No Surprises for COVID–19 Tests Act

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: To amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes H.R.6833: Affordable Insulin Now Act H.R.6963: Accelerated Approval Integrity Act H.R.7008: Pre-approval Information Exchange Act H.R.7032: Increasing Transparency in Generic Drug Applications Act H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7666: Restoring Hope for Mental Health and Well-Being Act H.R.7667: Food and Drug Amendments of 2022 H.R.7828: To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years; (PRICED Act) S.4293: Pharmacy Benefit Manager Transparency Act S.4348: A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; (FDASLA Act) H.R.7995: GOLD CARD Act H.R.5376: The Inflation Reduction Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

Client expense: $1,908,258 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE

Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, direct and indirect remuneration (DIR), pharmacy networks, and mail-service pharmacy Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2355: Opioid Prescription Verification Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524: Health Care PRICE Transparency Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act S.2164: Lower Costs More Cures Act H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.4293: Pharmacy Benefit Manager Transparency Act 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

H.R. 145 - Continuing Coverage for Preexisting Conditions Act of 2021 - Rep. Joyce, David P. - preexisting conditions H.R. 526 - Ensuring Coverage in Public Health Emergencies Act of 2021 - Rep. Doggett, Lloyd - SEP H.R. 533 - Stop COVID-19 Test Surprise Medical Bills Act of 2021 - Rep. Fletcher, Lizzie - COVID-19 diagnostic testing H.R. 689 - Premium Relief Act of 2021 - Rep. Burgess, Michael - Patient and State Stability Fund H.R. 796 - Coverage for COVID-19 Treatment Act of 2021 - Rep. Blunt Rochester, Lisa - COVID-19 H.R. 892 - Pre-existing Conditions Protection Act of 2021 - Rep. McMorris Rodgers, Cathy - preexisting conditions H.R. 898 - Care for COVID-19 Act of 2021 - Rep. Ruiz, Raul - COVID-19 H.R. 1790 - Fair Indexing for Health Care Affordability Act - Rep. Axne, Cynthia - MOOP & premium tax credit eligibility H.R. 1795 - Expanded Coverage for Former Foster Youth Act - Rep. Bass, Karen - coverage for foster youth H.R. 1796 - Health Care Enrollment Innovation Act- Rep. Bera, Ami - state innovations and insurance coverage H.R. 1806 - ENROLL Act of 2021- Rep. Castor, Kathy - navigator program H.R. 1874 - Expand Navigators Resources for Outreach, Learning, and Longevity Act of 2021 - Rep. Castor, Kathy - navigator program H.R. 1875 - To amend title XXVII of the Public Health Service Act to eliminate the short-term limited duration insurance exemption with respect to individual health insurance coverage - Rep. Castor, Kathy - short-term limited duration insurance H.R. 1878 - State Health Care Premium Reduction Act of 2021 - Rep. Craig, Angie - affordability H.R. 1916 - Ensuring Lasting Smiles Act - Rep. Eshoo, Anna G - diagnosis and treatment of a congenital anomaly or birth defect H.R. 2264 - Tele-Mental Health Improvement Act - Rep. Trone, David - mental health and SUD H.R. 5376 - Inflation Reduction Act - Rep. Yarmuth, John A. - ACA premium tax credits, Medicaid redeterminations, PHE phase down H.R. 5981 - Telehealth Expansion Act - Rep. Steel, Michelle - treatment of telehealth services under a high deductible plan H.R. 6851 - No Surprises for COVID-19 Tests Act - Rep. Pallone, Frank, Jr. - COVID-19 test coverage S. 263 - Worker Health Coverage Protection Act - Sen. Durbin, Richard - coverage continuity & COBRA S. 380 - Health Savings Act of 2021 - Sen. Rubio, Marco - HSAs S. 499 - Improving Health Insurance Affordability Act of 2021 - Sen. Shaheen, Jeanne - cost-sharing subsidies S. 660 - Tele-Mental Health Improvement Act - Sen. Smith, Tina - telehealth parity in mental health and SUD coverage S. 756 - Continuing Coverage for Preexisting Conditions Act of 2021 - Sen. Kennedy, John -preexisting conditions S. 934 - Strengthening Rural Health Clinics Act of 2021 - Sen. Warner, Mark - rural health clinic payments S. 942 - No Junks Plans Act - Sen. Baldwin, Tammy - Short-Term, Limited Duration Insurance S. 1704 - Telehealth Expansion Act of 2021 - Sen. Daines, Steve - treatment of telehealth services under a high deductible 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 COBRA continuation coverage; issues related to behavioral health benefits; 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 COVID-19, including testing, vaccines and therapeutics; issues related to the cost of insulin, including price, copays, rebates, and medical management tools; issues related to health equity; issues related to vaccination; issues related to coverage in non-Medicaid Expansion States (e.g., Gap Population); issues related to the No Surprises Act, enacted as part of the Consolidated Appropriations Act in December 2020, including disclosure of agent broker compensation (Section 202c); issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; issues related to changes to prior authorization regulations, electronic documentation, and related issues; issues related to specialty infant formula; issues related to coverage of crisis services; issues related to kidney dialysis; issues relating to Medicaid best price; 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; prior authorization; accountable care organizations; coverage of preventive services; contraceptive coverage and reproductive health; 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 surprise medical bills; issues related to all payor claims databases; issues related to association health plans; issues related to substance abuse and provider treatment records (42 CFR Part 2); issues related to medical management; 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 related to interoperability and price transparency; issues related to the employer market; issues relating to the individual market; and other issues relating to health care reform implementation.

issues related to diagnostic testing, issues related to responding to the current COVID-19 pandemic and future pandemics; S. 2209/H.R. 4128, the Verifying Accurate Leading-Edge IVCT Development Act of 2021 (VALID); S. 3799 the PREVENT Pandemics Act; H.R. 6851, No Surprises for COVID-19 Tests Act.

Client expense: $140,000 · Firm income: Not reported

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

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: To amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes H.R.6833: Affordable Insulin Now Act H.R.6963: Accelerated Approval Integrity Act H.R.7008: Pre-approval Information Exchange Act H.R.7032: Increasing Transparency in Generic Drug Applications Act H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7666: Restoring Hope for Mental Health and Well-Being Act H.R.7667: Food and Drug Amendments of 2022 H.R.7828: To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years; (PRICED Act) S.4293: Pharmacy Benefit Manager Transparency Act S.4348: A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; (FDASLA Act) H.R.7995: GOLD CARD Act 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, direct and indirect remuneration (DIR), pharmacy networks, and mail-service pharmacy Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2355: Opioid Prescription Verification Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524: Health Care PRICE Transparency Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act S.2164: Lower Costs More Cures Act H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.4293: Pharmacy Benefit Manager Transparency Act 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

issues related to diagnostic testing, issues related to responding to the current COVID-19 pandemic and future pandemics; S. 2209/H.R. 4128, the Verifying Accurate Leading-Edge IVCT Development Act of 2021 (VALID); S. 3799 the PREVENT Pandemics Act; H.R. 6851, No Surprises for COVID-19 Tests Act.

Client expense: $140,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

H.R. 145 - Continuing Coverage for Preexisting Conditions Act of 2021 - Rep. Joyce, David P. - preexisting conditions H.R. 526 - Ensuring Coverage in Public Health Emergencies Act of 2021 - Rep. Doggett, Lloyd - SEP H.R. 533 - Stop COVID-19 Test Surprise Medical Bills Act of 2021 - Rep. Fletcher, Lizzie - COVID-19 diagnostic testing H.R. 689 - Premium Relief Act of 2021 - Rep. Burgess, Michael - Patient and State Stability Fund H.R. 796 - Coverage for COVID-19 Treatment Act of 2021 - Rep. Blunt Rochester, Lisa - COVID-19 H.R. 892 - Pre-existing Conditions Protection Act of 2021 - Rep. McMorris Rodgers, Cathy - preexisting conditions H.R. 898 - Care for COVID-19 Act of 2021 - Rep. Ruiz, Raul - COVID-19 H.R. 1790 - Fair Indexing for Health Care Affordability Act - Rep. Axne, Cynthia - MOOP & premium tax credit eligibility H.R. 1795 - Expanded Coverage for Former Foster Youth Act - Rep. Bass, Karen - coverage for foster youth H.R. 1796 - Health Care Enrollment Innovation Act- Rep. Bera, Ami - state innovations and insurance coverage H.R. 1806 - ENROLL Act of 2021- Rep. Castor, Kathy - navigator program H.R. 1874 - Expand Navigators Resources for Outreach, Learning, and Longevity Act of 2021 - Rep. Castor, Kathy - navigator program H.R. 1875 - To amend title XXVII of the Public Health Service Act to eliminate the short-term limited duration insurance exemption with respect to individual health insurance coverage - Rep. Castor, Kathy - short-term limited duration insurance H.R. 1878 - State Health Care Premium Reduction Act of 2021 - Rep. Craig, Angie - affordability H.R. 1916 - Ensuring Lasting Smiles Act - Rep. Eshoo, Anna G - diagnosis and treatment of a congenital anomaly or birth defect H.R. 2264 - Tele-Mental Health Improvement Act - Rep. Trone, David - mental health and SUD H.R. 5376 - Build Back Better Act - Rep. Yarmuth, John A. - ACA premium tax credits, Medicaid redeterminations, PHE phase down H.R. 5981 - Telehealth Expansion Act - Rep. Steel, Michelle - treatment of telehealth services under a high deductible plan H.R. 6851 - No Surprises for COVID-19 Tests Act - Rep. Pallone, Frank, Jr. - COVID-19 test coverage S. 263 - Worker Health Coverage Protection Act - Sen. Durbin, Richard - coverage continuity & COBRA S. 380 - Health Savings Act of 2021 - Sen. Rubio, Marco - HSAs S. 499 - Improving Health Insurance Affordability Act of 2021 - Sen. Shaheen, Jeanne - cost-sharing subsidies S. 660 - Tele-Mental Health Improvement Act - Sen. Smith, Tina - telehealth parity in mental health and SUD coverage S. 756 - Continuing Coverage for Preexisting Conditions Act of 2021 - Sen. Kennedy, John - preexisting conditions S. 934 - Strengthening Rural Health Clinics Act of 2021 - Sen. Warner, Mark - rural health clinic payments S. 942 - No Junks Plans Act - Sen. Baldwin, Tammy - Short-Term, Limited Duration Insurance S. 1704 - Telehealth Expansion Act of 2021 - Sen. Daines, Steve - treatment of telehealth services under a high deductible 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 COBRA continuation coverage; issues related to behavioral health benefits; 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 COVID-19, including testing, vaccines and therapeutics; issues related to the cost of insulin, including price, copays, rebates, and medical management tools; issues related to health equity; issues related to vaccination; issues related to coverage in non-Medicaid Expansion States (e.g., Gap Population); issues related to the No Surprises Act, enacted as part of the Consolidated Appropriations Act in December 2020, including disclosure of agent broker compensation (Section 202c); issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; issues related to changes to prior authorization regulations, electronic documentation, and related issues; issues relating to Medicaid best price; 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; issues related to repeal of the antitrust-related portions of the McCarran-Ferguson Act; implementation of the Mental Health Parity Act requirements; implementation of the 21st Century Cures Act requirements; summary of benefits and coverage disclosures; prior authorization; accountable care organizations; coverage of preventive services; contraceptive coverage and reproductive health; 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 surprise medical bills; issues related to all payor claims databases; issues related to association health plans; issues related to substance abuse and provider treatment records (42 CFR Part 2); issues related to medical management; 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 related to interoperability and price transparency; issues related to the employer market; issues relating to the individual market; and other issues relating to health care reform implementation.

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: To amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2003 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, direct and indirect remuneration (DIR), pharmacy networks, and mail-service pharmacy Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2355: Opioid Prescription Verification Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524: Health Care PRICE Transparency Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act S.2164: Lower Costs More Cures Act H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2003 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

H.R. 145 - Continuing Coverage for Preexisting Conditions Act of 2021 - Rep. Joyce, David P. - preexisting conditions H.R. 526 - Ensuring Coverage in Public Health Emergencies Act of 2021 - Rep. Doggett, Lloyd - SEP H.R. 533 - Stop COVID-19 Test Surprise Medical Bills Act of 2021 - Rep. Fletcher, Lizzie - COVID-19 diagnostic testing H.R. 689 - Premium Relief Act of 2021 - Rep. Burgess, Michael - Patient and State Stability Fund H.R. 796 - Coverage for COVID-19 Treatment Act of 2021 - Rep. Blunt Rochester, Lisa - COVID-19 H.R. 892 - Pre-existing Conditions Protection Act of 2021 - Rep. McMorris Rodgers, Cathy - preexisting conditions H.R. 898 - Care for COVID-19 Act of 2021 - Rep. Ruiz, Raul - COVID-19 H.R. 1790 - Fair Indexing for Health Care Affordability Act - Rep. Axne, Cynthia - MOOP & premium tax credit eligibility H.R. 1795 - Expanded Coverage for Former Foster Youth Act - Rep. Bass, Karen - coverage for foster youth H.R. 1796 - Health Care Enrollment Innovation Act- Rep. Bera, Ami - state innovations and insurance coverage H.R. 1806 - ENROLL Act of 2021- Rep. Castor, Kathy - navigator program H.R. 1874 - Expand Navigators Resources for Outreach, Learning, and Longevity Act of 2021 - Rep. Castor, Kathy - navigator program H.R. 1875 - To amend title XXVII of the Public Health Service Act to eliminate the short-term limited duration insurance exemption with respect to individual health insurance coverage - Rep. Castor, Kathy - short-term limited duration insurance H.R. 1878 - State Health Care Premium Reduction Act of 2021 - Rep. Craig, Angie - affordability H.R. 1916 - Ensuring Lasting Smiles Act - Rep. Eshoo, Anna G. - diagnosis and treatment of a congenital anomaly or birth defect H.R. 2264 - Tele-Mental Health Improvement Act - Rep. Trone, David - mental health and SUD H.R. 5981 -Telehealth Expansion Act - Rep. Steel, Michelle - treatment of telehealth services under a high deductible plan H.R. 6851 - No Surprises for COVID-19 Tests Act - Rep. Pallone, Frank, Jr. - COVID-19 test coverage S. 263 - Worker Health Coverage Protection Act - Sen. Durbin, Richard - coverage continuity & COBRA S. 380 - Health Savings Act of 2021 - Sen. Rubio, Marco - HSAs S. 499 - Improving Health Insurance Affordability Act of 2021 - Sen. Shaheen, Jeanne - cost-sharing subsidies S. 660 - Tele-Mental Health Improvement Act - Sen. Smith, Tina - telehealth parity in mental health and SUD coverage S. 756 - Continuing Coverage for Preexisting Conditions Act of 2021 - Sen. Kennedy, John -preexisting conditions S. 934 - Strengthening Rural Health Clinics Act of 2021 - Sen. Warner, Mark - rural health clinic payments S. 942 - No Junks Plans Act - Sen. Baldwin, Tammy - Short-Term, Limited Duration Insurance S. 1704 - Telehealth Expansion Act of 2021 - Sen. Daines, Steve - treatment of telehealth services under a high deductible 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 COBRA continuation coverage; issues related to behavioral health benefits; 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 COVID-19, including testing, vaccines and therapeutics; issues related to the cost of insulin, including price, copays, rebates, and medical management tools; issues related to health equity; issues related to vaccination; issues related to coverage in non-Medicaid Expansion States (e.g., Gap Population); issues related to the No Surprises Act, enacted as part of the Consolidated Appropriations Act in December 2020, including disclosure of agent broker compensation (Section 202c); issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; issues related to changes to prior authorization regulations, electronic documentation, and related issues; issues relating to Medicaid best price; 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; issues related to repeal of the antitrust-related portions of the McCarran-Ferguson Act; implementation of the Mental Health Parity Act requirements; implementation of the 21st Century Cures Act requirements; summary of benefits and coverage disclosures; prior authorization; 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 surprise medical bills; issues related to all payor claims databases; issues related to association health plans; issues related to substance abuse and provider treatment records (42 CFR Part 2); issues related to medical management; 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 related to interoperability and price transparency; issues related to the employer market; issues relating to the individual market; and other issues relating to health care reform implementation.

issues related to diagnostic testing, issues related to responding to the current COVID-19 pandemic and future pandemics; S. 2209/H.R. 4128, the Verifying Accurate Leading-Edge IVCT Development Act of 2021 (VALID); S. 3799 the PREVENT Pandemics Act; H.R. 6851, No Surprises for COVID-19 Tests Act.

Client expense: $140,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office