Medicare Prescription Drug Price Negotiation Act of 2015

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: $2,610,000 · 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)

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

Policies to enhance patient access to medicines in Medicaid; Policies to enhance patient access to medicines in Medicare; H.R. 2298, Medicare Patient Safety and Drug Abuse Prevention Act; H.R. 2914, Promoting Integrity in Medicare Act; H.R. 1190 & S. 141, Protecting Seniors' Access to Medicare Act of 2015 H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act; 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. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models; Medicare payment proposals (MedPAC); Medicare Access and CHIP Reauthorization Act (MACRA);

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

General Medicare Protection, Repeal of Sustainable Growth Rate Formula, Prevention of Fraud, Waste, and Abuse: H.R. 818, Repeal of Independent Payment Advisory Board: H.R. 1190 and S. 141, Prescription Drug Re-Importation: S. 122, Negotiation of Prescription Drug Prices: S. 31 and H.R. 3061 and H.R. 3513 and S. 2023, Prevention of Catastrophic Spending on Prescription Drugs: S. 2864.

Client expense: $14,758 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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: $2,600,000 · 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: $26,000,000 · 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)

General Medicare Protection, Repeal of Sustainable Growth Rate Formula, Prevention of Fraud, Waste, and Abuse: H.R. 818, Repeal of Independent Payment Advisory Board: H.R. 1190, Negotiation of Prescription Drug Prices: H.R. 3061 and H.R. 3513. General Social Security issues, reforms to protect Social Security benefits and Social Security Trust Fund solvency (H.R. 918 and H.R. 1936), and reforms to the way Social Security COLAs are calculated (H.R. 3074 and H.R. 3500).

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

Government targets: HOUSE OF REPRESENTATIVES

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.

General Medicare Protection, Repeal of Sustainable Growth Rate Formula, Prevention of Fraud, Waste, and Abuse: H.R. 818, Repeal of Independent Payment Advisory Board: H.R. 1190 and S. 141, Prescription Drug Re-Importation: S. 122, Negotiation of Prescription Drug Prices: S. 31 and H.R. 3061 and H.R. 3513 and S. 2023, Prevention of Catastrophic Spending on Prescription Drugs: S. 2864.

Client expense: $34,846 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General Medicare Protection, Repeal of Sustainable Growth Rate Formula, Prevention of Fraud, Waste, and Abuse: H.R. 818, Repeal of Independent Payment Advisory Board: H.R. 1190, Negotiation of Prescription Drug Prices: H.R. 3061 and H.R. 3513. General Social Security issues, reforms to protect Social Security benefits and Social Security Trust Fund solvency (H.R. 918 and H.R. 1936), and reforms to the way Social Security COLAs are calculated (H.R. 3074 and H.R. 3500).

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

Government targets: HOUSE OF REPRESENTATIVES

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)

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. H.R. 3061, S. 31 - 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. Discussed the exclusivity period for biologic drugs. (no bill #) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. Discussed other prescription drug issues and potential legislation on drug importation and least costly alternative payment for Part B drugs. (no bill #) 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. (no bill #) H.R.9, S.1137 - 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. Agriculture Appropriations, FY2017 - Lobbied in support of FDA funding. (no bill #)

Client expense: $1,830,000 · Firm income: Not reported

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.

General Medicare Protection, Repeal of Sustainable Growth Rate Formula, Prevention of Fraud, Waste, and Abuse: H.R. 818, Repeal of Independent Payment Advisory Board: H.R. 1190 and S. 141, Prescription Drug Re-Importation: S. 122, Negotiation of Prescription Drug Prices: S. 31 and H.R. 3061 and H.R. 3513 and S. 2023.

Client expense: $34,846 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 6-21st Century Cures act, HR 676-Expanded and Improved Medicare for all act, S.31-Medicare Rx program, S 31/HR 3061-drug prices, Prescription drug user fees act,

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Consumer Financial Protection Bureau (CFPB), Consumer Product Safety Commission (CPSC), Environmental Protection Agency (EPA), Federal Deposit Insurance Corporation (FDIC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, White House Office

General Medicare Protection, Repeal of Sustainable Growth Rate Formula, Prevention of Fraud, Waste, and Abuse: H.R. 818, Repeal of Independent Payment Advisory Board: H.R. 1190, Negotiation of Prescription Drug Prices: H.R. 3061 and H.R. 3513. General Social Security issues, reforms to protect Social Security benefits and Social Security Trust Fund solvency (H.R. 918 and H.R. 1936), and reforms to the way Social Security COLAs are calculated (H.R. 3074 and H.R. 3500).

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

Government targets: HOUSE OF REPRESENTATIVES

H.R.4207, the Medicare Fair Drug Pricing Act H.R. 2005, the Medicare Drug Savings Act H.R.3061, the Medicare Prescription Drug Price Negotiation Act Free Care Rule Medicare Part B costs

Client expense: $234,027 · Firm income: Not reported

Government targets: Bureau of Indian Affairs (BIA), Education, Dept of, HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, White House Office

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. H.R. 3061, S. 31, 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. Discussed the exclusivity period for biologic drugs. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. Discussed other prescription drug issues and potential legislation on drug importation and least costly alternative payment for Part B drugs. (no bill) Discussed the need for data transparency on prescription drug prices and comparativeness effectiveness research. Discussed patent reform legislation (S. 1137, the PATENT Act and H.R. 9, Innovation Act) and related provisions on the Patent and Trademark Office inter partes review (IPR) process and proposed exemptions for brand name drug patents.

Client expense: $1,880,000 · Firm income: Not reported

Policies to enhance patient access to medicines in Medicaid; Policies to enhance patient access to medicines in Medicare; H.R. 2298, Medicare Patient Safety and Drug Abuse Prevention Act; H.R. 2914, Promoting Integrity in Medicare Act; H.R. 1190 & S. 141, Protecting Seniors' Access to Medicare Act of 2015; H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act; 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. 3742, Access to Marketplace Insurance Act; Medicare payment proposals;

Client expense: $1,180,000 · 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), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

HR 6-21st Century Cures act, HR 676-Expanded and Improved Medicare for all act, S.31-Medicare Rx program, S 31/HR 3061-drug prices, Prescription drug user fees act,

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Consumer Financial Protection Bureau (CFPB), Consumer Product Safety Commission (CPSC), Environmental Protection Agency (EPA), Federal Deposit Insurance Corporation (FDIC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, White House Office

General Medicare Protection, Repeal of Sustainable Growth Rate Formula, Prevention of Fraud, Waste, and Abuse: H.R. 818, Repeal of Independent Payment Advisory Board: H.R. 1190 and S. 141, Prescription Drug Re-Importation: S. 122, Negotiation of Prescription Drug Prices: S. 31 and H.R. 3061 and H.R. 3513 and S. 2023.

Client expense: $34,846 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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.

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.

General Medicare Protection, Repeal of Sustainable Growth Rate Formula, Prevention of Fraud, Waste, and Abuse: H.R. 818, Repeal of Independent Payment Advisory Board: H.R. 1190 and S. 141, Prescription Drug Re-Importation: S. 122, Negotiation of Prescription Drug Prices: S. 31 and H.R. 3061 and H.R. 3513 and S. 2023.

Client expense: $34,847 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE