Medicare Prescription Drug Savings and Choice Act of 2015

Medicare Privatization. (No bill.) Proposals to transform traditional Medicare to a private insurance carrier program. Medicare Benefit Redesign. (No bill.) Proposals pertaining to Parts A and B deductibles; premiums, including means-testing; a catastrophic cap on out-of-pocket spending; the eligibility age; and proposals to privatize Medicare. Medicare Eligibility Age. (No bill.) Proposals to raise the eligibility age for Medicare from 65 to 67. Medicare Drug Savings. S. 1083, H.R. 2005, the Medicare Drug Savings Act: proposals to extend the application of Medicaid drug rebates to prescription drugs paid for by Medicare and used by Medicare-Medicaid eligible beneficiaries (dual-eligibles), and by people receiving the Medicare Part D Low-Income Subsidy. Medicare Prescription Drug Price Negotiation. H.R. 3061, S. 31, the Medicare Prescription Drug Price Negotiation Act of 2015: proposals to authorize the Secretary of the Department of Health and Human Services to negotiate discounts, rebates, and other price concessions to lower the cost paid by Medicare to pharmaceutical manufacturers. Medicare Prescription Drug Price Negotiation. H.R. 4207, Medicare Fair Drug Pricing Act of 2015: proposal to allow the Secretary of HHS to negotiate prices with manufacturers where little or no competition exists for drugs. Medicare Prescription Drug Plan Option. H.R. 3261, S. 1884, the Medicare Prescription Drug Savings and Choice Act of 2015: proposals to create one or more Medicare-administered drug plans with uniform premiums, providing seniors with the opportunity to purchase drugs directly through the Medicare program; requires the federal government to use its purchasing power to negotiate lower prices on prescription drugs for beneficiaries who enroll in the Medicare-administered plan. Medicare Home Health Benefits. (No bill.) Proposals pertaining to copayments for beneficiaries receiving the Medicare home health benefit. Medicare Observation Status. S. 843, H.R. 1571, Improving Access to Medicare Coverage Act of 2015: proposal to count days in the hospital in observation status toward meeting the three-day prior hospitalization requirement for skilled nursing facility (SNF) care eligibility. Comprehensive Health Care Reform. P.L. 111-148, Patient Protection and Affordable Care Act; P.L. 111-152, Health Care and Education Reconciliation Act of 2010: implementation of provisions reducing Medicare Advantage plan payments; requiring higher income Medicare beneficiaries to pay an increased share of Medicare Parts B and D premium costs; expanding benefits for low-income beneficiaries under the Medicare Savings Programs and the Part D Low-Income Subsidy (LIS); expanding coverage of prevention services; testing payment and delivery system reforms; and providing expanded Medicaid coverage. Patent Reform. S. 1137, Patent Act; H.R. 9, Innovation Act: proposal to carve brand-named pharmaceutical manufacturers out of an expedited United States Patent and Trademark Office (USPTO) review process that allows generic companies to bypass costly litigation when challenging drug patents. Expanding Drug Monopolies. H.R. 6, 21st Century Cures Act: proposal to extend orphan drug market exclusivity for existing drugs to new indications. Reducing Prescription Drug Costs. S. 2023, H.R. 3513, Prescription Drug Affordability Act: proposals to allow Medicare to negotiate drug prices, to allow Medicare and Medicaid to receive additional rebates from brand and generic drugs, and to allow for the re-importation of drugs from Canada. Reducing the cost of biologics. H.R. 5573, S. 3094, Price, Innovation and Competition for Essential Drugs (PRICED) Act: proposal to reduce the marketing exclusivity period for biologics from 12 to 7 years. Drug payment under Medicare Part B. H.R. 5122, to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models: proposal to prohibit implementation of a proposed demonstration testing new ways of paying physicians for drugs in order to eliminate incentives to unnecessarily prescribe high cost drugs. Medicare Fraud. H.R. 5340, Fighting Medicare Fraud Act: Legislation to close off a loophole allowing Medicare fraud offenders to evade enforcement authority when they move to a new company. Out-of-pocket drug costs. S.2864, RXCAP Act of 2016: proposal to cap out-of-pocket costs for Part D enrollees. Chronic Care Coordination. (No bill.) Proposals to facilitate the delivery of high-quality care for people with Medicare living with multiple chronic conditions. Medicare Vision, Dental and Hearing Coverage. H.R. 3308, Seniors Have Eyes, Ears and Teeth Act; H.R. 5396, the Medicare Dental, Vision, and Hearing Benefit Act of 2016: proposals to provide Medicare coverage for vision, hearing and dental services. Medicare Hearing Coverage. H.R. 1653, the Medicare Hearing Aid Coverage Act of 2015; H.R. 2748, the Help Extend Auditory Relief (HEAR) Act of 2015: proposals to provide Medicare coverage for the cost of hearing aids and examinations, to amend Medicare to cover aural rehabilitation services, hearing aids, audiology rehabilitation services, and related hearing services. Medicare Dental Coverage. S. 570, H.R. 1055, the Comprehensive Dental Reform Act: proposal to extend comprehensive dental coverage to all Medicare, Medicaid, and VA beneficiaries. Medicare Care Planning. S. 1549, the Care Planning Act of 2015: proposals to create a Medicare benefit for care planning, the coordination of services, to fill gaps in quality measurement in the advanced illness field. Medicare Private Plan Notification Improvements. (No bill.) Proposals to improve the annual notification Medicare private plans promulgate to Parts C and D enrollees pertaining to plan changes that will raise enrollee costs or limit access to products and services. Medicare Part B Payment Reforms. H.R. 5122: proposals to change the way Medicare pays doctors for administering drugs to eliminate incentives to prescribe drugs based on their expense instead of clinical need. Medicare Advantage Payment Reforms. (No bill.) Proposals to eliminate discrepancies in how much Medicare pays for services for similarly situated individuals in traditional Medicare and in Medicare Advantage plans. Medicare Access and CHIP Reauthorization Act. (Public Law 114-10). Comments to CMS/HHS proposing ways the proposed rule can be strengthened to ensure the new Quality Payment Program delivers on the promise of health system transformation. Medicaid Expansion. H.R. 4588 and S. 2787: proposal to provide a higher level of federal Medicaid funding for states that did not choose to expand Medicaid when the Affordable Care Act (ACA) first launched Medicaid expansion in 2014.

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

Government targets: Administration on Aging, Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Office of Management & Budget (OMB), President of the U.S., SENATE, Social Security Administration (SSA), Treasury, Dept of, Vice President of the U.S.

Medicare Program; Part B Drug Payment Model, Proposed rule, CMS-1670-P (March 8, 2016) - Provisions related to the Medicare Part B Drug Payment Model Medicaid Program: Covered Outpatient Drugs (CMS-2345-FC) - Provisions related to line extension drug definition, effective date and other issues S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 275: Medicare Home Infusion Site of Care Act of 2015 - Provisions related to Medicare coverage S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act of 2015 - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program S. 1884: Medicare Prescription Drug Savings and Choice Act of 2015 - Provisions related to the Medicare Operated Prescription Drug Plan Option S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures S. 2409: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to outpatient reimbursement rates S. 2646: Veterans Choice Improvement Act of 2016 - Provisions related to TRICARE drug pricing H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry HR. 512 - the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions related to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 4273: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to outpatient reimbursement rates Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed rules [CMS-2390-P] - Provisions related to Medicaid Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P) Proposed Medicare physician fee schedule (MPFS) rule for 2016 (CMS-1631-P) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) policy issues Medicare Part D rebates policy issues Drug cost and pricing policy issues Transparency policy issues Medication adherence policy issues Alternative payment models policy issues Value-based arrangements policy issues Coding and reimbursement policy issues including for biologics Center for Medicare and Medicaid Innovation (CMMI) transparency policy issues Chronic Care Working Group - Medicare policy affecting drugs

Medicare Program; Part B Drug Payment Model, Proposed rule, CMS-1670-P (March 8, 2016) - Provisions related to the Medicare Part B Drug Payment Model Medicaid Program: Covered Outpatient Drugs (CMS-2345-FC) - Provisions related to line extension drug definition, effective date and other issues S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 275: Medicare Home Infusion Site of Care Act of 2015 - Provisions related to Medicare coverage S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act of 2015 - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program S. 1884: Medicare Prescription Drug Savings and Choice Act of 2015 - Provisions related to the Medicare Operated Prescription Drug Plan Option S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures S. 2409: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to outpatient reimbursement rates S. 2646: Veterans Choice Improvement Act of 2016 - Provisions related to TRICARE drug pricing H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions related to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 4273: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to outpatient reimbursement rates Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed rules [CMS-2390-P] - Provisions related to Medicaid Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P) Proposed Medicare physician fee schedule (MPFS) rule for 2016 (CMS-1631-P) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) policy issues Medicare Part D rebates policy issues Drug cost and pricing policy issues Transparency policy issues Medication adherence policy issues Alternative payment models policy issues Value-based arrangements policy issues Coding and reimbursement policy issues including for biologics Center for Medicare and Medicaid Innovation (CMMI) transparency policy issues Chronic Care Working Group - Medicare policy affecting drugs

Policies to enhance patient access to medicines in Medicaid; Policies to enhance patient access to medicines in Medicare; H.R. 3061 & S. 31, Medicare Prescription Drug Price Negotiation Act of 2015; H.R. 1102 & S. 117, Medicare Prescription Drug Price Negotiation Act; H.R. 2005 & S. 1083, Medicare Drug Savings Act; H.R. 3261 & S. 1884, Medicare Prescription Drug Savings and Choice Act of 2015; Medicare payment proposals;

Client expense: $2,570,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Policies to enhance patient access to medicines in Medicaid; Policies to enhance patient access to medicines in Medicare; H.R. 3061 & S. 31, Medicare Prescription Drug Price Negotiation Act of 2015; H.R. 1102 & S. 117, Medicare Prescription Drug Price Negotiation Act; H.R. 2005 & S. 1083, Medicare Drug Savings Act; H.R. 3261 & S. 1884, Medicare Prescription Drug Savings and Choice Act of 2015; Medicare payment proposals;

Client expense: $2,630,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Medicare Privatization. (No bill.) Proposals to transform traditional Medicare to a private insurance carrier program. Medicare Benefit Redesign. (No bill.) Proposals pertaining to Parts A and B deductibles; premiums, including means-testing; a catastrophic cap on out-of-pocket spending; the eligibility age; and proposals to privatize Medicare. Medicare Eligibility Age. (No bill.) Proposals to raise the eligibility age for Medicare from 65 to 67. Medicare Drug Savings. S. 1083, H.R. 2005, the Medicare Drug Savings Act: proposals to extend the application of Medicaid drug rebates to prescription drugs paid for by Medicare and used by Medicare-Medicaid eligible beneficiaries (dual-eligibles), and by people receiving the Medicare Part D Low-Income Subsidy. Medicare Prescription Drug Price Negotiation. H.R. 3061, S. 31, the Medicare Prescription Drug Price Negotiation Act of 2015: proposals to authorize the Secretary of the Department of Health and Human Services to negotiate discounts, rebates, and other price concessions to lower the cost paid by Medicare to pharmaceutical manufacturers. Medicare Prescription Drug Price Negotiation. H.R. 4207, Medicare Fair Drug Pricing Act of 2015: proposal to allow the Secretary of HHS to negotiate prices with manufacturers where little or no competition exists for drugs. Medicare Prescription Drug Plan Option. H.R. 3261, S. 1884, the Medicare Prescription Drug Savings and Choice Act of 2015: proposals to create one or more Medicare-administered drug plans with uniform premiums, providing seniors with the opportunity to purchase drugs directly through the Medicare program; requires the federal government to use its purchasing power to negotiate lower prices on prescription drugs for beneficiaries who enroll in the Medicare-administered plan. Medicare Home Health Benefits. (No bill.) Proposals pertaining to copayments for beneficiaries receiving the Medicare home health benefit. Medicare Observation Status. S. 843, H.R. 1571, Improving Access to Medicare Coverage Act of 2015: proposal to count days in the hospital in observation status toward meeting the three-day prior hospitalization requirement for skilled nursing facility (SNF) care eligibility. Comprehensive Health Care Reform. P.L. 111-148, Patient Protection and Affordable Care Act; P.L. 111-152, Health Care and Education Reconciliation Act of 2010: implementation of provisions reducing Medicare Advantage plan payments; requiring higher income Medicare beneficiaries to pay an increased share of Medicare Parts B and D premium costs; expanding benefits for low-income beneficiaries under the Medicare Savings Programs and the Part D Low-Income Subsidy (LIS); expanding coverage of prevention services; testing payment and delivery system reforms; and providing expanded Medicaid coverage. Patent Reform. S. 1137, Patent Act; H.R. 9, Innovation Act: proposal to carve brand-named pharmaceutical manufacturers out of an expedited United States Patent and Trademark Office (USPTO) review process that allows generic companies to bypass costly litigation when challenging drug patents. Expanding Drug Monopolies. H.R. 6, 21st Century Cures Act: proposal to extend orphan drug market exclusivity for existing drugs to new indications. Reducing Prescription Drug Costs. S. 2023, H.R. 3513, Prescription Drug Affordability Act: proposals to allow Medicare to negotiate drug prices, to allow Medicare and Medicaid to receive additional rebates from brand and generic drugs, and to allow for the re-importation of drugs from Canada. Chronic Care Coordination. (No bill.) Proposals to facilitate the delivery of high-quality care for people with Medicare living with multiple chronic conditions. Medicare Vision, Dental and Hearing Coverage. H.R. 3308, Seniors Have Eyes, Ears and Teeth Act: proposal to provide Medicare coverage for vision, hearing and dental services. Medicare Hearing Coverage. H.R. 1653, the Medicare Hearing Aid Coverage Act of 2015: proposal to provide Medicare coverage for the cost of hearing aids and examinations. Medicare Dental Coverage. S. 570, H.R. 1055, the Comprehensive Dental Reform Act: proposal to extend comprehensive dental coverage to all Medicare, Medicaid, and VA beneficiaries. Medicare Part B Premium and Deductible Increase. S. 2148, Protecting Medicare Beneficiaries Act of 2015; H.R. 3696, Medicare Premium Fairness Act of 2015 and P.L. 114-74: proposals to prevent steep increases in Medicare Part B premiums and deductibles in 2016. Medicare Care Planning. S. 1549, the Care Planning Act of 2015: proposals to create a Medicare benefit for care planning, the coordination of services, to fill gaps in quality measurement in the advanced illness field, and to include advanced care planning information in the Medicare & You handbook. Medicare Private Plan Notification Improvements. (No bill.) Proposals to improve the annual notification Medicare private plans promulgate to Parts C and D enrollees pertaining to plan changes that will raise enrollee costs or limit access to products and services. Medicare Part B Payment Reforms. (No bill.) Proposals to change the way Medicare pays doctors for administering drugs to eliminate incentives to prescribe drugs based on their expense instead of clinical need. Medicare Advantage Payment Reforms. (No bill.) Proposals to eliminate discrepancies in how much Medicare pays for services for similarly situated individuals in traditional Medicare and in Medicare Advantage plans.

S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 275: Medicare Home Infusion Site of Care Act of 2015 - Provisions related to Medicare coverage S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program S. 1884: Medicare Prescription Drug Savings and Choice Act of 2015 - Provisions related to the Medicare Operated Prescription Drug Plan Option S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions relating to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 3819: Surface Transportation Extension Act of 2015 - Medicare related offsets to the biopharmaceutical industry H.R. __, S. __: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to Hospital Outpatient Department (HOPD) reimbursement rates Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to Medicaid Medicaid Program; Covered Outpatient Drugs; Proposed Rule [CMS-2345-F] - Provisions related to calculating Average Manufacturer Price (AMP) Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P) Proposed Medicare physician fee schedule (MPFS) rule for 2016 (CMS-1631-P) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) policy issues Medicare Part D rebates policy issues Drug cost and pricing policy issues Transparency policy issues Medication adherence policy issues Alternative payment models policy issues Chronic Care Working Group - Medicare policy affecting drugs HR. 512 - the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014

H.R. 2, Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10); Monitor implementation, P.L. 114-10; Monitor implementation of the Patient Protection and Affordable Care Act, P.L. 111-148; Extend Section 3111, P.L. 111-148; H.R. 1416, Cancer Patient Protection Act of 2015; H.R. 775 / S. 539, Medicare Access to Rehabilitation Services Act of 2015; H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015; H.R. 3261 / S. 1884 Medicare Prescription Drug Savings and Choice Act of 2015; H.R. 4227 / S. 2392, Medicare Advantage Bill of Rights.

Client expense: $110,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 275: Medicare Home Infusion Site of Care Act of 2015 - Provisions related to Medicare coverage S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program S. 1884: Medicare Prescription Drug Savings and Choice Act of 2015 - Provisions related to the Medicare Operated Prescription Drug Plan Option S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures S. 2409: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to outpatient reimbursement rates H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions related to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 3819: Surface Transportation Extension Act of 2015 - Medicare related offsets to the biopharmaceutical industry H.R. 4273: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to outpatient reimbursement rates Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed rules [CMS-2390-P] - Provisions related to Medicaid Medicaid Program; Covered Outpatient Drugs; Proposed rule [CMS-2345-F] - Provisions related to calculating Average Manufacturer Price (AMP) Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P) Proposed Medicare physician fee schedule (MPFS) rule for 2016 (CMS-1631-P) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) policy issues Medicare Part D rebates policy issues Drug cost and pricing policy issues Transparency policy issues Medication adherence policy issues Alternative payment models policy issues Chronic Care Working Group - Medicare policy affecting drugs

Medicare Privatization. (No bill.) Proposals to transform traditional Medicare to a private insurance carrier program. Medicare Benefit Redesign. (No bill.) Proposals pertaining to Parts A and B deductibles; premiums, including means-testing; a catastrophic cap on out-of-pocket spending; the eligibility age; and proposals to privatize Medicare. Medicare Drug Savings. S. 1083, H.R. 2005, the Medicare Drug Savings Act: proposals to extend the application of Medicaid drug rebates to prescription drugs paid for by Medicare and used by Medicare-Medicaid eligible beneficiaries (dual-eligibles), and by people receiving the Medicare Part D Low-Income Subsidy. Medicare Prescription Drug Price Negotiation. H.R. 3061, S. 31, the Medicare Prescription Drug Price Negotiation Act of 2015: proposals to authorize the Secretary of the Department of Health and Human Services to negotiate discounts, rebates, and other price concessions to lower the cost paid by Medicare to pharmaceutical manufacturers. Medicare Prescription Drug Price Negotiation. H.R. 4207, Medicare Fair Drug Pricing Act of 2015: proposal to allow the Secretary of HHS to negotiate prices with manufacturers where little or no competition exists for drugs. Medicare Prescription Drug Plan Option. H.R. 3261, S. 1884, the Medicare Prescription Drug Savings and Choice Act of 2015: proposals to create one or more Medicare-administered drug plans with uniform premiums, providing seniors with the opportunity to purchase drugs directly through the Medicare program; requires the federal government to use its purchasing power to negotiate lower prices on prescription drugs for beneficiaries who enroll in the Medicare-administered plan. Medicare Home Health Benefits. (No bill.) Proposals pertaining to copayments for beneficiaries receiving the Medicare home health benefit. Medicare Observation Status. S. 843, H.R. 1571, Improving Access to Medicare Coverage Act of 2015: proposal to count days in the hospital in observation status toward meeting the three-day prior hospitalization requirement for skilled nursing facility (SNF) care eligibility. Comprehensive Health Care Reform. P.L. 111-148, Patient Protection and Affordable Care Act; P.L. 111-152, Health Care and Education Reconciliation Act of 2010: implementation of provisions reducing Medicare Advantage plan payments; requiring higher income Medicare beneficiaries to pay an increased share of Medicare Parts B and D premium costs; expanding benefits for low-income beneficiaries under the Medicare Savings Programs and the Part D Low-Income Subsidy (LIS); expanding coverage of prevention services; testing payment and delivery system reforms; and providing expanded Medicaid coverage. Patent Reform. S. 1137, Patent Act; H.R. 9, Innovation Act: proposal to carve brand-named pharmaceutical manufacturers out of an expedited United States Patent and Trademark Office (USPTO) review process that allows generic companies to bypass costly litigation when challenging drug patents. Expanding Drug Monopolies. H.R. 6, 21st Century Cures Act: proposal to extend orphan drug market exclusivity for existing drugs to new indications. Reducing Prescription Drug Costs. S. 2023, H.R. 3513, Prescription Drug Affordability Act: proposals to allow Medicare to negotiate drug prices, to allow Medicare and Medicaid to receive additional rebates from brand and generic drugs, and to allow for the re-importation of drugs from Canada. Chronic Care Coordination. (No bill.) Proposals to facilitate the delivery of high-quality care for people with Medicare living with multiple chronic conditions. Medicare Vision, Dental and Hearing Coverage. H.R. 3308, Seniors Have Eyes, Ears and Teeth Act: proposal to provide Medicare coverage for vision, hearing and dental services. Medicare Hearing Coverage. H.R. 1653, the Medicare Hearing Aid Coverage Act of 2015: proposal to provide Medicare coverage for the cost of hearing aids and examinations. Medicare Dental Coverage. S. 570, H.R. 1055, the Comprehensive Dental Reform Act: proposal to extend comprehensive dental coverage to all Medicare, Medicaid, and VA beneficiaries. Medicare Part B Premium and Deductible Increase. S. 2148, Protecting Medicare Beneficiaries Act of 2015; H.R. 3696, Medicare Premium Fairness Act of 2015 and P.L. 114-74: proposals to prevent steep increases in Medicare Part B premiums and deductibles in 2016. Medicare Care Planning. S. 1549, the Care Planning Act of 2015: proposals to create a Medicare benefit for care planning, the coordination of services, to fill gaps in quality measurement in the advanced illness field, and to include advanced care planning information in the Medicare & You handbook. Medicare Private Plan Notification Improvements. (No bill.) Proposals to improve the annual notification Medicare private plans promulgate to Parts C and D enrollees pertaining to plan changes that will raise enrollee costs or limit access to products and services.

H.R. 2, Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10); Monitor implementation, P.L. 114-10; Monitor implementation, P.L. 111-148; Extend Section 3111, P.L. 111-148; H.R. 1416, Cancer Patient Protection Act of 2015; H.R. 775 / S. 539, Medicare Access to Rehabilitation Services Act of 2015; H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015; H.R. 3261 / S. 1884 Medicare Prescription Drug Savings and Choice Act of 2015

Client expense: $110,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Monitor implementation of the Patient Protection and Affordable Care Act. (P.L. 111-148). Monitor federal issues and legislation associated with health care policy. H.R. 2, Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). H.R. 6, House 21st Century Cures Act. H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R. 775, Medicare Access to Rehabilitation Services Act of 2015. S. 539, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 1416, Cancer Patient Protection Act of 2015. H.R. 1859, Ensuring Children's Access to Specialty Care Act of 2015. H.R. 2126, Cutting Costly Codes Act of 2015. H.R. 2247, ICD-TEN Act. H.R. 3020, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015. S. 1695, Senate Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015. S.1376, National Defense Authorization Act for Fiscal Year 2016. H.R. 3309, Flex-IT 2 Act. H.R. 3261, Medicare Prescription Drug Savings and Choice Act of 2015. S. 1884, Medicare Prescription Drug Savings and Choice Act of 2015.

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

Monitor implementation of the Patient Protection and Affordable Care Act. (P.L. 111-148). Monitor federal issues and legislation associated with health care policy. H.R. 2, Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). H.R. 6, House 21st Century Cures Act. H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R. 775, Medicare Access to Rehabilitation Services Act of 2015. S. 539, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 1416, Cancer Patient Protection Act of 2015. H.R. 1859, Ensuring Children's Access to Specialty Care Act of 2015. H.R. 2126, Cutting Costly Codes Act of 2015. H.R. 2247, ICD-TEN Act. H.R. 3020, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015. S. 1695, Senate Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015. S.1376, National Defense Authorization Act for Fiscal Year 2016. H.R. 3309, Flex-IT 2 Act. H.R. 3261, Medicare Prescription Drug Savings and Choice Act of 2015. S. 1884, Medicare Prescription Drug Savings and Choice Act of 2015.

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

S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program S. 1884: Medicare Prescription Drug Savings and Choice Act of 2015 - Provisions related to the Medicare Operated Prescription Drug Plan Option S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions relating to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 2570: Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 2581: Preservation of Access for Seniors in Medicare Advantage Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 3244: Providing Innovative Care for Complex Cases Demonstration Act of 2015 - Provisions relating to changes to the Part D benefit Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to Medicaid Medicaid Program; Covered Outpatient Drugs; Final Rule [CMS-2345-F] - Provisions related to calculating Average Manufacturer Price (AMP) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Medicare Part D rebates issues Drug cost and pricing issues Medication adherence policy issues Alternative payment models policy issues

Policies to enhance patient access to medicines in Medicaid; Policies to enhance patient access to medicines in Medicare; H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act; H.R. 3061 & S. 31, Medicare Prescription Drug Price Negotiation Act of 2015; H.R. 3261 & S. 1884, Medicare Prescription Drug Savings and Choice Act of 2015; H.R. 3261 & S. 1884, Medicare Prescription Drug Savings and Choice Act of 2015; S. 2023, Prescription Drug Affordability Act of 2015 Medicare payment proposals;

Client expense: $1,240,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Medicare Privatization. (No bill.) Proposals to transform traditional Medicare to a private insurance carrier program. Medicare Benefit Redesign. (No bill.) Proposals pertaining to Parts A and B deductibles; premiums, including means-testing; a catastrophic cap on out-of-pocket spending; the eligibility age; and proposals to privatize Medicare. Medicare Drug Savings. S. 1083, H.R. 2005, the Medicare Drug Savings Act: proposals to extend the application of Medicaid drug rebates to prescription drugs paid for by Medicare and used by Medicare-Medicaid eligible beneficiaries (dual-eligibles), and by people receiving the Medicare Part D Low-Income Subsidy. Medicare Prescription Drug Price Negotiation. H.R. 3061, S. 31, the Medicare Prescription Drug Price Negotiation Act of 2015: proposals to authorize the Secretary of the Department of Health and Human Services to negotiate discounts, rebates, and other price concessions to lower the cost paid by Medicare to pharmaceutical manufacturers. Medicare Prescription Drug Plan Option. H.R. 3261, S. 1884, the Medicare Prescription Drug Savings and Choice Act of 2015: proposals to create one or more Medicare-administered drug plans with uniform premiums, providing seniors with the opportunity to purchase drugs directly through the Medicare program; requires the federal government to use its purchasing power to negotiate lower prices on prescription drugs for beneficiaries who enroll in the Medicare-administered plan. Medicare Home Health Benefits. (No bill.) Proposals pertaining to copayments for beneficiaries receiving the Medicare home health benefit. Medicare Observation Status. S. 843, H.R. 1571, Improving Access to Medicare Coverage Act of 2015: proposal to count days in the hospital in observation status toward meeting the three-day prior hospitalization requirement for skilled nursing facility (SNF) care eligibility. Comprehensive Health Care Reform. P.L. 111-148, Patient Protection and Affordable Care Act; P.L. 111-152, Health Care and Education Reconciliation Act of 2010: implementation of provisions reducing Medicare Advantage plan payments; requiring higher income Medicare beneficiaries to pay an increased share of Medicare Parts B and D premium costs; expanding benefits for low-income beneficiaries under the Medicare Savings Programs and the Part D Low-Income Subsidy (LIS); expanding coverage of prevention services; testing payment and delivery system reforms; and providing expanded Medicaid coverage. Patent Reform. S. 1137, Patent Act; H.R.9, Innovation Act: proposals to omit brand manufacturers from the U.S. Patent Office expedited review process intended to allow generic manufacturers to bypass costly litigation when challenging drug patents. Expanding Drug Monopolies. H.R. 6, 21st Century Cures Act: proposal to extend orphan drug market exclusivity for existing drugs to new indications. Reducing Prescription Drug Costs. S. 2023, H.R. 3513, Prescription Drug Affordability Act: proposals to allow Medicare to negotiate drug prices, to allow Medicare and Medicaid to receive additional rebates from brand and generic drugs, and to allow for the re-importation of drugs from Canada. Chronic Care Coordination. (No bill.) Proposals to facilitate the delivery of high-quality care for people with Medicare living with multiple chronic conditions. Medicare Vision, Dental and Hearing Coverage. H.R. 3308, Seniors Have Eyes, Ears and Teeth Act: proposal to provide Medicare coverage for vision, hearing and dental services. Medicare Hearing Coverage. H.R. 1653, the Medicare Hearing Aid Coverage Act of 2015: proposal to provide Medicare coverage for the cost of hearing aids and examinations. Medicare Dental Coverage. S. 570, H.R. 1055, the Comprehensive Dental Reform Act: proposal to extend comprehensive dental coverage to all Medicare, Medicaid, and VA beneficiaries. Medicare Part B Premium and Deductible Increase. S. 2148, Protecting Medicare Beneficiaries Act of 2015; H.R. 3696, Medicare Premium Fairness Act of 2015: proposals to prevent steep increases in Medicare Part B premiums and deductibles in 2016.