ne authorities to conduct research on innovative and non-addictive pain medications. HR 5102 Substance Use Disorder Workforce Loan Repayment Act of 2018 Introduced February 27, 2018 by Katherine Clark (D-MA) creates a loan repayment program for substance use disorder (SUD) treatment providers. Specifically, the legislation offers student loan repayment up to $250,000 for participants who agree to work as an SUD professional in areas most in need of their services. The program is available to a wide range of direct care providers, including physicians, registered nurses, social workers, and other behavioral health professionals. The bill authorizes $25 million a year for the 2019-2028 period. HR 5009 Jessies Law Introduced February 13, 2018 by Tim Walberg (R-MI) Ensures medical professionals have access to a consenting patients complete health information when making treatment decisions by requiring the Department of Health and Human Services (HHS) to develop and annually disseminate best practices regarding the prominent display of substance use disorder (SUD) history in records of patients who have previously provided this information to a health care provider. HR 5176 Preventing Overdoses While in Emergency Rooms Act of 2018 Introduced March 6, 2018 by David McKinley (R-VA) requires the Secretary of the Department of Health and Human Services (HHS) to develop protocols and a grant program for health care providers to address the needs of people who survive a drug overdose. Specifically, the protocols would address the provision of naloxone upon discharge, connection with peer-support specialists, and the referral to treatment and other services that best fit the patients needs. The bill authorizes $50 million in FY 2019 for the grant program.

Client expense: $89,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FY19 Appropriations for NIH, CDC, and DoD ovarian cancer programs. Supporting H.R.1409 - Cancer Drug Parity Act of 2017. Supporting the re-authorization of Johanna's Law.

Client expense: Not reported · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, SENATE

H.R.1409 - Cancer Drug Parity Act of 2017 H.R.820/ S. 292 - Childhood Cancer STAR Act H.R.1231/S. 456 - RACE for Children Act H.R.1676/S. 693 - Palliative Care and Hospice Education and Training Act H.R.878 - Right to Try Act of 2017 S.204 - Trickett Wendler Right to Try Act of 2017 H.R.1854/ S. 778 - Prescription Drug Monitoring Act of 2017 Diagnostic Accuracy and Innovation Act (DAIA)(Draft legislation) H.R. 2430 FDA Reauthorization Act S. 934 FDA Reauthorization Act H.R. 2797/ S.1334Patient Choice and Quality Care Act (PCQCA) H.R. 2999Patient's Access to Treatment Act (PATA) H.R. 1628Better Care Reconciliation Act (BCRA) H.R. 1316Prescription Drug Pricing Transparency Act H.R. 2077 Restoring Patients Voices Act

Client expense: $62,560 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Affordable Care Act (ACA); ACA Regulations; ACA Stabilization; Health Savings Accounts (HSA); Small Group Market Reform; Short Term Limited Duration (STLD); Cost-sharing Reduction (CSR); Reinsurance; Risk Adjustment; Market Stability; Drug Pricing; Individual Market Reform; CREATES ACT; Health Insurance Tax (HIT); Affordability; Individual Market Rules; Small Group Market; Postal Reform; Association of Health Plans Opioid Epidemic; State Flexibility; Pay-fors; 42 CFR Part 2. HR 246 Introduced January 4, 2017 by Kristi Noem (R-SD) This bill repeals a provision of the Patient Protection and Affordable Care Act that imposes an annual fee on a health insurance provider based on its net premium income. HR 314 Introduced January 5, 2017 by Marsha Blackburn (R-TN) To repeal title I of the Patient Protection and Affordable Care Act and to amend the Public Health Service Act to provide for cooperative governing of individual health insurance coverage offered in interstate commerce. HR 1703 Introduced March 23, 2017 by Morgan Griffith (R-VA) To amend the Federal Food, Drug, and Cosmetic Act with respect to determining the intended use of drugs and devices. HR 2051 FAST Generics Act Introduced April 6, 2017 by David McKinley (R-WV) To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. HR 2430 Introduced May 10, 2017 by Greg Walden (R-OR) To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes. HR 1101 Small Business Health Fairness Act of 2017 Introduced February 16, 2017 by Sam Johnson (R-TX) To amend title I of the Employee Retirement Income Security Act of 1974 to improve access and choice for entrepreneurs with small businesses with respect to medical care for their employees. HR 708 Introduced January 27, 2017 by Larry Bucshon (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 a factor of five, or to a factor determined by the state. This applies to plan years starting on or after January 1, 2018. HR 3922 Championing Healthy Kids Act Introduced October 3, 2017 by Greg Walden (R-OR) Extends funding for the Childrens Health Insurance Program (CHIP) through Fiscal Year (FY) 2022, Federally Qualified Health Centers (FQHCs) through FY2019, and revises CHIP and Medicaid. HR 2212 CREATES Act Introduced April 27, 2017 by Tom Marino (R-PA) To promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. HR 1409 Cancer Drug Parity Act of 2017 Introduced March 7, 2017 by Leonard Lance (R-NJ) To amend the Public Health Service Act to require group and individual health insurance coverage and group health plans to provide for cost sharing for oral anticancer drugs on terms no less favorable than the cost sharing provided for anticancer medications administered by a health care provider. HR 749 Lower Drug Cost Through Competition Act Introduced January 30, 2017 by Kurt Schrader (D-OR) To increase competition in the pharmaceutical industry. HR 4666 Premium Relief Act Introduced December 18, 2017 by Ryan Costello (R-PA) To amend the Public Health Service Act to provide for a Patient and State Stability Fund. HR 3976 Access to Marketplace Insurance Act Introduced October 5, 2017 by Kevin Cramer (R-ND) To amend the Patient Protection and Affordable Care Act to allow for certain third-party payments. 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 5806 21st Century Tools for Pain and Addiction Treatment Act Introduced May 15, 2018 by Michael Burgess(R-TX) To require the Secretary of Health and Human Services to issue guidance with respect to the expedited approval of certain drugs, and for other purposes. HR 5808 Medicaid Pharmaceutical Home Act of 2018 Introduced May 15, 2018 by Gus Bilirakis (R-FL) To amend title XIX of the Social Security Act to require States to operate drug management programs for at-risk beneficiaries, and for other purposes. HR 5810 Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act Introduced May 15, 2018 by Leonard Lance (R-NJ) To amend title XIX of the Social Security Act to provide for an extension of the enhanced FMAP for certain Medicaid health homes for individuals with substance use disorders. HR 5796 Responsible Education Achieves Care and Healthy Outcomes for Users Treatment Act of 2018 Introduced May 15, 2018 by Brian Fitzpatrick (R-PA) To require the Secretary of Health and Human Services to provide grants for eligible entities to provide technical assistance to outlier prescribers of opioids, and for other purposes. HR 5590 Opioid Addiction Action Plan Act Introduced April 24, 2018 by Adam Kinzinger (R-IL) To require the Secretary of Health and Human Services to provide for an action plan on recommendations for changes under Medicare and Medicaid to prevent opioids addictions and enhance access to medication-assisted treatment, and for other purposes. HR 4684 Ensuring Access to Quality Sober Living Act of 2018 Introduced December 19, 2017 by Judy Chu (D-CA) Authorizes the Substance Abuse and Mental Health Services Administration to develop, publish, and disseminate best practices for operating recovery housing that promotes a safe environment and sustained recovery from substance use disorders. Recovery housing is increasingly recognized as critical to recovery for many individuals, and includes activities and programs such as mediation, one-on one counseling, group sessions, peer recovery support, medication management, spiritual engagement, and others. HR 5580 STOP Fentanyl Deaths Act of 2018 Introduced April 23, 2018 by Ann Kuster (D-NH) To authorize the Secretary of Health and Human Services to conduct programs to address the usage of illicit drugs, particularly fentanyl, and for other purposes. HR 5587 Peer Support Communities of Recovery Act Introduced April 23, 2018 by Ben Lujan (D-NM) enhances the Comprehensive Addiction and Recovery Acts Building Communities of Recovery Program and authorizes the Department of Health and Human Services (HHS) to award grants to peer support specialist organizations for the development and expansion of recovery services. Grants shall be awarded to nonprofit organizations that support community-based, peer delivered support, including technical support for the establishment of recovery community organizations, independent, nonprofit groups led by people in recovery and their families. HR 5795 Overdose Prevention and Patient Safety Act Introduced May 15, 2018 by Earl Blumenauer (D-OR) To amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records. HR 5812 Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 Introduced May 15, 2018 by Morgan Griffith (R-VA) Will authorize the Centers for Disease Control and Prevention to carry out certain controlled substances overdose prevention and surveillance activities in order to improve data collection and integration into physician clinical workflow so that timely, complete, and accurate information will get into the hands of providers and dispensers so that they can make the best clinical decisions for their patients. HR 4284 INFO Act Introduced November 7, 2017 by Robert Latta (R-OH) directs the Department of Health and Human Services (HHS) to create a public and easily accessible electronic dashboard linking to all of the nationwide efforts to combat the opioid crisis. In addition, the legislation creates an Interagency Substance Use Disorder Coordinating Committee to review and coordinate opioid use disorder (OUD) and other substance use disorder (SUD) research, services, and prevention activities across all relevant Federal agencies, evaluate the effectiveness of these activities, and make specific recommendations for actions that agencies can take to better coordinates the administration of services for patients with OUD and SUD. HR 5009 Jessies Law Introduced February 13, 2018 by Tim Walberg (R-MI) Ensures medical professionals have access to a consenting patients complete health information when making treatment decisions by requiring the Department of Health and Human Services (HHS) to develop and annually disseminate best practices regarding the prominent display of substance use disorder (SUD) history in records of patients who have previously provided this information to a health care provider. HR 5197 ALTO Act Introduced March 7, 2018 by Bill Pascrell, Jr. (D-NJ) Directs the Secretary of Health and Human Services (HHS) to carry out a demonstration program to test alternative pain management protocols to limit the use of opioids in hospital emergency departments. Following the completion of the three-year demonstration, the Secretary of Health and Human Services will submit a report to Congress on the results of the program and issue recommendations for broader implementation. The legislation authorizes $10 million annually in grants for fiscal years 2019-2021.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Affordable Care Act (ACA) Regulations; Opioid Epidemic; ACA Stabilization; Health Savings Accounts (HSAs); Cost Sharing Reductions (CSRs); Reinsurance; Market Stability; State Flexibility; Affordability; Risk Adjustment; Drug Pricing; Association Health Plans (AHPs); State 1332 Waivers; Small Group Market; Short Term Limited Duration Insurance (STLDI); Individual Market Rules HR 246 Introduced January 4, 2017 by Kristi Noem (R-SD). This bill repeals a provision of the ACA that imposes an annual fee on a health insurance provider based on its net premium income. HR 314 Introduced January 5, 2017 by Marsha Blackburn (R-TN). To repeal title I of the ACA and to amend the Public Health Service Act (PHSA) to provide for cooperative governing of individual health insurance coverage offered in interstate commerce. HR 2051 Introduced April 6, 2017 by David McKinley (R-WV). The FAST Generics Act amends the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. HR 2430 Introduced May 10, 2017 by Greg Walden (R-OR). To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes. HR 1101 Introduced February 16, 2017 by Sam Johnson (R-TX). The Small Business Health Fairness Act of 2017 amends title I of the Employee Retirement Income Security Act of 1974 to improve access and choice for entrepreneurs with small businesses with respect to medical care for their employees. HR 708 Introduced January 27,2017 by Larry Bucshon (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 a factor of five, or a factor determined by the state. HR 3922 Introduced October 3, 2017 by Greg Walden (R-OR). The Championing Healthy Kids Act extends funding for the Childrens Health Insurance Program (CHIP) through fiscal year (FY) 2022, Federally Qualified Health Centers (FQHCs) through FY 2019, and revises CHIP and Medicaid. HR 2889 Introduced June 13, 2017 by Peter Welch (D-VT). The Closing Loopholes for Orphan Drugs Act amends title III of the PHSA to limit the orphan drug exclusion under the drug discount program under section 340B of such title. HR 2212 Introduced April 27, 2017 by Tom Marino (R-PA). The CREATES Act promotes competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. HR 1409 Introduced March 7, 2017 by Leonard Lance (R-NJ). The Cancer Drug Parity Act of 2017 amends the PHSA to require group and individual health insurance coverage and group health plans to provide for cost sharing for oral anticancer drugs on terms no less favorable than the cost sharing provided for anticancer medications administered by a health care provider. HR 4666 Introduced December 18, 2017 by Ryan Costello (R-PA). The Premium Relief Act amends the PHSA to provide for a Patient State and Stability Fund. HR 3976 Introduced October 5, 2017 by Kevin Cramer (R-ND). The Access to Marketplace Insurance Act amends the ACA to allow for certain third-party payments. 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 5806 Introduced May 15, 2018 by Michael Burgess (R-TX). The 21st Century Tools for Pain and Addiction Treatment Act requires the Secretary of Health and Human Services to issue guidance with respect to the expedited approval of certain drugs, and for other purposes. HR 5811 Introduced May 15, 2018 by Jerry McNerney (D-CA). The Long-Term Opioid Efficacy Act of 2018 amends the Federal Food, Drug, and Cosmetic Act with respect to postapproval study requirements for certain controlled substances, and for other purposes. HR 3192 Introduced July 12, 2017 by Joseph Kennedy (D-MA). The CHIP Mental Health Parity Act amends title XXI of the Social Security Act to ensure access to mental health services for children under CHIP, and for other purposes. HR 5715 Introduced May 9, 2018 by James Renacci (R-OH). The Strengthening Partnerships to Avoid Opioid Abuse Act amends title XVIII of the Social Security Act to provide for certain program integrity transparency measures under Medicare Parts C and D. HR 5590 Introduced April 24, 2018 by Adam Kinzinger (R-IL). The Opioid Addiction Action Plan requires the Secretary of Health and Human Services to provide for an action plan on recommendations for changes under the Medicare and Medicaid programs to prevent opioid addiction and enhance access to medication assisted treatment, and for other purposes. HR 5603 Introduced April 24, 2018 by Doris Matsui (D-CA). The Access to Telehealth Services for Substance Use Disorders Act amends title XVIII of the Social Security Act to provide the Secretary of Health and Human Services authority to waive certain Medicare telehealth requirements in the case of certain treatment of an opioid use disorder or a co-occurring mental health disorder. HR 5580 Introduced April 23, 2018 by Ann Kuster (D-NH). The STOP Fentanyl Deaths Act of 2018 authorizes the Secretary of Health and Human Services to conduct programs to address the usage of illicit drugs, particularly fentanyl, and for other purposes. HR 5809 Introduced May 15, 2018 by Scott Peters (D-CA). The Postoperative Opioid Prevention Act of 2018 amends title XVIII of the Social Security Act to encourage the use of non-opioid analgesics for the management of post-surgical pain under the Medicare program, and for other purposes. HR 5795 Introduced May 15, 2018 by Earl Blumenauer (D-OR). The Overdose Prevention and Patient Safety Act amends the PHSA to protect the confidentiality of substance use disorder patient records. HR 5009 Introduced February 13, 2018 by Tim Walberg (R-MI). Jessies Law ensures medical professionals have access to a consenting patients complete health information when making treatment decisions by requiring the Department of Health and Human Services to develop and annually disseminate best practices regarding the prominent display of substance use disorder (SUD) history in records of patients who have previously provided this information to a health care provider.

Client expense: $410,000 · 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

Cancer Drug Parity Act (HR 1409); the Right to Try Act (S 204, HR 878); the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 (HR 5247); Patients' Access to Treatments Act of 2017 (HR 2999); Childhood Cancer STAR Act (HR 820/S 292); RxCAP Act of 2017 (S 1347); the FAIR Care Act (S 2494); Patient Advocacy Transparency Act (S. 3000); insurance plan benefit design related to high-cost prescription drugs; Affordable Care Act market stabilization negotiations; pediatric cancer research

Client expense: $180,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

S. 2852, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018; H.R. 4710, 340B PAUSE Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; S. 204, H.R. 878, Trickett Wendler Right to Try Act of 2017; H.R. 5247, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018; H.R. 2077, Restoring the Patient's Voice Act of 2017; H.R. 1409, Cancer Drug Parity Act; S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; S. 1681, A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services; Proposals related to drug pricing; S. 1347, RxCAP Act of 2017; 42 USC 1320a-7b, Anti-Kickback Statute; H.R. 5867, H.R. 6142, Reducing Drug Waste Act of 2018; Discussions related to mental health/depression in the opioid epidemic;

Client expense: $840,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Sickle Cell Disease Research, Surveillance, Prevention, and Treatment Act of 2017 (H.R. 2410) Sickle Cell Disease Research, Surveillance, Prevention, and Treatment Act of 2018 (S. 2465) Cancer Drug Parity Act (H.R. 1409) Patients Access to Treatment Act (H.R. 2999) Implementation of Patient Protection and Affordable Care Act (P.L. 111-148) Repeal of Patient Protection and Affordable Care Act (P.L. 111-148) Hematology and Oncology Drug Research and Approval Issues Implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) (P.L. 112-144) Clinical Trials Regulations and Coverage Issues Impacting Coverage for Hematologic Diseases and Conditions Reimbursement for CAR-T Issues impacting opioid access/use for patients with hematologic diseases and disorders

Client expense: $30,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

Affordable Care Act (ACA); ACA Regulations; Opioid Epidemic; ACA Stabilization;; Health Savings Accounts (HSAs); Postal Reform; Cost Sharing Reductions (CSRs); Health Care Reform Reinsurance; Market Stability; State Flexibility; Pay-fors; Affordability; 1332 Templates; Healthcare Innovation; Risk Adjustment; Department Reform; Drug Pricing; Association Health Plans; Short Term Limited Duration; Air Ambulances; 42 CFR Part 2; Individual Market Reform; CREATES Act; Marketplace Certainty Act; Individual Market Rules; Small Group Market; Rural health; Health Information Technology HR 246 Introduced January 4, 2017 by Kristi Noem (R-SD) This bill repeals a provision of the Patient Protection and Affordable Care Act that imposes an annual fee on a health insurance provider based on its net premium income. HR 314 Introduced January 5, 2017 by Marsha Blackburn (R-TN) To repeal title I of the Patient Protection and Affordable Care Act and to amend the Public Health Service Act to provide for cooperative governing of individual health insurance coverage offered in interstate commerce. HR 1703 Introduced March 23, 2017 by Morgan Griffith (R-VA) To amend the Federal Food, Drug, and Cosmetic Act with respect to determining the intended use of drugs and devices. HR 2051 FAST Generics Act Introduced April 6, 2017 by David McKinley (R-WV) To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. HR 2430 Introduced May 10, 2017 by Greg Walden (R-OR) To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes. HR 2026 Pharmaceutical Information Exchange Act Introduced April 6, 2017 by Brett Guthrie (R-VA) To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers. HR 1101 Small Business Health Fairness Act of 2017 Introduced February 16, 2017 by Sam Johnson (R-TX) To amend title I of the Employee Retirement Income Security Act of 1974 to improve access and choice for entrepreneurs with small businesses with respect to medical care for their employees. HR 2400 Introduced May 8, 2017 by Darrell Issa (R-CA) To amend title 5, United States Code, to allow individuals who are not Federal employees to enroll in the Federal Employees Health Benefits Program, and for other purposes. HR 180 To amend title XIX of the Social Security Act to eliminate the requirement for 3 months of retroactive coverage under the Medicaid program Introduced January 3, 2017 by Markwayne Mullin (R-OK) Under current law, a state Medicaid program must provide coverage for up to three months prior to an individual's application for benefits if the individual would have been eligible for benefits during that period. The bill eliminates this requirement and instead specifies that coverage begins in the month during which the individual applies for benefits. HR 708 Introduced January 27, 2017 by Larry Bucshon (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 a factor of five, or to a factor determined by the state. This applies to plan years starting on or after January 1, 2018. HR 829 Prioritizing the Most Vulnerable Over Lottery Winners Act of 2017 Introduced February 2, 2017 by Fed Upton (R-MI) This bill amends title XIX (Medicaid) to specify how a state must treat qualified lottery winnings and lump sum income for purposes of determining an individual's income-based eligibility for a state Medicaid program. Specifically, a state shall include such winnings or income as income received: (1) in the month in which it was received, if the amount is less than $80,000; (2) over a period of two months, if the amount is at least $80,000 but less than $90,000; (3) over a period of three months, if the amount is at least $90,000 but less than $100,000; and (4) over an additional one-month period for each increment of $10,000 received, not to exceed 120 months. HR 1082 Medicaid Home Improvement Act Introduced February 15, 2017 by Brett Guthrie (R-KY) To amend title XIX of the Social Security Act to eliminate the State option to reduce the home equity exemption amount for purposes of eligibility for long-term care assistance under Medicaid, and for other purposes. HR 1150 Tanning Tax Repeal of 2017 Introduced February 16, 2017 by George Holding (R-NC) To amend the Internal Revenue Code of 1986 to repeal the excise tax on indoor tanning services. HR 3922 Championing Healthy Kids Act Introduced October 3, 2017 by Greg Walden (R-OR) Extends funding for the Childrens Health Insurance Program (CHIP) through Fiscal Year (FY) 2022, Federally Qualified Health Centers (FQHCs) through FY2019, and revises CHIP and Medicaid. HR 2051 Fast Generics Act of 2017 Introduced April 6, 2017 by David McKinley (R-VA) To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. HR 2889 Closing Loopholes for Orphan Drugs Act Introduced June 13, 2017 by Peter Welch (D-VT) To amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title. HR 2212 CREATES Act Introduced April 27, 2017 by Tom Marino (R-PA) To promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. HR 1409 Cancer Drug Parity Act of 2017 Introduced March 7, 2017 by Leonard Lance (R-NJ) To amend the Public Health Service Act to require group and individual health insurance coverage and group health plans to provide for cost sharing for oral anticancer drugs on terms no less favorable than the cost sharing provided for anticancer medications administered by a health care provider. HR 749 Lower Drug Cost Through Competition Act Introduced January 30, 2017 by Kurt Schrader (D-OR) To increase competition in the pharmaceutical industry. HR 4666 Premium Relief Act Introduced December 18, 2017 by Ryan Costello (R-PA) To amend the Public Health Service Act to provide for a Patient and State Stability Fund. HR 3976 Access to Marketplace Insurance Act Introduced October 5, 2017 by Kevin Cramer (R-ND) To amend the Patient Protection and Affordable Care Act to allow for certain third-party payments. 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 5228 SCREEN Act Introduced March 8, 2018 by Frank Pallone, Jr. (D-NJ) H.R. 5228 will provide the Food and Drug Administration (FDA) with stronger recall and seizure authority to disrupt the entry of counterfeit and illicit drugs through International Mail Facilities (IMFs). HR 5752 Stop Illicit Drug Importation Act of 2018 Introduced May 10, 2018 by Marsha Blackburn (R-TN) amends the Federal Food, Drug, and Cosmetic Act (FD&C) to strengthen the Food and Drug Administrations (FDA) seizure powers and enhance its authority to detain, refuse, seize, or destroy illegal products offered for import. The legislation would subject more people to debarment and civil penalties under the Act. HR 5806 21st Century Tools for Pain and Addiction Treatment Act Introduced May 15, 2018 by Michael Burgess(R-TX) To require the Secretary of Health and Human Services to issue guidance with respect to the expedited approval of certain drugs, and for other purposes. HR 5811 Long-Term Opioid Efficacy Act of 2018 Introduced May 15, 2018 by Jerry McNerney (D-CA) To amend the Federal Food, Drug, and Cosmetic Act with respect to postapproval study requirements for certain controlled substances, and for other purposes. HR 1925 At-Risk Youth Medicaid Protection Act of 2018 Introduced April 5, 2017 by Tony Cardenas (D-CA) To amend title XIX of the Social Security Act to protect at-risk youth against termination of Medicaid eligibility while an inmate of a public institution. HR 3192 CHIP Mental Health Parity Act To amend title XXI of the Social Security Act to ensure access to mental health services for children under the Children's Health Insurance Program, and for other purposes. HR 4005 Medicaid Reentry Act Directs the Secretary of Health and Human Services to convene a group of stakeholders and develop and report to Congress on best practices for addressing issues related to health care faced by those returning from incarceration to their communities. In addition, the legislation allows Medicaid payment for medical services furnished to an incarcerated individual during the 30-day period preceding the individuals release. HR 4998 Health Insurance for Former Foster Youth Act Introduced February 13, 2018 by Karen Bass (D-CA) To amend title XIX of the Social Security Act to ensure health insurance coverage continuity for former foster youth. HR 5477 Rural DOCS Act Introduced April 11, 2018 by Tom OHalleran (D-AZ) To amend title XIX of the Social Security Act to provide for a demonstration project to increase substance use provider capacity under the Medicaid program. HR 5583 Introduced April 23, 2018 by Yvette Clark (D-NY) requires states to include behavioral health indicators in their annual reports on the quality of care under Medicaid beginning in 2024. The Affordable Care Act (Section 1139B) requires the Secretary of HHS to identify and publish a core set of health care quality measures for adult Medicaid enrollees. The law requires that measures designated for the core set be currently in use. To aid in the assessment of the quality of care for Medicaid-eligible adults, the law calls for HHS to: develop a standardized reporting format for the core set of measures; establish an adult quality measurement program; issue an annual report by the Secretary on the reporting of adult Medicaid quality information; and publish updates to the initial core set of adult health quality measures that reflect new or enhanced quality measures. In the Center for Medicare and Medicaid Services 2018 Core Set of Adult Health Care Quality Measures for Medicaid, there are 11 behavioral health measures included. Under current law, states already voluntarily report many of these measures annually. HR 5789 Introduced May 15, 2018 by Bill Foster (D-IL) To amend title XIX of the Social Security Act to provide for Medicaid coverage protections for pregnant and post-partum women while receiving inpatient treatment for a substance use disorder, and for other purposes. HR 5797 Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act Introduced May 15, 2018 by Mimi Walters (D-CA) Allows state Medicaid programs to remove the Institutions for Mental Diseases (IMD) exclusion for Medicaid beneficiaries aged 21 to 64 with an opioid use disorder for fiscal years 2019 to 2023. By removing the exclusion, Medicaid would pay for up to 30 total days of care in an IMD during a 12-month period for eligible individuals. Opioid use disorder as defined in H.R. 5797 includes, but is not limited to: heroin, fentanyl, oxycodone, tramadol and oxycodone. In addition, the legislation requires states to include in their State plan amendment information on 1) How the State will improve access to outpatient care during the State plan amendment period. 2) The process for transitioning individuals to appropriate. HR 5799 Medicaid Drug Review, Utilization, Good Governance Improvement Act Introduced May 15, 2018 by Marsha Blackburn (R-TN) To amend title XIX of the Social Security Act to require as a condition of receipt of full Federal medical assistance percentage under Medicaid that State Medicaid plans have in place certain drug utilization review activities. HR 5800 Introduced May 15, 2018 by Fred Upton (R-MI) directs the Medicaid and CHIP Payment and Access Commission (MACPAC) to conduct a study on institutions for mental disease that receive Medicaid reimbursement. The study shall report on the requirements and standards that state Medicaid programs have in place for institutions for mental diseases (IMD). MACPAC shall summarize the findings and make recommendations on best practices and data collection no later than January 2020. HR 5801 Medicaid Providers Are Required To Note Experiences in Record Systems to Help In-need Patients Act Introduced May 15, 2018 by Morgan Griffith (R-VA) To amend title XIX of the Social Security Act to provide for requirements under the Medicaid program relating to the use of qualified prescription drug monitoring programs and prescribing certain controlled substances. HR 5808 Medicaid Pharmaceutical Home Act of 2018 Introduced May 15, 2018 by Gus Bilirakis (R-FL) To amend title XIX of the Social Security Act to require States to operate drug management programs for at-risk beneficiaries, and for other purposes. HR 5810 Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act Introduced May 15, 2018 by Leonard Lance (R-NJ) To amend title XIX of the Social Security Act to provide for an extension of the enhanced FMAP for certain Medicaid health homes for individuals with substance use disorders. HR 5715 Strengthening Partnerships to Avoid Opioid Abuse Act Introduced May 9, 2018 by James Renacci (R-OH) To amend title XVIII of the Social Security Act to provide for certain program integrity transparency measures under Medicare parts C and D. HR 5716 COMPASS Act Introduced May 9, 2018 by Peter Roskam (R-IL) To amend title XVIII of the Social Security Act to provide for certain program integrity transparency measures under Medicare parts C and D. HR 5796 Responsible Education Achieves Care and Healthy Outcomes for Users Treatment Act of 2018 Introduced May 15, 2018 by Brian Fitzpatrick (R-PA) To require the Secretary of Health and Human Services to provide grants for eligible entities to provide technical assistance to outlier prescribers of opioids, and for other purposes. HR 5590 Opioid Addiction Action Plan Act Introduced April 24, 2018 by Adam Kinzinger (R-IL) To require the Secretary of Health and Human Services to provide for an action plan on recommendations for changes under Medicare and Medicaid to prevent opioids addictions and enhance access to medication-assisted treatment, and for other purposes. HR 5603 Access to Telehealth Services for Substance Use Disorders Act Introduced April 24, 2018 by Doris Matsui (D-CA) To amend title XVIII of the Social Security Act to provide the Secretary of Health and Human Services authority to waive certain Medicare telehealth requirements in the case of certain treatment of an opioid use disorder or co-occurring mental health disorder. HR 5605 Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act Introduced April 24, 2018 by Raul Ruiz (D-CA) establishes a four-year demonstration program to increase access to treatment for opioid use disorder. The demonstration would provide incentive payments and funding for care management services based on criteria such as patient engagement, use of evidence-based treatments, and treatment length and intensity. Under the bill, the Secretary of Health and Human Services would be directed to encourage other payers to coordinate payments for opioid use disorder treatments and to evaluate the extent to which the demonstration reduces hospitalizations, increases the use of medication-assisted treatments, and improves the health outcomes of individuals with opioid use disorders during and after the demonstration. This bill also incorporates H.R. 3528, Every Prescription Conveyed Securely Act, which would require e-prescribing, with exceptions, for coverage of prescribed controlled substances under the Medicare Part D program. HR 5798 Opioid Screening and Chronic Pain Management Alternatives for Seniors Act Introduced May 15, 2018 by Larry Bucshon (R-IN) To amend title XVIII of the Social Security Act to require a review of current opioid prescriptions for chronic pain and screening for opioid use disorder to be included in the Welcome to Medicare initial preventive physical examination. HR 4684 Ensuring Access to Quality Sober Living Act of 2018 Introduced December 19, 2017 by Judy Chu (D-CA) Authorizes the Substance Abuse and Mental Health Services Administration to develop, publish, and disseminate best practices for operating recovery housing that promotes a safe environment and sustained recovery from substance use disorders. Recovery housing is increasingly recognized as critical to recovery for many individuals, and includes activities and programs such as mediation, one-on-one counseling, group sessions, peer recovery support, medication management, spiritual engagement, and others. HR 5329 Poison Center Network Enhancement Act of 2018 Introduced March 19, 2018 by Susan Brooks (D-IN) reauthorizes the national network of Poison Control Centers. Specifically, the legislation reauthorizes the toll-free number, national media campaign, and grant program under the Public Health Service Act. The legislation increases the share of poison control center funding that could be provided through federal grants, and authorizes $30 million per year over the 2019-2023 period. HR 5580 STOP Fentanyl Deaths Act of 2018 Introduced April 23, 2018 by Ann Kuster (D-NH) To authorize the Secretary of Health and Human Services to conduct programs to address the usage of illicit drugs, particularly fentanyl, and for other purposes. HR 5587 Peer Support Communities of Recovery Act Introduced April 23, 2018 by Ben Lujan (D-NM) enhances the Comprehensive Addiction and Recovery Acts Building Communities of Recovery Program and authorizes the Department of Health and Human Services (HHS) to award grants to peer support specialist organizations for the development and expansion of recovery services. Grants shall be awarded to nonprofit organizations that support community-based, peer delivered support, including technical support for the establishment of recovery community organizations, independent, nonprofit groups led by people in recovery and their families. HR 5804 Post-Surgical Injections as an Opioid Alternative Act Introduced May 15, 2018 by John Shimkus (R-IL) To amend title XVIII of the Social Security Act to provide for modifications in payment for certain outpatient surgical services. HR 5809 Postoperative Opioid Prevention Act of 2018 Introduced May 15, 2018 by Scott Peters (D-CA) To amend title XVIII of the Social Security Act to encourage the use of non-opioid analgesics for the management of post-surgical pain under the Medicare program, and for other purposes. HR 5795 Overdose Prevention and Patient Safety Act Introduced May 15, 2018 by Earl Blumenauer (D-OR) To amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records. HR 5812 Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 Introduced May 15, 2018 by Morgan Griffith (R-VA) Will authorize the Centers for Disease Control and Prevention to carry out certain controlled substances overdose prevention and surveillance activities in order to improve data collection and integration into physician clinical workflow so that timely, complete, and accurate information will get into the hands of providers and dispensers so that they can make the best clinical decisions for their patients. HR 449 Synthetic Drug Awareness Act of 2018 Introduced January 11, 2017 by Hakeem Jeffries (D-NY) requires the U.S. Surgeon General to report to Congress on the public health effects of the rise in synthetic drug use among youth aged 12 to 18 years old in order to further educate parents and the medical community on the health effects of synthetics. HR 4284 INFO Act Introduced November 7, 2017 by Robert Latta (R-OH) directs the Department of Health and Human Services (HHS) to create a public and easily accessible electronic dashboard linking to all of the nationwide efforts to combat the opioid crisis. In addition, the legislation creates an Interagency Substance Use Disorder Coordinating Committee to review and coordinate opioid use disorder (OUD) and other substance use disorder (SUD) research, services, and prevention activities across all relevant Federal agencies, evaluate the effectiveness of these activities, and make specific recommendations for actions that agencies can take to better coordinates the administration of services for patients with OUD and SUD. HR 5002 Advancing Cutting Edge Research Act Introduced February 18, 2018 by Debbie Dingell (D-MI) Provides the National Institutes of Health new authorities to conduct research on innovative non-addictive pain medications. HR 5102 Substance Use Disorder Workforce Loan Repayment Act of 2018 Introduced February 27, 2018 by Katherine Clark (D-MA) creates a loan repayment program for substance use disorder (SUD) treatment providers. Specifically, the legislation offers student loan repayment of up to $250,000 for participants who agree to work as a SUD treatment professional in areas most in need of their services. The program is available to a wide range of direct care providers, including physicians, registered nurses, social workers, and other behavioral health professionals. The bill authorizes $25 million a year for the 2019-2028 period. HR 5009 Jessies Law Introduced February 13, 2018 by Tim Walberg (R-MI) Ensures medical professionals have access to a consenting patients complete health information when making treatment decisions by requiring the Department of Health and Human Services (HHS) to develop and annually disseminate best practices regarding the prominent display of substance use disorder (SUD) history in records of patients who have previously provided this information to a health care provider. HR 5176 Preventing Overdoses While in Emergency Rooms Act of 2018 Introduced March 6, 2018 by David McKinley (R-VA) requires the Secretary of the Department of Health and Human Services (HHS) to develop protocols and a grant program for health care providers to address the needs of people who survive a drug overdose. Specifically, the protocols would address the provision of naloxone upon discharge, connection with peer-support specialists, and the referral to treatment and other services that best fit the patients needs. The bill authorizes $50 million in FY2019 for the grant program. HR 5197 ALTO Act Introduced March 7, 2018 by Bill Pascrell, Jr. (D-NJ) Directs the Secretary of Health and Human Services (HHS) to carry out a demonstration program to test alternative pain management protocols to limit the use of opioids in hospital emergency departments. Following the completion of the three-year demonstration, the Secretary of Health and Human Services will submit a report to Congress on the results of the program and issue recommendations for broader implementation. The legislation authorizes $10 million annually in grants for fiscal years 2019-2021.

Client expense: $1,880,000 · 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), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of the Vice President of the United States, SENATE, Vice President of the U.S., White House Office