PRICED Act

Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor federal and legislative activity related to Medicare Reimbursement. Monitor federal issues and legislation associated with health care policy. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). H.R. 34, 21st Century Cures Act (P.L. 114-255) H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R.775, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 3309, Flex-IT 2 Act. H.R. 4227, Medicare Advantage Bill of Rights. H.R. 4848, HIP Act. H.R. 4909, National Defense Authorization Act for Fiscal Year 2017. H.R. 5001, Flexibility in Electronic Health Record Reporting Act. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. H.R. 5293, Department of Defense Appropriations, FY 2017. H.R. 5652, Access to Better Care Act of 2016 H.R. 5573, PRICED Act H.R. 5926, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S.539, Medicare Access to Rehabilitation Services Act of 2015. S. 2392, Medicare Advantage Bill of Rights. S. 2511, Improving Health Information Technology Act. S. 2822, Flexibility in Electronic Health Record Reporting Act S. 2943, National Defense Authorization Act for Fiscal Year 2017 S. 3000, Department of Defense Appropriations, FY 2017. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S. 3094, PRICED Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.3094 , H.R.5573-Price Relief, Innovation, and Competition for Essential Drugs Act (PRICED)

Client expense: $2,080,000 · Firm income: Not reported

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

H.R.6 - Discussed the House Energy and Commerce Committee 21st Century Cures Initiative and Senate HELP Committee efforts focused on drug and medical device innovation issues. S. 31, H.R. 3061 - Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. S. 2019 - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. S. 3094, H.R. 5573 - Discussed legislation to reduce the market exclusivity period for biologic drugs. Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. S. 3335, H.R. 6043 - Discussed the need for price transparency on prescription drug prices and comparativeness effectiveness research. Discussed legislation to address the opioid abuse epidemic including fraud and abuse provisions. Discussed opioid issues generally. S. 3056 - Discussed legislation to address abuse of Risk-Evaluation and Mitigation Strategies (REMS) by brand name drug companies to block lower-cost generic drugs from entering the market. S. 3455 - Discussed legislation to allow temporary importation authority in cases of drug shortages and non-competitive markets. S. 2956, H.R. 5054, H.R. 5325, H.R. 2028, Agriculture Appropriations, FY2017 - Lobbied in support of FDA funding. H.R. 6043, FAIR Drug Pricing Act - Supported bill to require manufactures of certain drugs and biological products to report to HHS price increases that result in a 10% or more increase in the price of a drug over a 12 month period.

Client expense: $2,530,000 · Firm income: Not reported

S. 632, STRONG Patents Act of 2015; S. 2733, Venue Equity and Non-Uniformity Elimination Act of 2016; H.R. 5573 & S. 3094, Price Relief, Innovation, and Competition for Essential Drugs (PRICED) Act; S. 3056, CREATES Act of 2016; Proposals/Initiatives related to international intellectual property protection;

Client expense: $1,040,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

S. 314 - Pharmacy and Medically Underserved Areas Enhancement Act H.R. 592 - Pharmacy and Medically Underserved Areas Enhancement Act H.R. 1270 - Restoring Access to Medication Act of 2015 S. 709 - Restoring Access to Medication Act of 2015 S.776 - Medication Therapy Management Empowerment Act of 2015 H.R. 793 - Ensuring Seniors Access to Pharmacies Act of 2015 H.R. 1021, the Protecting the Integrity of Medicare Act (PIMA) of 2015 H.R.2 - Medicare Access and CHIP Reauthorization Act of 2015 H.R.6 - 21st Century Cures Act S.1190 - Ensuring Seniors Access to Local Pharmacies Act of 2015 S. 1913 - Stopping Medication Abuse and Protecting Seniors Act of 2015 H.R.4878 - Better Care, Lower Cost Act S. 3094 - Price Relief, Innovation, and Competition for Essential Drugs Act HR 5573 - Price Relief, Innovation and Competition for Essential Drugs Act H. R. 4641 -To provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes. HR 5210-Patient Access to Durable Medical Equipment Act S 2736-Patient Access to Durable Medical Equipment Act of 2016 H.R. 1192 - National Diabetes Clinical Care Commission Act S. 3056 - Creating and Restoring Equal Access to Equivalent Samples Act H.R. 5951- Improving Transparency and Accuracy in Medicare Part B Spending

Client expense: $380,000 · Firm income: Not reported

Medicare Part B Premium. (No bill.) Proposals to mitigate the expected increase in the 2017 Part B premium for beneficiaries not protected by the "hold harmless" provision. Medicare Part B Enrollment. Comments on the CMS/HHS Proposed Notice of Benefit and Payment Parameters for 2018. Medicare Supplemental Insurance. H.R. 6265, the Medigap Consumer Protection Act of 2016: proposal to improve access to and improve beneficiary information about Medigap for seniors and disabled individuals in the traditional Medicare program. Medicare Affordability. S. 3371, H.R. 6109, Medicare Affordability and Enrollment Act of 2016: proposals to improve Medicare for beneficiaries by capping out-of-pocket costs in traditional Medicare; increasing financial assistance for low-income beneficiaries; aligning the Medicare Savings Programs and Low-Income Subsidy; eliminating the 24- month waiting period for Medicare coverage for people receiving Social Security Disability Insurance benefits; making changes in the enrollment period for Medicare; eliminating gaps between enrollment and when actual coverage begins; limiting the Part B late enrollment penalty; and providing permanent funding for the State Health Insurance Assistance Programs (SHIPs), Area Agencies on Aging (AAAs), Aging and Disability Resource Centers ADRCs) and the National Center for Benefits Outreach and Enrollment. Medicare Part B Enrollment. S. 3236, H.R. 5772, the Beneficiary Enrollment Notification and Eligibility Simplification (BENES) Act: legislation to modernize and simplify Part B enrollment. 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 of 2015: proposal to expand Medicare coverage to include dental care. Medicare Dental, Vision, and Hearing Coverage. H.R. 5396, H.R. 3308: Proposals to expand Medicare coverage to include comprehensive coverage of dental, vision, and hearing care. Home-based Primary Medical Care. S. 3130, Independence at Home Act of 2016: legislation to expand the Independence at Home Medicare demonstration project providing home-based primary medical care to elders with severe chronic illness and disability. Continuous Glucose Monitoring Devices. S. 804, Medicare CGM Access Act: legislation to provide Medicare coverage of continuous glucose monitoring (CGM) devices for beneficiaries with diabetes who meet specified medical criteria. Biologics Market Exclusivity Period. S. 3094, H.R. 5573, Price Relief, Innovation and Competition for Essential Drugs (PRICED) Act: legislation to reduce the market exclusivity period for biologics from its current 12 years to seven years. Drug Manufacture Transparency. S. 3335, H.R. 6043, Fair Accountability and Innovative Research Drug Pricing Act of 2016: proposal to require drug manufacturers to be more transparent about justification for increases in drug prices over ten percent, namely to report their spending on a drug's research and development as well as their profits on a drug each year since its approval. Drug Importation. H.R. 2623, the Personal Drug Importation Fairness Act: proposal to establish policies for the safe reimportation of pharmaceutical drugs by individuals for their personal use. Containment of Prescription Drug Costs. S. 2023, the Prescription Drug Affordability Act: proposals to require Medicare to negotiate drug prices under the Medicare Part D prescription drug program; allow for importation of prescription drugs from licensed Canadian pharmacies; require manufacturers to provide a rebate to the federal government for drugs covered under Medicare Part D for low-income Medicare beneficiaries; require generic drug manufacturers to pay an additional rebate to Medicaid if their drug prices rise faster than inflation; close the Medicare Part D donut hole for brand and generic drugs by 2017; and prohibit anti-competitive pay-for-delay arrangements between brand and generic drug makers. Medicare Prescription Drug Negotiation Authority. H.R. 4207, Medicare Fair Drug Pricing Act: proposal to allow the Secretary of Health and Human Services (HHS) to negotiate prices with pharmaceutical companies when drugs lack sufficient competition. 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. Medicare Privatization. (No bill.) Proposals to transform traditional Medicare to a private insurance carrier program. Medicare Eligibility Age. (No bill.) Proposals to raise the eligibility age for Medicare from 65 to 67. Medicaid Restructuring. (No bill.) Proposals to change Medicaid from an entitlement program to block grants or per capita caps, forms of lump sum payments from the federal government. Affordable Care Act (ACA) repeal. (No bill.) Proposals to repeal the ACA affecting the closing of the Medicare Part D donut hole, Medicare coverage of ACA-mandated preventive services, and payment and delivery reforms that extend the life of the Medicare Part A Trust Fund. Childrens Health Insurance Program (CHIP) extension. (No bill.) Proposal to add an extension of the Medicare therapy cap exceptions process.

H.R.6 - Discussed the House Energy and Commerce Committee 21st Century Cures Initiative and Senate HELP Committee efforts focused on drug and medical device innovation issues. S. 31, H.R. 3061 - Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. S. 2019 - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. S. 3094, H.R. 5573 - Discussed legislation to reduce the market exclusivity period for biologic drugs. Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. S. 3335, H.R. 6043 - Discussed the need for price transparency on prescription drug prices and comparativeness effectiveness research. Discussed legislation to address the opioid abuse epidemic including fraud and abuse provisions. Discussed opioid issues generally. S. 3056 - Discussed legislation to address abuse of Risk-Evaluation and Mitigation Strategies (REMS) by brand name drug companies to block lower-cost generic drugs from entering the market. S. 3455 - Discussed legislation to allow temporary importation authority in cases of drug shortages and non-competitive markets. S. 2956, H.R. 5054, H.R. 5325, Agriculture Appropriations, FY2017 - Lobbied in support of FDA funding. H.R. 6043, FAIR Drug Pricing Act - Supported bill to require manufactures of certain drugs and biological products to report to HHS price increases that result in a 10% or more increase in the price of a drug over a 12 month period.

Client expense: $2,290,000 · Firm income: Not reported

S.3094 , H.R.5573-Price Relief, Innovation, and Competition for Essential Drugs Act (PRICED)

Client expense: $1,320,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA)

H.R. 406 & S. 1767, Combination Drug Development Incentive Act of 2015; S. 1878, Advancing Hope Act of 2015; S. 632, STRONG Patents Act of 2015; H.R. 9, Innovation Act; S. 2733, Venue Equity and Non-Uniformity Elimination Act of 2016; H.R. 971 & S. 1421, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; H.R. 5573 & S. 3094, Price Relief, Innovation, and Competition for Essential Drugs (PRICED) Act; S. 3056, CREATES Act of 2016; Proposals/Initiatives related to international intellectual property protection;

Client expense: $1,920,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

S. 314 - Pharmacy and Medically Underserved Areas Enhancement Act H.R. 592 - Pharmacy and Medically Underserved Areas Enhancement Act H.R. 1270 - Restoring Access to Medication Act of 2015 S. 709 - Restoring Access to Medication Act of 2015 S.776 - Medication Therapy Management Empowerment Act of 2015 H.R. 793 - Ensuring Seniors Access to Pharmacies Act of 2015 H.R. 1021, the Protecting the Integrity of Medicare Act (PIMA) of 2015 H.R.2 - Medicare Access and CHIP Reauthorization Act of 2015 H.R.6 - 21st Century Cures Act S.1190 - Ensuring Seniors Access to Local Pharmacies Act of 2015 S. 1913 - Stopping Medication Abuse and Protecting Seniors Act of 2015 H.R.4878 - Better Care, Lower Cost Act S. 3094 - Price Relief, Innovation, and Competition for Essential Drugs Act HR 5573 - Price Relief, Innovation and Competition for Essential Drugs Act H. R. 4641 -To provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes. HR 5210-Patient Access to Durable Medical Equipment Act S 2736-Patient Access to Durable Medical Equipment Act of 2016 H.R. 1192 - National Diabetes Clinical Care Commission Act S. 3056 - Creating and Restoring Equal Access to Equivalent Samples Act H.R. 5951- Improving Transparency and Accuracy in Medicare Part B Spending

Client expense: $920,000 · Firm income: Not reported

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, grandfathering, e-prescribing, PBM disclosure requirements, specialty pharmacy, mail-service pharmacy, formulary transparency, and medical loss ratio). Regulatory and proposed legislative changes to Medicare part D including non-interference, pharmacy networks, classes of clinical concern, mail-service pharmacy, EGWP waivers, MTM expansion, long term care pharmacy, recovery audit contractors. Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs. Issues related to prescription drug abuse in Medicare. H.R.2: Medicare Access and CHIP Reauthorization Act of 2015 - provisions related to the expansion of availability of Medicare data H.R.244: The MAC Transparency Act H.R.793/S1190: The Ensuring Seniors Access to Local Pharmacies Act H.R.1021: The Protecting the Integrity of Medicare Act H.R.1600: The Patient Access to Treatments Act Provisions related to the 21st Century Cures Initiative (Energy and Commerce) and Innovations for Healthier Americans (HELP Committee). Issues related to the affordability of prescription drugs and competitive marketplace, including: pedigree, FDA user fees, manufacturer market and data exclusivity, REMS, biosimilars. H.R.804: The Access to Medicare Data Act H.R.2298: The Medicare Drug Abuse Prevention Act H.R.6: 21st Century Cures Act S.2700: The FDA and NIH Workforce Authorization Modernization Act - Provisions related to biologic drugs H.R.2841: The FAST Generics Act S.3056: The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016 H.R. 4784/S.2651: The Increasing Competition in Pharmaceuticals Act H.R. 5573/S.3094 The Price Relief, Innovation, and Competition for Essential Drugs Act or the PRICED Act

Medicare Part B Premium. (No bill.) Proposals to mitigate the expected increase in the 2017 Part B premium for beneficiaries not protected by the hold harmless provision. Medigap. H.R. 6265, the Medigap Consumer Protection Act of 2016: proposal to improve access to and improve beneficiary information about Medigap for seniors and disabled individuals in the traditional Medicare program. Medicare Affordability. S. 3371, H.R. 6109, Medicare Affordability and Enrollment Act of 2016: proposals to improve Medicare for beneficiaries by capping out-of-pocket costs in traditional Medicare; increasing financial assistance for low-income beneficiaries; aligning the Medicare Savings Programs and Low-Income Subsidy; eliminating the 24-month waiting period for Medicare coverage for people receiving Social Security Disability Insurance benefits; making commonsense changes in the enrollment period for Medicare; eliminating gaps between enrollment and when actual coverage begins; limiting the Part B late enrollment penalty; and providing permanent funding for the State Health Insurance Assistance Programs (SHIPs), Area Agencies on Aging (AAAs), Aging and Disability Resource Centers (ADRCs) and the National Center for Benefits Outreach and Enrollment. Medicare Part B Enrollment. S. 3236, H.R. 5772, the Beneficiary Enrollment Notification and Eligibility Simplification (BENES) Act: legislation to modernize and simplify Part B enrollment. Medicare Observation Status. Public Law 114-42, Notice of Observation Treatment and Implication for Care Eligibility Act (NOTICE Act): comments on the CMS/HHS proposed rule to strengthen protections for Medicare beneficiaries who are hospitalized in observation status. 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. Expanding Drug Monopolies. H.R. 6, 21st Century Cures Act. Proposal to extend orphan drug market exclusivity for existing drugs to new indications. Medicare Part B Drug Payments. H.R. 5122: legislation to prohibit the Department of Health and Human Services from taking any further action on a proposed rule to change how Medicare pays for certain drugs that are typically not self-administered (such as some intravenous medications and chemotherapy drugs). Drug Manufacture Transparency. S. 3335, H.R. 6043, Fair Accountability and Innovative Research Drug Pricing Act of 2016: proposal to require drug manufacturers to be more transparent about justification for increases in drug prices over ten percent, namely to report their spending on a drugs research and development as well as their profits on a drug each year since its approval. Biologics Market Exclusivity Period. S. 3094, H.R. 5573, Price Relief, Innovation and Competition for Essential Drugs (PRICED) Act: legislation to reduce the market exclusivity period for biologics from its current 12 years to seven years. Continuous Glucose Monitoring Devices. S. 804, Medicare CGM Access Act: legislation to provide Medicare coverage of continuous glucose monitoring (CGM) devices for beneficiaries with diabetes who meet specified medical criteria. Home-based Primary Medical Care. S. 3130, Independence at Home Act of 2016: legislation to expand the Independence at Home Medicare demonstration project providing home-based primary medical care to elders with severe chronic illness and disability. Alzheimers Beneficiary and Caregiver Assistance. S. 3137, H.R. 5681, Alzheimers Beneficiary and Caregiver Support Act: proposals to improve the quality of life for people living with Alzheimers disease and other forms of dementia, support family care partners, and reduce costs to federal and state health programs. Alzheimers Caregiver Support. S. 3113, H.R. 3039, Alzheimers Caregiver Support Act: legislation to provide vital support and training to people living with Alzheimers disease and other forms of dementia and to their caregivers. Medicare Payment Policy. Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017 (CMS-16545-P): comments to CMS/HHS pertaining to the proposed rule for Sec. II. E. 5, Assessment and Care Planning for Patients with Cognitive Impairment, which recognizes the value of assessment and care planning services for patients with cognitive impairment, including people living with Alzheimers disease and other forms of dementia. Medicare End-Stage Renal Disease Prospective Payment System. End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care Model (CMS-1651-P): comments to CMS/HHS regarding obstacles in many states to obtaining DME among people with Medicaid and Medicare benefits (dual eligibles).

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, grandfathering, e-prescribing, PBM disclosure requirements, specialty pharmacy, mail-service pharmacy, formulary transparency, and medical loss ratio). Regulatory and proposed legislative changes to Medicare part D including non-interference, pharmacy networks, classes of clinical concern, mail-service pharmacy, EGWP waivers, MTM expansion, long term care pharmacy, recovery audit contractors. Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs. Issues related to prescription drug abuse in Medicare. H.R.2: Medicare Access and CHIP Reauthorization Act of 2015 - provisions related to the expansion of availability of Medicare data H.R.244: The MAC Transparency Act H.R.793/S1190: The Ensuring Seniors Access to Local Pharmacies Act H.R.1021: The Protecting the Integrity of Medicare Act H.R.1600: The Patient Access to Treatments Act Provisions related to the 21st Century Cures Initiative (Energy and Commerce) and Innovations for Healthier Americans (HELP Committee). Issues related to the affordability of prescription drugs and competitive marketplace, including: pedigree, FDA user fees, manufacturer market and data exclusivity, REMS, biosimilars. H.R.804: The Access to Medicare Data Act H.R.2298: The Medicare Drug Abuse Prevention Act H.R.6: 21st Century Cures Act S.2700: The FDA and NIH Workforce Authorization Modernization Act - Provisions related to biologic drugs H.R.2841: The FAST Generics Act S.3056: The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016 H.R. 4784/S.2651: The Increasing Competition in Pharmaceuticals Act H.R. 5573/S.3094 The Price Relief, Innovation, and Competition for Essential Drugs Act or the PRICED Act

H.R.6 - Discussed the House Energy and Commerce Committee 21st Century Cures Initiative and Senate HELP Committee efforts focused on drug and medical device innovation issues. S. 31, H.R. 3061 - Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. S. 3094, H.R. 5573 - Discussed the exclusivity period for biologic drugs. Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. Discussed the need for price transparency on prescription drug prices and comparativeness effectiveness research. Discussed legislation to address the opioid abuse epidemic including fraud and abuse provisions. Discussed opioid issues generally. S. 3056 - Discussed legislation to address abuse of Risk-Evaluation and Mitigation Strategies (REMS) by brand name drug companies to block lower-cost generic drugs from entering the market. S. 1137, H.R. 9, Innovation Act, PATENT Act - Discussed patent reform legislation and related provisions on the Patent and Trademark Office inter partes review (IPR) process and proposed exemptions for brand name drug patents. S. 2956, H.R. 5054, Agriculture Appropriations, FY2017 - Lobbied in support of FDA funding. Responded to inquiry regarding Medicare Part B demonstration.

Client expense: $2,060,000 · Firm income: Not reported

H.R. 406 & S. 1767, Combination Drug Development Incentive Act of 2015; S. 632, STRONG Patents Act of 2015; H.R. 9, Innovation Act; H.R. 160, Protect Medical Innovation Act of 2015; S. 2733, Venue Equity and Non-Uniformity Elimination Act of 2016; H.R. 971 & S. 1421, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; H.R. 5573 & S. 3094, Price Relief, Innovation, and Competition for Essential Drugs (PRICED) Act; S. 3056, CREATES Act of 2016; Proposals/Initatives related to international intellectual property protection; H.R. 1806, America COMPETES Reauthorization Act of 2015;

Client expense: $1,700,000 · 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), Medicare Payment Advisory Commission (MedPAC), 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 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.

S. 314 - Pharmacy and Medically Underserved Areas Enhancement Act H.R. 592 - Pharmacy and Medically Underserved Areas Enhancement Act H.R. 1270 - Restoring Access to Medication Act of 2015 S. 709 - Restoring Access to Medication Act of 2015 S.776 - Medication Therapy Management Empowerment Act of 2015 H.R. 793 - Ensuring Seniors Access to Pharmacies Act of 2015 H.R. 1021, the Protecting the Integrity of Medicare Act (PIMA) of 2015 H.R.2 - Medicare Access and CHIP Reauthorization Act of 2015 H.R.6 - 21st Century Cures Act S.1190 - Ensuring Seniors Access to Local Pharmacies Act of 2015 S. 1913 - Stopping Medication Abuse and Protecting Seniors Act of 2015 H.R.4878 - Better Care, Lower Cost Act S. 3094 - Price Relief, Innovation, and Competition for Essential Drugs Act HR 5573 - Price Relief, Innovation and Competition for Essential Drugs Act H. R. 4641 -To provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes. HR 5210-Patient Access to Durable Medical Equipment Act S 2736-Patient Access to Durable Medical Equipment Act of 2016

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