Phair Pricing Act of 2018

Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Support H.R. 2871, Preserving Patient Access to Compounded Medications Act. Support H.R. 1316, Prescription Drug Price Transparency Act Support S. 637, C-THRU Act. Support H.R. 5958, Phair Pricing Act Support sunscreen related provisions in S. 2315, OTC Drug Safety, Innovation & Reform Act/H.R. 5333, OTC Monograph Safety, Innovation, & Reform Act; provisions also included in H.R. 7328, Pandemic and All-Hazards Preparedness and Advancing Innovation Act.

Client expense: $360,000 · Firm income: Not reported

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

H.R. 1316, Prescription Drug Price Transparency Act; H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act; S. 413, Improving Transparency and Accuracy in Medicare Part D Spending Act; H.R. 592, Pharmacy and Medically Underserved Areas Enhancement Act; S. 109, Pharmacy and Medically Underserved Areas Enhancement Act; H.R.1939 - To amend title XVIII of the Social Security Act to ensure equal access of Medicare beneficiaries to community pharmacies in underserved areas as network pharmacies under Medicare prescription drug coverage, and for other purposes; S.637 Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; HR 394/ S 85, Restoring Access to Medication Act; HR 3921/S 1827, KIDS Act of 2017; HR 3271, Protecting Access to Diabetes Supplies Act of 2017; S. 870, Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017; Centers for Medicare and Medicaid Services (CMS) Proposed Rule for the 2019 Medicare Part D Plan Year, pharmacy provisions; S.2553 / H.R. 6144, Know the Lowest Price Act of 2018; S.2554 / H.R. 6143, Patient Right to Know Drug Prices Act; H.R. 5343, Prescription Transparency Act of 2018; H.R. 5958, Phair Pricing Act of 2018; CMS Call Letter for 2019 Medicare Part D and Medicare Advantage Plans; H.R. 6733, Know the Cost Act of 2018; H.R. 6641, COST Act; H.R. 7339, Medicare for America Act of 2018; Proposed Rule, "Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses, CMS-4180-P"

Client expense: $240,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Personnel Management (OPM), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

H.R. 1245/S. 469 The Affordable and Safe Prescription Drug Importation Act H.R. 1316 - Prescription Drug Price Transparency Act H.R. 749 Lower Drug Costs Through Competition H.R.2430/S. 934 - FDA Reauthorization Act of 2017 H.R. 4841 - Standardizing Electronic Prior Authorization for Safe Prescribing Act H.R. 6733 - Know the Cost Act H.R. 6143/ S. 2554 - Patient Right to Know Drug Prices Act H.R. 6144/ S. 2553 - Know the Lowest Price Act H.R. 6641 - True Cost-sharing of Seniors Drugs Transparency (True COST) Act H.R. 5958 - Phair Pricing Act

Client expense: $640,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Issues related to pharmaceutical manufacturer and pharmacy contracting with respect to drug pricing. Regulatory and proposed legislative changes to Medicare Part D including non-interference, Direct and Indirect Remuneration (DIR), pharmacy networks, classes of clinical concern, mail-service pharmacy and safe harbors related to manufacturer rebates. Issues related to the management of Medicaid prescription drug benefits. Issues related to prescription drug abuse in Medicare and Medicaid. Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, implementation of the prescriber registration rules and definition of negotiated price. Regulatory design and coverage of pharmacy benefits. Issues related to Medicaid Provider Enrollment. Issues related to the Medicare Coverage Gap Discount. H.R.1038/S.413, Improving Transparency and Accuracy in Part D Spending Act H.R.1316, Prescription Drug Price Transparency Act S.637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 S.771, Improving Access to Affordable Prescription Drug ActH.R.1939/S.1044, Ensuring Seniors Access to Local Pharmacies ActH.R.3528/S.2460, The Every Prescription Carried Safely Act S.2553/H.R.6144, Know the Lowest Price Act of 2018 S.2554/H.R.6143, Patient Right to Know Drug Prices Act H.R.4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 H.R.5958, Fair Pricing Act of 2018 H.R.5343, Prescription Transparency Act of 2018

Client expense: $656,680 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE

Issues related to prescription drug abuse and Medicare Part D. S.413/H.R. 1039, The Improving Transparency and Accuracy in Medicare Part D Spending Act of 2017 H.R.1316, The Prescription Drug Price Transparency Act of 2017 S. 2553/H.R. 6144, The Know the Lowest Price Act of 2018 H.R. 5958, The Phair Pricing Act of 2018 H.R. 4143/S. 2065, The Dialysis PATIENTS Demonstration Act of 2017

Client expense: $1,442,000 · Firm income: Not reported

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

Stopping the application of the sequester cut (current and new) to Medicare Part B drug reimbursement (no bill). Fixing the 340B drug discount program, including PAUSE Act (H.R. 4710), HELP Act (S. 2312, and Ensuring the Value of the 340B Program Act (S. 2453) and other legislation in progress. Fixing Medicare Part B drug reimbursement by eliminating the manufacturer-to-wholesaler prompt pay discount from the calculation of average sales price, the basis of Part B drug reimbursement (H.R. 1920, S. 1304). Moving Medicare Part B to Part D (no bill). Misc. issues dealing with pharmacy benefit managers and patient and pharmacy abuses (includes bills H.R 1316 - Prescription Drug Price Transparency Act; H.R.1038 - Improving Transparency and Accuracy in Medicare Part D Spending Act; and H.R. 5958 - Phair Pricing Act of 2018}. Oncology Care Model (CMS/CMMI; no bill). Various drug pricing/costs (no bill). VA clawback of payments made to community oncology practices for treating veterans out of network. STEP therapy (no bill).

Client expense: $122,500 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)

Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Lobby members of Congress to support H. Res. 282 to encourage proper sun safety practices for youth under care of schools and camps. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 2871, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077, Restoring Patients Voice Act. Support H.R. 1316, Prescription Drug Price Transparency Act. Support H.R. 2051, Fair Access for Safe and Timely Generics Act. Support H.R. 2212/S. 974, Creating and Restoring Equal Access to Equivalent Samples Act. Support H.R. 2999, Patients Access to Treatments Act. Support H.R. 3928, the Truth in Healthcare Marketing Act of 2017. Support S. 637, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support S. 2553, Know the Lowest Prices Act. Support S. 2554, Patient Right to Know Drug Prices Act. Support H.R. 5958, Phair Pricing Act. Support H.R. 5343, Prescription Transparency Act. Support H.R. 6689/S. 3368, Ensuring Lasting Smiles Act. Advocate for relief for from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 4841/H.R. 5773/Section 6062 of H.R. 6 (SUPPORT for Patients & Communities Act), Standardizing Electronic Prior Authorization for Safe Prescribing Act and S. 2908, Electronic Prior Authorization in Medicare Part D Act. Support sunscreen related provisions in S. 2315, OTC Drug Safety, Innovation & Reform Act/H.R. 5333, OTC Monograph Safety, Innovation, & Reform Act. Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Advocate for access to dermatological procedures for veterans through the Veterans Choice Program. Advocate for the continued funding of Community Health Centers. Advocate against including physician advocacy and membership organization in the Physician Payment Sunshine Act requirements as originally included in S. 3000; advocated against inclusion in S. Amendment 4013 to H.R. 6.

Client expense: $500,000 · Firm income: Not reported

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

Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Support H.R. 2871, Preserving Patient Access to Compounded Medications Act. Support H.R. 1316, Prescription Drug Price Transparency Act Support S. 637, C-THRU Act. Support S. 2553, Know the Lowest Price Act. Support S. 2554, Patient Right to Know Drug Prices Act. Support H.R. 5958, Phair Pricing Act. Support H.R. 5343, Prescription Transparency Act. Support sunscreen related provisions in S. 2315, OTC Drug Safety, Innovation & Reform Act/H.R. 5333, OTC Monograph Safety, Innovation, & Reform Act.

Client expense: $500,000 · Firm income: Not reported

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

S. 483 (114th Congress) legislation to prevent and reduce prescription drug abuse. H.R. 592 & S. 109, provide for coverage under Medicare program of pharmacist services. Medication Therapy Management. H.R. 1038 and S. 413, legislation to prohibit prescription drug plan sponsors and MAPD organizations under Medicare program from retroactively reducing payment on clean claims submitted by pharmacies. Pharmaceutical compounding and the implementation of Drug Quality Security Act; FDA implementation of Section 503B of the Food, Drug, and Cosmetic Act; House & Senate Agriculture, FDA & Related Agency Appropriations bills; H.R. 2871, Preserving Patient Access to Compounded Medications Act of 2017. Prescription Drug Importation including S. 771 and H.R. 1776, the Improving Access to Affordable Prescription Drugs Act and S.469, the Affordable and Safe Prescription Drug Importation Act. E-Prescribing bills including H.R. 3528 and S. 2460, the Every Prescription Conveyed Securely (EPCS) Act. H.R. 5958, Phair Pricing Act of 2018. HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. S. 3282 and H.R. 6600, the DEA Order Clearinghouse Act of 2018.

Client expense: $470,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

H.R. 1316-The Prescription Drug Price Transparency Act (MAC); H.R. 1038 & S.413-Improving Transparency and Accuracy in Medicare Part D Drug Spending Act (DIR); H.R. 1939 & S. 1044 - Ensuring Seniors Access to Local Pharmacies Act of 2017; S. 2553-Know the Lowest Price Act. CY2019 Medicare Part D Final Rule relating to direct and indirect renumeration fees; H.R.5958-The Phair Pricing Act of 2018.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation to address abuses of the REMS program to allow generic drugs to come to market faster. H.R.2212/S.974: CREATES Act--provisions related to removing barriers to generic competition. H.R.1316: The Prescription Drug Price Transparency Act--issues related to ensuring the continuity of MAC pricing. S.2460/H.R.3528: Every Prescription Conveyed Securely Act--provisions requiring electronic prescribing of controlled substances in Medicare Part D; provisions added through amendment to H.R. 6 that limit who can use analgesic prescribing guidelines (became HR 6; awaiting President's signature). S.2554: "Patient Right to Know Drug Prices Act,"--provisions to prohibit the use of gag clauses or require that beneficiaries be charged lower prices (now PL 115-263). H.R.5343: "Prescription Transparency Act of 2018,"-- provisions to prohibit the use of gag clauses or require that beneficiaries be charged lower prices. H.R.5958: The Phair Pricing Act of 2018, provisions related to the use of quality provisions and provisions to prohibit the use of gag clauses or require that beneficiaries be charged lower prices. H.R.6144: Know the Lowest Price Act -provisions to prohibit the use of gag clauses or require that beneficiaries be charged lower prices. Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, provisions affecting market competition for prescription drugs and the drug supply chain. H.R.5675: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries Provisions mandating a Medicare lock-in program for Medicare beneficiaries at risk for opioid abuse.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.2460/H.R.3528: Every Prescription Conveyed Securely Act--provisions requiring electronic prescribing of controlled substances in Medicare Part D; provisions added through amendment to H.R. 6 that limit who can use analgesic prescribing guidelines(became HR 6, which is awaiting President's signature). S.2554: "Patient Right to Know Drug Prices Act,"--provisions to prohibit the use of gag clauses or require that beneficiaries be charged lower prices (now PL 115-263). H.R.5343: "Prescription Transparency Act of 2018,"-- provisions to prohibit the use of gag clauses or require that beneficiaries be charged lower prices. H.R.5958: The Phair Pricing Act of 2018, provisions related to the use of quality provisions and provisions to prohibit the use of gag clauses or require that beneficiaries be charged lower prices. H.R.6144: Know the Lowest Price Act -provisions to prohibit the use of gag clauses or require that beneficiaries be charged lower prices. Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, provisions affecting market competition for prescription drugs and the drug supply chain. H.R.5675: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries; provisions mandating a Medicare lock-in program for Medicare beneficiaries at risk for opioid abuse.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.413/H.R.1038: Improving Transparency and Accuracy in Medicare Part D Spending Act--provisions restricting payer quality payment programs in Medicare Part D. S.771/H.R.1776: Improving Access to Affordable Prescription Drugs Act--issues related to ensuring a competitive marketplace for prescription drugs. H.R.1316: The Prescription Drug Price Transparency Act--issues related to ensuring the continuity of MAC pricing. S.2460/H.R.3528: Every Prescription Conveyed Securely Act--provisions requiring electronic prescribing of controlled substances in Medicare Part D; provisions added through amendment to H.R. 6 that limit who can use analgesic prescribing guidelines (became HR 6, awaiting President's signature). Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program Proposed Rule & Request for Information --Provisions on Part D. H.R.5343: "Prescription Transparency Act of 2018,"-- provisions to prohibit the use of gag clauses or require that beneficiaries be charged lower prices. S.2553: "Know the Lowest Price Act," --"-- provisions to prohibit the use of gag clauses or require that beneficiaries be charged lower prices (now PL 115-262). H.R.5958: The Phair Pricing Act of 2018, provisions related to the use of quality provisions and provisions to prohibit the use of gag clauses or require that beneficiaries be charged lower prices. H.R.6144: Know the Lowest Price Act -provisions to prohibit the use of gag clauses or require that beneficiaries be charged lower prices. Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, provisions affecting market competition for prescription drugs and the drug supply chain. H.R.5675: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries Provisions mandating a Medicare lock-in program for Medicare beneficiaries at risk for opioid abuse. CMS Proposed and Final Policy Changes and Updates for Medicare Advantage and the Prescription Drug Benefit Program for Contract Year 2019 (CMS-4182-P), provisions in a Request for Information related to rebates at the point-of-sale and pharmacist direct and indirect renumeration. H.R.6641: True Cost-sharing of Seniors Drugs Transparency Act provisions related to pharmacy gag clause. Proposed HHS-OIG rule currently under OMB review entitled, Removal of Safe Harbor Protections for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection, RIN-936-AAO8. (See https://www.reginfo.gov/public/do/eoReviewSearch for questions). Outreach and education on pharmacy Direction and Indirection Remuneration in Medicare.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1316, Prescription Drug Price Transparency Act; H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act; S. 413, Improving Transparency and Accuracy in Medicare Part D Spending Act; H.R. 592, Pharmacy and Medically Underserved Areas Enhancement Act; S. 109, Pharmacy and Medically Underserved Areas Enhancement Act; H.R.1939 - To amend title XVIII of the Social Security Act to ensure equal access of Medicare beneficiaries to community pharmacies in underserved areas as network pharmacies under Medicare prescription drug coverage, and for other purposes; S.637 Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; HR 394/ S 85, Restoring Access to Medication Act; HR 3921/S 1827, KIDS Act of 2017; HR 3271, Protecting Access to Diabetes Supplies Act of 2017; S. 870, Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017; Centers for Medicare and Medicaid Services (CMS) Proposed Rule for the 2019 Medicare Part D Plan Year, pharmacy provisions; S.2553 / H.R. 6144, Know the Lowest Price Act of 2018; S.2554 / H.R. 6143, Patient Right to Know Drug Prices Act; H.R. 5343, Prescription Transparency Act of 2018; H.R. 5958, Phair Pricing Act of 2018; CMS Call Letter for 2019 Medicare Part D and Medicare Advantage Plans; H.R. 6733, Know the Cost Act of 2018; H.R. 6641, COST Act

Client expense: $290,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Personnel Management (OPM), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

Medicare Direct and Indirect Remuneration; Drug Pricing Issues; HR 5958, PHAIR Pricing Act.

Client expense: Not reported · Firm income: $100,000

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

H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to controlled substances H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program HR 4993 Vaccine Access Improvement Act HR 4297/S 2103 Protecting Seniors Through Immunization Act H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 5687: SOUND Disposal and Packaging Act - To require improved packaging and disposal methods with respect to certain drugs H.R. 6142: Reducing Drug Waste Act of 2018 - Action plan and report on vial size waste HR 6378/S 2852 Pandemic and All Hazards Preparedness Act reauthorization HR 6294 REVAMP Act S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1327: SITSA Act - Provisions related to controlled substances S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues 340B drug discount program policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development of FDA policy TRICARE pharmacy pilot program Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49) Pandemic and All-Hazards Preparedness Act, provisions related to emerging infectious diseases and antimicrobial resistance. HR 6 - SUPPORT for Patients and Communities Act HR 5687 - SOUND Disposal and Packaging ActHR 5333 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 S 2315 - Over-the-Counter Drug Safety, Innovation, and Reform ActHR 394/S 85 - Restoring Access to Medication Act of 2017 HR 6199 - To amend the Internal Revenue Code of 1986 to include certain over-the-counter medical products as qualified medical expenses. HR 6157 - FY19 Defense Appropriations ActS 3159 - FY19 Defense Appropriations ActS 3158 - FY19 Labor-HHS-Education Appropriations ActHouse Draft - FY19 Labor-HHS-Education Appropriations ActPatient Access in Medicaid program340B Discount Drug ProgramHR 4710 - 340B PAUSE ActHR 5598 - 340B Optimization Act HR 5958 - Phair Pricing Act of 2018

Client expense: $1,400,000 · 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), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE

Issues related to prescription drug abuse and Medicare Part D. S.413/H.R. 1039, The Improving Transparency and Accuracy in Medicare Part D Spending Act of 2017 H.R.1316, The Prescription Drug Price Transparency Act of 2017 S. 2460/H.R. 3528, The Every Prescription Conveyed Securely Act of 2017 S. 2553/H.R. 6144, The Know the Lowest Price Act of 2018 H.R. 4841, The Standardizing Electronic Prior Authorization for Safe Prescribing Act H.R. 5958, The Phair Pricing Act of 2018

Client expense: $1,300,000 · Firm income: Not reported

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

S. 483 (114th Congress) legislation to prevent and reduce prescription drug abuse. H.R. 592 & S. 109, provide for coverage under Medicare program of pharmacist services. Medication Therapy Management. H.R. 1038 and S. 413, legislation to prohibit prescription drug plan sponsors and MAPD organizations under Medicare program from retroactively reducing payment on clean claims submitted by pharmacies. Pharmaceutical compounding and the implementation of Drug Quality Security Act; FDA implementation of Section 503B of the Food, Drug, and Cosmetic Act; House & Senate Agriculture, FDA & Related Agency Appropriations bills; H.R. 2871, Preserving Patient Access to Compounded Medications Act of 2017. Prescription Drug Importation including S. 771 and H.R. 1776, the Improving Access to Affordable Prescription Drugs Act and S.469, the Affordable and Safe Prescription Drug Importation Act. E-Prescribing bills including H.R. 3528 and S. 2460, the Every Prescription Conveyed Securely (EPCS) Act. H.R. 5958, Phair Pricing Act of 2018. HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.

Client expense: $460,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Lobby members of Congress to support H. Res. 282 to encourage proper sun safety practices for youth under care of schools and camps. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 2871, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077, Restoring Patients Voice Act. Support H.R. 1316, Prescription Drug Price Transparency Act. Support H.R. 2051, Fair Access for Safe and Timely Generics Act. Support H.R. 2212/S. 974, Creating and Restoring Equal Access to Equivalent Samples Act. Support H.R. 2999, Patients Access to Treatments Act. Support H.R. 3928, the Truth in Healthcare Marketing Act of 2017. Support S. 637, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act Support S. 2553, Know the Lowest Prices Act Support S. 2554, Patient Right to Know Drug Prices Act Support H.R. 5958, Phair Pricing Act Advocate for relief for from pior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 4841/H.R. 5773/Section 6062 of H.R. 6 (SUPPORT for Patients & Communities Act), Standardizing Electronic Prior Authorization for Safe Prescribing Act and S. 2908, Electronic Prior Authorization in Medicare Part D Act Support sunscreen related provisions in S. 2315, OTC Drug Safety, Innovation & Reform Act/H.R. 5333, OTC Monograph Safety, Innovation, & Reform Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Advocate for access to dermatological procedures for veterans through the Veterans Choice Program. Advocate for the continued funding of Community Health Centers.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, SENATE

Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Support H.R. 2871, Preserving Patient Access to Compounded Medications Act. Support H.R. 1316, Prescription Drug Price Transparency Act Support S. 637, C-THRU Act. Support S. 2553, Know the Lowest Price Act Support S. 2554, Patient Right to Know Drug Prices Act Support H.R. 5958, Phair Pricing Act Support sunscreen related provisions in S. 2315, OTC Drug Safety, Innovation & Reform Act/H.R. 5333, OTC Monograph Safety, Innovation, & Reform Act

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, SENATE

H.R. 1316, Prescription Drug Price Transparency Act; H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act; S. 413, Improving Transparency and Accuracy in Medicare Part D Spending Act; H.R. 592, Pharmacy and Medically Underserved Areas Enhancement Act; S. 109, Pharmacy and Medically Underserved Areas Enhancement Act; H.R.1939 - To amend title XVIII of the Social Security Act to ensure equal access of Medicare beneficiaries to community pharmacies in underserved areas as network pharmacies under Medicare prescription drug coverage, and for other purposes; S.637 Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; HR 394/ S 85, Restoring Access to Medication Act; HR 3921/S 1827, KIDS Act of 2017; HR 3271, Protecting Access to Diabetes Supplies Act of 2017; S. 870, Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017; Centers for Medicare and Medicaid Services (CMS) Proposed Rule for the 2019 Medicare Part D Plan Year, pharmacy provisions; S.2553 / H.R. 6144, Know the Lowest Price Act of 2018; S.2554 / H.R. 6143, Patient Right to Know Drug Prices Act; H.R. 5343, Prescription Transparency Act of 2018; H.R. 5958, Phair Pricing Act of 2018; CMS Call Letter for 2019 Medicare Part D and Medicare Advantage Plans

Client expense: $320,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Personnel Management (OPM), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

Issues related to pharmaceutical manufacturer and pharmacy contracting with respect to drug pricing. Regulatory and proposed legislative changes to Medicare Part D including non-interference, Direct and Indirect Remuneration (DIR), pharmacy networks, classes of clinical concern, mail-service pharmacy and safe harbors related to manufacturer rebates. Issues related to the management of Medicaid prescription drug benefits. Issues related to prescription drug abuse in Medicare and Medicaid. Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, implementation of the prescriber registration rules and definition of negotiated price. Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, e-prescribing, PBM disclosure requirements, specialty pharmacy, mail-service pharmacy, formulary transparency, and medical loss ratio). Issues related to Medicaid Provider Enrollment. Issues related to the Medicare Coverage Gap Discount. H.R.1038/S.413, Improving Transparency and Accuracy in Part D Spending Act H.R.1316, Prescription Drug Price Transparency Act S.637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 S.771, Improving Access to Affordable Prescription Drug ActH.R.1939/S.1044, Ensuring Seniors Access to Local Pharmacies ActH.R.3528/S.2460, The Every Prescription Carried Safely Act S.2553/H.R.6144, Know the Lowest Price Act of 2018 S.2554/H.R.6143, Patient Right to Know Drug Prices Act H.R.4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 H.R.5958, Fair Pricing Act of 2018 H.R.5343, Prescription Transparency Act of 2018

Client expense: $766,889 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE

H.R. 1316-The Prescription Drug Price Transparency Act (MAC); H.R. 1038 & S.413-Improving Transparency and Accuracy in Medicare Part D Drug Spending Act (DIR); H.R. 1939 & S. 1044 - Ensuring Seniors Access to Local Pharmacies Act of 2017; S. 2553-Know the Lowest Price Act. CY2019 Medicare Part D Final Rule relating to direct and indirect renumeration fees; H.R.5958-The Phair Pricing Act of 2018.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.1939/S.1044: Ensuring Seniors Access to Local Pharmacies Act of 2017 (any willing pharmacy bill)--Provisions limiting payers' ability to selectively contract. S.2460/H.R.3528: Every Prescription Conveyed Securely Act--provisions requiring electronic prescribing of controlled substances in Medicare Part D; provisions added through amendment to H.R. 6 that limit who can use analgesic prescribing guidelines. S.2554: "Patient Right to Know Drug Prices Act,"--provisions to prohibit the use of gag clauses or require that beneficiaries be charged lower prices. H.R.5343: "Prescription Transparency Act of 2018,"-- provisions to prohibit the use of gag clauses or require that beneficiaries be charged lower prices. H.R.5958: The Phair Pricing Act of 2018, provisions related to the use of quality provisions and provisions to prohibit the use of gag clauses or require that beneficiaries be charged lower prices. H.R.6144: Know the Lowest Price Act -provisions to prohibit the use of gag clauses or require that beneficiaries be charged lower prices. Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, provisions affecting market competition for prescription drugs and the drug supply chain. H.R.5675: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries; provisions mandating a Medicare lock-in program for Medicare beneficiaries at risk for opioid abuse.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation to address abuses of the REMS program to allow generic drugs to come to market faster. H.R.2212/S.974: CREATES Act--provisions related to removing barriers to generic competition. H.R.1939/S.1044: Ensuring Seniors Access to Local Pharmacies Act of 2017 (any willing pharmacy bill)--provisions limiting payers' ability to selectively contract. H.R.1316: The Prescription Drug Price Transparency Act--issues related to ensuring the continuity of MAC pricing. S.2460/H.R.3528: Every Prescription Conveyed Securely Act--provisions requiring electronic prescribing of controlled substances in Medicare Part D; provisions added through amendment to H.R. 6 that limit who can use analgesic prescribing guidelines. S.2554: "Patient Right to Know Drug Prices Act,"--provisions to prohibit the use of gag clauses or require that beneficiaries be charged lower prices. H.R.5343: "Prescription Transparency Act of 2018,"-- provisions to prohibit the use of gag clauses or require that beneficiaries be charged lower prices. H.R.5958: The Phair Pricing Act of 2018, provisions related to the use of quality provisions and provisions to prohibit the use of gag clauses or require that beneficiaries be charged lower prices. H.R.6144: Know the Lowest Price Act -provisions to prohibit the use of gag clauses or require that beneficiaries be charged lower prices. Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, provisions affecting market competition for prescription drugs and the drug supply chain. H.R.5675: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries Provisions mandating a Medicare lock-in program for Medicare beneficiaries at risk for opioid abuse.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.413/H.R.1038: Improving Transparency and Accuracy in Medicare Part D Spending Act--provisions restricting payer quality payment programs in Medicare Part D. S.771/H.R.1776: Improving Access to Affordable Prescription Drugs Act--issues related to ensuring a competitive marketplace for prescription drugs. H.R.1939/S.1044, Ensuring Seniors Access to Local Pharmacies Act of 2017 (any willing pharmacy bill)--provisions limiting payers' ability to selectively contract. H.R.1316: The Prescription Drug Price Transparency Act--issues related to ensuring the continuity of MAC pricing. S.2460/H.R.3528: Every Prescription Conveyed Securely Act--provisions requiring electronic prescribing of controlled substances in Medicare Part D; provisions added through amendment to H.R. 6 that limit who can use analgesic prescribing guidelines. Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program Proposed Rule & Request for Information --Provisions on Part D. H.R.5343: "Prescription Transparency Act of 2018,"-- provisions to prohibit the use of gag clauses or require that beneficiaries be charged lower prices. S.2553: "Know the Lowest Price Act," --"-- provisions to prohibit the use of gag clauses or require that beneficiaries be charged lower prices. H.R.5958: The Phair Pricing Act of 2018, provisions related to the use of quality provisions and provisions to prohibit the use of gag clauses or require that beneficiaries be charged lower prices. H.R.6144: Know the Lowest Price Act -provisions to prohibit the use of gag clauses or require that beneficiaries be charged lower prices. Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, provisions affecting market competition for prescription drugs and the drug supply chain. H.R.5675: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries Provisions mandating a Medicare lock-in program for Medicare beneficiaries at risk for opioid abuse. CMS Proposed and Final Policy Changes and Updates for Medicare Advantage and the Prescription Drug Benefit Program for Contract Year 2019 (CMS-4182-P), provisions in a Request for Information related to rebates at the point-of-sale and pharmacist direct and indirect renumeration.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Stopping the application of the sequester cut (current and new) to Medicare Part B drug reimbursement (no bill). Fixing the 340B drug discount program, including PAUSE Act (H.R. 4710), HELP Act (S. 2312, and Ensuring the Value of the 340B Program Act (S. 2453) and other legislation in progress. Fixing Medicare Part B drug reimbursement by eliminating the manufacturer-to-wholesaler prompt pay discount from the calculation of average sales price, the basis of Part B drug reimbursement (H.R. 1920, S. 1304). Moving Medicare Part B to Part D (no bill). Misc. issues dealing with pharmacy benefit managers and patient and pharmacy abuses (includes bills H.R 1316 - Prescription Drug Price Transparency Act; H.R.1038 - Improving Transparency and Accuracy in Medicare Part D Spending Act; and H.R. 5958 - Phair Pricing Act of 2018}. Oncology Care Model (CMS/CMMI; no bill). Drug pricing/costs (no bill). VA clawback of payments made to community oncology practices for treating veterans out of network.

Client expense: $158,500 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)

H.R. 1316-The Prescription Drug Price Transparency Act (MAC); H.R. 1038 & S.413-Improving Transparency and Accuracy in Medicare Part D Drug Spending Act (DIR); H.R. 1939 & S. 1044 - Ensuring Seniors Access to Local Pharmacies Act of 2017; S. 2553-Know the Lowest Price Act. CY2019 Medicare Part D Final Rule relating to direct and indirect renumeration fees; H.R.5958-The Phair Pricing Act of 2018.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Direct and Indirect Remuneration; Drug Pricing Issues; HR 5958, PHAIR Pricing Act.

Client expense: Not reported · Firm income: $80,000

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