ALFRED W. CORS, JR

RetireSafe worked as a leader, along with other patient advocate groups, to oppose any new cuts to the Medicare Advantage payment rates for 2016. RetireSafe worked with the Medicare Access for Patients Rx Coalition (MAPRx) to raise concerns regarding the Advance Notice of Methodological Changes for Calendar Year 2016 for Medicare Advantage Capitation Rates, Part C and Part D Payment Policies and 2016 Call Letter to express concerns related to: the Exceptions and Appeals Process, Star Ratings and the Dual-Eligibles, Formulary Oversight, Drug Utilization Review Controls, Tier Labeling and Composition, Specialty Tiers, and the Use of Multiple Tiers with Coinsurance Cost-Sharing Rates. RetireSafe joined with the Medicare Rights Center and other patient advocates to urge numerous changes to the Medicare Part D Program to make the Exceptions and Appeals Processes More Accessible for Beneficiaries. RetireSafe joined with the Healthcare Leadership Council and others to support the Protecting Seniors Access to Medicare Act, (H.R. 1190 and S. 141) to repeal the Independent Payment Advisory Board (IPAB), authorized under the Patient Protection and Affordable Care Act. Support H.R. 2624 and S. 1488, the Part D Beneficiary Appeals Fairness Act. Support the passage of H.R. 160 to repeal the 2.3% Medical Device Tax. Support the passage of H.R. 1190 to repeal the Independent Payment Advisory Board (IPAB). Joined with the MAPRx coalition to urge Congress to build on the success of Medicare Part D to ensure robust formularies, coverage for the six-protected classes, strong oversight, and transparency for consumers, as well as add improvements to the process for notice of non-coverage, appeals and exceptions. Also, urged Part D remedies to correct gaps in coverage, onerous cost-shifting created by specialty tiers, and restrictive utilization management tools that severely reduce patient benefits. Support "340B" Medicaid program reform to end widespread abuse of the drug discount program that ultimately harms patients. Joined with other patient advocate groups to comment on proposed rule: CMS-2390-P-Medicaid and Childrens Health Insurance Programs (CHIP); Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability. We supported the proposed rules intent to strengthen program integrity safeguards, and ensure beneficiary protections in areas of provider networks, coverage standards, and the treatment of appeals. We agree with the other groups that a modernized Medicaid managed care regulatory structure is essential to facilitate necessary system reform initiatives, and advance the delivery of health care for millions of people, and we supported rule changes to achieve those goals. RetireSafe joined with other patient advocates to comment on proposed rule: CMS-1631-P-Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY2016. In commenting we supported various measures for improving accuracy for primary care and care management services; providing appropriate advanced care planning services; providing better Medicare Telehealth services; providing better Chronic Care Management services for Rural Health Clinics and Qualified Health Centers; providing a useful Physicians Compare Website with data in proper context; and providing physician payment, efficiency, and quality improvements linked to a physician quality reporting system. RetireSafe joined with numerous patient groups to oppose a new CMS plan to cut the payment rate (from Average Sales Price plus 6%) for Medicare Part B Drugs administered by physicians in large parts of the U.S. because this Center for Medicare & Medicaid initiative focuses on costs rather than patients needs and health care quality. This new Part B Drug Plan will adversely impact Medicare patients with complex conditions such as cancer, macular degeneration, hypertension, rheumatoid arthritis, and primary immunodeficiency diseases. Along with many other patient advocates in the MAPRx Coalition, we strongly opposed a recent MedPAC effort to place Medicare cost savings ahead of the best interests of Medicare patients. Specifically, we urged MedPAC to reject proposals to make changes to true out-of-pocket costs (TrOOP); increase copays for low-income subsidy (LIS) beneficiaries; and eliminate any of the protected classes. RetireSafe joined with numerous patient groups to comment on the CMS Advance Notice and Draft Call Letter issued on February 19, 2016. The comments focused on better patient access to Medicare Part D Prescription Drugs and related specifically to: Specialty Tier Thresholds, Tier Labeling and Composition, Generic Tier $0 Copay Plans, Formulary Oversight, Drug Utilization Review Controls, Coverage Determination Timelines, and Access to Preferred Cost-sharing Pharmacies. RetireSafe has continued to work with a large number of patient groups (on several occasions) to strongly oppose the Centers for Medicare Services (CMS) Centers for Medicare and Medicaid Innovation (CMMI) March 8, 2016 proposed rule that would implement substantial changes to the Medicare Part B payment program. As we have stated in several joint letters to Members of Congress and to CMS, we believe the proposed changes which have been proposed as a demonstration project would impact some 75 percent of Medicare population and could limit access to the full range of available treatments under Part B to treat serious illnesses and medical treatments such as cancer, multiple sclerosis, primary immune deficiency, macular degeneration and schizophrenia. Unfortunately, the proposed program will be, in fact, mandatory for many physicians and their patients, and will cause patients to switch from the most appropriate treatment to less effective therapies or to forego treatment altogether because of transportation hurdles created by the new rule. RetireSafe also objects to the lack of sufficient stakeholder input from the beginning of this rule-making process, which has now created one-size-fits-all government payment policies that ignore patient differences and completely undermines the goal of patient-centered Medicare.

Client expense: — · Firm income: —

Matched citations: H.R. 2624

Support H.R. 3074, the CPI for Seniors Act of 2015.

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Matched citations: H.R. 3074

Support H.R. 2362, the Medical Debt Relief Act. Commented to Support new United States Food and Drug Administration (FDA) efforts to ensure patient safety through the release of draft guidance entitled Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologic License Application. Joined with the I Am (Still) Essential Coalition to urge the Secretary of Health and Human Services (HHS) to ensure that the many patient protections included in the Notice of Benefit and Payment Parameters for 2016 and the Letter to Insurers are adhered to and strictly enforced as part of the 2016 upcoming Qualified Health Plan (QHP) review. Support the passage of H.R. 6, the 21st Century Cures Act. Joined with the Health IT Now Coalition in supporting the interoperability sections of H.R. 6, the 21st Century Cures Act. RetireSafe also specifically supported provisions in H.R. 6 designed to speed up the Advisory Committee on Immunization Practices (ACIP) process through an established timeline so that much-needed new vaccines can be approved for coverage and use. Joined with numerous patient advocate organizations to urge Congress to maintain a strong and secure patent system that recognizes the rights of legitimate patent owners and addresses the new forms of abuses that have emerged in both the courts and at the U.S. Patent & Trademark Office (PTO), especially in consideration of the critical nature of strong patent protection in the development of new therapies and treatments that could benefit millions of patients suffering with substantial unmet medical needs. RetireSafe supported maintaining 12 years of data exclusivity for biologic drugs under the Trans-Pacific Partnership (TTP) trade agreement as a key U.S. priority. With National Health Council, urged CMS to include accurate drug-specific out-of-pocket (OOP) costs in the proposed OOP cost estimator under development for the federally-facilitated marketplaces for the 2016 enrollment period. RetireSafe encouraged Members of Congress to hold a formal hearing to review FDA policy and guidance regarding the safe usage of biosimilar drugs. And, with other patient groups, advocated Risk Evaluation and Mitigation Strategies (REMS) and other rigorous safeguards to ensure the safe use of biosimilar drugs, especially for any federally mandated use. RetireSafe joined with 124 patient and community organizations to provide extensive comments on the Notice of Benefit and Payment Parameters for 2017 Proposed Rule, CMS 9937-P. Those comments included support for the proposed Standard Benefit Option (SBO) that will better enable consumers to compare plans and make informed choices. While we generally supported the SBO design, we expressed concern over the use of the Specialty Drug Tier and its use as a broad catch-all class insurers use to increase patient costs. We urged HHS to make all medications not subject to a deductible in all metal levels and tier levels, as we strongly believe that prescription medications should not be subject to a plans deductible. We also support the proposal that patient cost-sharing for most tiers and metal levels utilize reasonable cost-sharing, and oppose the use of coinsurance for the Specialty Drug Tier. We also repeated previous recommendations, and made some new ones that would better protect enrollees access to needed prescription drugs, in addition to recommendations that would better ensure critical continuity of care. In addition, RetireSafe joined with 197 patient and community organizations to comment on the Office for Civil Rights, ACA Non-discrimination Proposed Rule (RIN 0945-AA02). We were especially interested in one key ACA provision, Section 1557, which prohibits discrimination in the health care system on the basis of race, color, national origin, sex, age or disability. While we were pleased to see the long awaited proposed regulation to implement Sec. 1557 finally issued, we did not think the proposal went far enough in defining discriminatory practices in plan benefit design as it relates to all beneficiaries, particularly those with serious and chronic health conditions who rely on prescription medications and other health care services. We urged HHS to better define what discriminatory plan practices are in the final rule. RetireSafe also joined with a number of patient groups to again highlight in comments to HHS the importance of Nondiscrimination in Health-Related Insurance; the importance of the Designation of Responsible Employees and the Adoption of Grievance Procedures; and finally, that Notice Requirements require that covered entities consider the needs of all beneficiaries, so that they may be fully aware of their rights under the law. RetireSafe joined with 124 patient organizations in the I Am Essential coalition to voice strong support for the Obama Administrations proposed patient protections that health insurance companies must include as they develop their 2017 Qualified Health Plans (QHPs), and continued to call on the Administration to actually enforce those critical patient protections. While we are encouraged by repeated statements that plans cannot discriminate against patients by, for example, placing every drug to treat a certain condition on the highest cost-sharing tier, we have seen little evidence of actual enforcement. We supported the U.S. Senate version of the Medical Debt Relief Act (S. 2592). RetireSafe continues to join with other patient groups to urge the Food and Drug Administration (FDA) to require distinct, unique naming for any and all biosimilar drugs approved for use in the United States. We support the FDAs leadership in creating a system of distinguishable names for all biologic medicines, including biosimilars. This system recognizes the fact that biosimilars are not exact copies of their reference products, enhances patient safety and promotes pharmacovigilance. RetireSafe joined roughly 40 other patient groups to provide specific input to the Institute for Clinical and Economic Review (ICER) urging a patient-centric approach to ICERs ongoing assessment of value-based treatments. ICERs determinations impact the private (and to some degree public) health insurance landscape relative to which treatments are approved for use and reimbursement. RetireSafe believes the individual patient perspective must be the critical element of the ICER assessment process going forward. RetireSafe joined with 153 patient advocacy groups in the I Am Essential coalition to respond by letter to Health and Human Services (HHS) Secretary Sylvia Mathews Burwell regarding the HHS Notice of Benefit and Payment Parameters (NBPP) for the 2018 Proposed Rule. The letter praised HHS proposals that create additional standardized plan options and utilize copays rather than co-insurance. The letter also emphasized the continued need for greater patient protections that end discriminatory practices that put patients at risk. The groups reiterated their longstanding opposition to the use of co-insurance on specialty drug tiers, which unfairly targets those with chronic and serious conditions and makes it difficult for beneficiaries to calculate costs before enrolling. The letter also highlighted other barriers to care, including excess utilization management and the lack of formulary coverage for prescribed medications.

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Matched citations: H.R. 6

Joined with more than one hundred patient advocate organizations to urge Congress to amend H.R. 9 (the Innovation Act) to preserve important patent protections for the biopharmaceutical innovation needed to encourage cures and to develop therapies that will allow our respective patient communities to achieve a better quality of life. We urged the strongest patent protections to sustain and incentivize medical research.

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Matched citations: H.R. 9

RetireSafe worked as a leader, along with other patient advocate groups, to oppose any new cuts to the Medicare Advantage payment rates for 2016. RetireSafe worked with the Medicare Access for Patients Rx Coalition (MAPRx) to raise concerns regarding the Advance Notice of Methodological Changes for Calendar Year 2016 for Medicare Advantage Capitation Rates, Part C and Part D Payment Policies and 2016 Call Letter to express concerns related to: the Exceptions and Appeals Process, Star Ratings and the Dual-Eligibles, Formulary Oversight, Drug Utilization Review Controls, Tier Labeling and Composition, Specialty Tiers, and the Use of Multiple Tiers with Coinsurance Cost-Sharing Rates. RetireSafe joined with the Medicare Rights Center and other patient advocates to urge numerous changes to the Medicare Part D Program to make the Exceptions and Appeals Processes More Accessible for Beneficiaries. RetireSafe joined with the Healthcare Leadership Council and others to support the Protecting Seniors Access to Medicare Act, (H.R. 1190 and S. 141) to repeal the Independent Payment Advisory Board (IPAB), authorized under the Patient Protection and Affordable Care Act. Support H.R. 2624 and S. 1488, the Part D Beneficiary Appeals Fairness Act. Support the passage of H.R. 160 to repeal the 2.3% Medical Device Tax. Support the passage of H.R. 1190 to repeal the Independent Payment Advisory Board (IPAB). Joined with the MAPRx coalition to urge Congress to build on the success of Medicare Part D to ensure robust formularies, coverage for the six-protected classes, strong oversight, and transparency for consumers, as well as add improvements to the process for notice of non-coverage, appeals and exceptions. Also, urged Part D remedies to correct gaps in coverage, onerous cost-shifting created by specialty tiers, and restrictive utilization management tools that severely reduce patient benefits. Support "340B" Medicaid program reform to end widespread abuse of the drug discount program that ultimately harms patients. Joined with other patient advocate groups to comment on proposed rule: CMS-2390-P-Medicaid and Childrens Health Insurance Programs (CHIP); Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability. We supported the proposed rules intent to strengthen program integrity safeguards, and ensure beneficiary protections in areas of provider networks, coverage standards, and the treatment of appeals. We agree with the other groups that a modernized Medicaid managed care regulatory structure is essential to facilitate necessary system reform initiatives, and advance the delivery of health care for millions of people, and we supported rule changes to achieve those goals. RetireSafe joined with other patient advocates to comment on proposed rule: CMS-1631-P-Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY2016. In commenting we supported various measures for improving accuracy for primary care and care management services; providing appropriate advanced care planning services; providing better Medicare Telehealth services; providing better Chronic Care Management services for Rural Health Clinics and Qualified Health Centers; providing a useful Physicians Compare Website with data in proper context; and providing physician payment, efficiency, and quality improvements linked to a physician quality reporting system. RetireSafe joined with numerous patient groups to oppose a new CMS plan to cut the payment rate (from Average Sales Price plus 6%) for Medicare Part B Drugs administered by physicians in large parts of the U.S. because this Center for Medicare & Medicaid initiative focuses on costs rather than patients needs and health care quality. This new Part B Drug Plan will adversely impact Medicare patients with complex conditions such as cancer, macular degeneration, hypertension, rheumatoid arthritis, and primary immunodeficiency diseases. Along with many other patient advocates in the MAPRx Coalition, we strongly opposed a recent MedPAC effort to place Medicare cost savings ahead of the best interests of Medicare patients. Specifically, we urged MedPAC to reject proposals to make changes to true out-of-pocket costs (TrOOP); increase copays for low-income subsidy (LIS) beneficiaries; and eliminate any of the protected classes. RetireSafe joined with numerous patient groups to comment on the CMS Advance Notice and Draft Call Letter issued on February 19, 2016. The comments focused on better patient access to Medicare Part D Prescription Drugs and related specifically to: Specialty Tier Thresholds, Tier Labeling and Composition, Generic Tier $0 Copay Plans, Formulary Oversight, Drug Utilization Review Controls, Coverage Determination Timelines, and Access to Preferred Cost-sharing Pharmacies. RetireSafe has continued to work with a large number of patient groups (on several occasions) to strongly oppose the Centers for Medicare Services (CMS) Centers for Medicare and Medicaid Innovation (CMMI) March 8, 2016 proposed rule that would implement substantial changes to the Medicare Part B payment program. As we have stated in several joint letters to Members of Congress and to CMS, we believe the proposed changes which have been proposed as a demonstration project would impact some 75 percent of Medicare population and could limit access to the full range of available treatments under Part B to treat serious illnesses and medical treatments such as cancer, multiple sclerosis, primary immune deficiency, macular degeneration and schizophrenia. Unfortunately, the proposed program will be, in fact, mandatory for many physicians and their patients, and will cause patients to switch from the most appropriate treatment to less effective therapies or to forego treatment altogether because of transportation hurdles created by the new rule. RetireSafe also objects to the lack of sufficient stakeholder input from the beginning of this rule-making process, which has now created one-size-fits-all government payment policies that ignore patient differences and completely undermines the goal of patient-centered Medicare.

Client expense: — · Firm income: —

Matched citations: S. 141

RetireSafe worked as a leader, along with other patient advocate groups, to oppose any new cuts to the Medicare Advantage payment rates for 2016. RetireSafe worked with the Medicare Access for Patients Rx Coalition (MAPRx) to raise concerns regarding the Advance Notice of Methodological Changes for Calendar Year 2016 for Medicare Advantage Capitation Rates, Part C and Part D Payment Policies and 2016 Call Letter to express concerns related to: the Exceptions and Appeals Process, Star Ratings and the Dual-Eligibles, Formulary Oversight, Drug Utilization Review Controls, Tier Labeling and Composition, Specialty Tiers, and the Use of Multiple Tiers with Coinsurance Cost-Sharing Rates. RetireSafe joined with the Medicare Rights Center and other patient advocates to urge numerous changes to the Medicare Part D Program to make the Exceptions and Appeals Processes More Accessible for Beneficiaries. RetireSafe joined with the Healthcare Leadership Council and others to support the Protecting Seniors Access to Medicare Act, (H.R. 1190 and S. 141) to repeal the Independent Payment Advisory Board (IPAB), authorized under the Patient Protection and Affordable Care Act. Support H.R. 2624 and S. 1488, the Part D Beneficiary Appeals Fairness Act. Support the passage of H.R. 160 to repeal the 2.3% Medical Device Tax. Support the passage of H.R. 1190 to repeal the Independent Payment Advisory Board (IPAB). Joined with the MAPRx coalition to urge Congress to build on the success of Medicare Part D to ensure robust formularies, coverage for the six-protected classes, strong oversight, and transparency for consumers, as well as add improvements to the process for notice of non-coverage, appeals and exceptions. Also, urged Part D remedies to correct gaps in coverage, onerous cost-shifting created by specialty tiers, and restrictive utilization management tools that severely reduce patient benefits. Support "340B" Medicaid program reform to end widespread abuse of the drug discount program that ultimately harms patients. Joined with other patient advocate groups to comment on proposed rule: CMS-2390-P-Medicaid and Childrens Health Insurance Programs (CHIP); Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability. We supported the proposed rules intent to strengthen program integrity safeguards, and ensure beneficiary protections in areas of provider networks, coverage standards, and the treatment of appeals. We agree with the other groups that a modernized Medicaid managed care regulatory structure is essential to facilitate necessary system reform initiatives, and advance the delivery of health care for millions of people, and we supported rule changes to achieve those goals. RetireSafe joined with other patient advocates to comment on proposed rule: CMS-1631-P-Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY2016. In commenting we supported various measures for improving accuracy for primary care and care management services; providing appropriate advanced care planning services; providing better Medicare Telehealth services; providing better Chronic Care Management services for Rural Health Clinics and Qualified Health Centers; providing a useful Physicians Compare Website with data in proper context; and providing physician payment, efficiency, and quality improvements linked to a physician quality reporting system. RetireSafe joined with numerous patient groups to oppose a new CMS plan to cut the payment rate (from Average Sales Price plus 6%) for Medicare Part B Drugs administered by physicians in large parts of the U.S. because this Center for Medicare & Medicaid initiative focuses on costs rather than patients needs and health care quality. This new Part B Drug Plan will adversely impact Medicare patients with complex conditions such as cancer, macular degeneration, hypertension, rheumatoid arthritis, and primary immunodeficiency diseases. Along with many other patient advocates in the MAPRx Coalition, we strongly opposed a recent MedPAC effort to place Medicare cost savings ahead of the best interests of Medicare patients. Specifically, we urged MedPAC to reject proposals to make changes to true out-of-pocket costs (TrOOP); increase copays for low-income subsidy (LIS) beneficiaries; and eliminate any of the protected classes. RetireSafe joined with numerous patient groups to comment on the CMS Advance Notice and Draft Call Letter issued on February 19, 2016. The comments focused on better patient access to Medicare Part D Prescription Drugs and related specifically to: Specialty Tier Thresholds, Tier Labeling and Composition, Generic Tier $0 Copay Plans, Formulary Oversight, Drug Utilization Review Controls, Coverage Determination Timelines, and Access to Preferred Cost-sharing Pharmacies. RetireSafe has continued to work with a large number of patient groups (on several occasions) to strongly oppose the Centers for Medicare Services (CMS) Centers for Medicare and Medicaid Innovation (CMMI) March 8, 2016 proposed rule that would implement substantial changes to the Medicare Part B payment program. As we have stated in several joint letters to Members of Congress and to CMS, we believe the proposed changes which have been proposed as a demonstration project would impact some 75 percent of Medicare population and could limit access to the full range of available treatments under Part B to treat serious illnesses and medical treatments such as cancer, multiple sclerosis, primary immune deficiency, macular degeneration and schizophrenia. Unfortunately, the proposed program will be, in fact, mandatory for many physicians and their patients, and will cause patients to switch from the most appropriate treatment to less effective therapies or to forego treatment altogether because of transportation hurdles created by the new rule. RetireSafe also objects to the lack of sufficient stakeholder input from the beginning of this rule-making process, which has now created one-size-fits-all government payment policies that ignore patient differences and completely undermines the goal of patient-centered Medicare.

Client expense: — · Firm income: —

Matched citations: S. 1488

Support H.R. 2362, the Medical Debt Relief Act. Commented to Support new United States Food and Drug Administration (FDA) efforts to ensure patient safety through the release of draft guidance entitled Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologic License Application. Joined with the I Am (Still) Essential Coalition to urge the Secretary of Health and Human Services (HHS) to ensure that the many patient protections included in the Notice of Benefit and Payment Parameters for 2016 and the Letter to Insurers are adhered to and strictly enforced as part of the 2016 upcoming Qualified Health Plan (QHP) review. Support the passage of H.R. 6, the 21st Century Cures Act. Joined with the Health IT Now Coalition in supporting the interoperability sections of H.R. 6, the 21st Century Cures Act. RetireSafe also specifically supported provisions in H.R. 6 designed to speed up the Advisory Committee on Immunization Practices (ACIP) process through an established timeline so that much-needed new vaccines can be approved for coverage and use. Joined with numerous patient advocate organizations to urge Congress to maintain a strong and secure patent system that recognizes the rights of legitimate patent owners and addresses the new forms of abuses that have emerged in both the courts and at the U.S. Patent & Trademark Office (PTO), especially in consideration of the critical nature of strong patent protection in the development of new therapies and treatments that could benefit millions of patients suffering with substantial unmet medical needs. RetireSafe supported maintaining 12 years of data exclusivity for biologic drugs under the Trans-Pacific Partnership (TTP) trade agreement as a key U.S. priority. With National Health Council, urged CMS to include accurate drug-specific out-of-pocket (OOP) costs in the proposed OOP cost estimator under development for the federally-facilitated marketplaces for the 2016 enrollment period. RetireSafe encouraged Members of Congress to hold a formal hearing to review FDA policy and guidance regarding the safe usage of biosimilar drugs. And, with other patient groups, advocated Risk Evaluation and Mitigation Strategies (REMS) and other rigorous safeguards to ensure the safe use of biosimilar drugs, especially for any federally mandated use. RetireSafe joined with 124 patient and community organizations to provide extensive comments on the Notice of Benefit and Payment Parameters for 2017 Proposed Rule, CMS 9937-P. Those comments included support for the proposed Standard Benefit Option (SBO) that will better enable consumers to compare plans and make informed choices. While we generally supported the SBO design, we expressed concern over the use of the Specialty Drug Tier and its use as a broad catch-all class insurers use to increase patient costs. We urged HHS to make all medications not subject to a deductible in all metal levels and tier levels, as we strongly believe that prescription medications should not be subject to a plans deductible. We also support the proposal that patient cost-sharing for most tiers and metal levels utilize reasonable cost-sharing, and oppose the use of coinsurance for the Specialty Drug Tier. We also repeated previous recommendations, and made some new ones that would better protect enrollees access to needed prescription drugs, in addition to recommendations that would better ensure critical continuity of care. In addition, RetireSafe joined with 197 patient and community organizations to comment on the Office for Civil Rights, ACA Non-discrimination Proposed Rule (RIN 0945-AA02). We were especially interested in one key ACA provision, Section 1557, which prohibits discrimination in the health care system on the basis of race, color, national origin, sex, age or disability. While we were pleased to see the long awaited proposed regulation to implement Sec. 1557 finally issued, we did not think the proposal went far enough in defining discriminatory practices in plan benefit design as it relates to all beneficiaries, particularly those with serious and chronic health conditions who rely on prescription medications and other health care services. We urged HHS to better define what discriminatory plan practices are in the final rule. RetireSafe also joined with a number of patient groups to again highlight in comments to HHS the importance of Nondiscrimination in Health-Related Insurance; the importance of the Designation of Responsible Employees and the Adoption of Grievance Procedures; and finally, that Notice Requirements require that covered entities consider the needs of all beneficiaries, so that they may be fully aware of their rights under the law. RetireSafe joined with 124 patient organizations in the I Am Essential coalition to voice strong support for the Obama Administrations proposed patient protections that health insurance companies must include as they develop their 2017 Qualified Health Plans (QHPs), and continued to call on the Administration to actually enforce those critical patient protections. While we are encouraged by repeated statements that plans cannot discriminate against patients by, for example, placing every drug to treat a certain condition on the highest cost-sharing tier, we have seen little evidence of actual enforcement. We supported the U.S. Senate version of the Medical Debt Relief Act (S. 2592). RetireSafe continues to join with other patient groups to urge the Food and Drug Administration (FDA) to require distinct, unique naming for any and all biosimilar drugs approved for use in the United States. We support the FDAs leadership in creating a system of distinguishable names for all biologic medicines, including biosimilars. This system recognizes the fact that biosimilars are not exact copies of their reference products, enhances patient safety and promotes pharmacovigilance. RetireSafe joined roughly 40 other patient groups to provide specific input to the Institute for Clinical and Economic Review (ICER) urging a patient-centric approach to ICERs ongoing assessment of value-based treatments. ICERs determinations impact the private (and to some degree public) health insurance landscape relative to which treatments are approved for use and reimbursement. RetireSafe believes the individual patient perspective must be the critical element of the ICER assessment process going forward. RetireSafe joined with 153 patient advocacy groups in the I Am Essential coalition to respond by letter to Health and Human Services (HHS) Secretary Sylvia Mathews Burwell regarding the HHS Notice of Benefit and Payment Parameters (NBPP) for the 2018 Proposed Rule. The letter praised HHS proposals that create additional standardized plan options and utilize copays rather than co-insurance. The letter also emphasized the continued need for greater patient protections that end discriminatory practices that put patients at risk. The groups reiterated their longstanding opposition to the use of co-insurance on specialty drug tiers, which unfairly targets those with chronic and serious conditions and makes it difficult for beneficiaries to calculate costs before enrolling. The letter also highlighted other barriers to care, including excess utilization management and the lack of formulary coverage for prescribed medications.

Client expense: — · Firm income: —

Matched citations: S. 2592

RetireSafe supports the Promoting Automotive Repair, Trade, and Sales (PARTS) Act (S. 560 and H.R. 1057).

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Matched citations: S. 560

RetireSafe supports the Promoting Automotive Repair, Trade, and Sales (PARTS) Act (S. 560 and H.R. 1057).

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Matched citations: H.R. 1057

RetireSafe worked as a leader, along with other patient advocate groups, to oppose any new cuts to the Medicare Advantage payment rates for 2016. RetireSafe worked with the Medicare Access for Patients Rx Coalition (MAPRx) to raise concerns regarding the Advance Notice of Methodological Changes for Calendar Year 2016 for Medicare Advantage Capitation Rates, Part C and Part D Payment Policies and 2016 Call Letter to express concerns related to: the Exceptions and Appeals Process, Star Ratings and the Dual-Eligibles, Formulary Oversight, Drug Utilization Review Controls, Tier Labeling and Composition, Specialty Tiers, and the Use of Multiple Tiers with Coinsurance Cost-Sharing Rates. RetireSafe joined with the Medicare Rights Center and other patient advocates to urge numerous changes to the Medicare Part D Program to make the Exceptions and Appeals Processes More Accessible for Beneficiaries. RetireSafe joined with the Healthcare Leadership Council and others to support the Protecting Seniors Access to Medicare Act, (H.R. 1190 and S. 141) to repeal the Independent Payment Advisory Board (IPAB), authorized under the Patient Protection and Affordable Care Act. Support H.R. 2624 and S. 1488, the Part D Beneficiary Appeals Fairness Act. Support the passage of H.R. 160 to repeal the 2.3% Medical Device Tax. Support the passage of H.R. 1190 to repeal the Independent Payment Advisory Board (IPAB). Joined with the MAPRx coalition to urge Congress to build on the success of Medicare Part D to ensure robust formularies, coverage for the six-protected classes, strong oversight, and transparency for consumers, as well as add improvements to the process for notice of non-coverage, appeals and exceptions. Also, urged Part D remedies to correct gaps in coverage, onerous cost-shifting created by specialty tiers, and restrictive utilization management tools that severely reduce patient benefits. Support "340B" Medicaid program reform to end widespread abuse of the drug discount program that ultimately harms patients. Joined with other patient advocate groups to comment on proposed rule: CMS-2390-P-Medicaid and Childrens Health Insurance Programs (CHIP); Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability. We supported the proposed rules intent to strengthen program integrity safeguards, and ensure beneficiary protections in areas of provider networks, coverage standards, and the treatment of appeals. We agree with the other groups that a modernized Medicaid managed care regulatory structure is essential to facilitate necessary system reform initiatives, and advance the delivery of health care for millions of people, and we supported rule changes to achieve those goals. RetireSafe joined with other patient advocates to comment on proposed rule: CMS-1631-P-Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY2016. In commenting we supported various measures for improving accuracy for primary care and care management services; providing appropriate advanced care planning services; providing better Medicare Telehealth services; providing better Chronic Care Management services for Rural Health Clinics and Qualified Health Centers; providing a useful Physicians Compare Website with data in proper context; and providing physician payment, efficiency, and quality improvements linked to a physician quality reporting system. RetireSafe joined with numerous patient groups to oppose a new CMS plan to cut the payment rate (from Average Sales Price plus 6%) for Medicare Part B Drugs administered by physicians in large parts of the U.S. because this Center for Medicare & Medicaid initiative focuses on costs rather than patients needs and health care quality. This new Part B Drug Plan will adversely impact Medicare patients with complex conditions such as cancer, macular degeneration, hypertension, rheumatoid arthritis, and primary immunodeficiency diseases. Along with many other patient advocates in the MAPRx Coalition, we strongly opposed a recent MedPAC effort to place Medicare cost savings ahead of the best interests of Medicare patients. Specifically, we urged MedPAC to reject proposals to make changes to true out-of-pocket costs (TrOOP); increase copays for low-income subsidy (LIS) beneficiaries; and eliminate any of the protected classes. RetireSafe joined with numerous patient groups to comment on the CMS Advance Notice and Draft Call Letter issued on February 19, 2016. The comments focused on better patient access to Medicare Part D Prescription Drugs and related specifically to: Specialty Tier Thresholds, Tier Labeling and Composition, Generic Tier $0 Copay Plans, Formulary Oversight, Drug Utilization Review Controls, Coverage Determination Timelines, and Access to Preferred Cost-sharing Pharmacies. RetireSafe has continued to work with a large number of patient groups (on several occasions) to strongly oppose the Centers for Medicare Services (CMS) Centers for Medicare and Medicaid Innovation (CMMI) March 8, 2016 proposed rule that would implement substantial changes to the Medicare Part B payment program. As we have stated in several joint letters to Members of Congress and to CMS, we believe the proposed changes which have been proposed as a demonstration project would impact some 75 percent of Medicare population and could limit access to the full range of available treatments under Part B to treat serious illnesses and medical treatments such as cancer, multiple sclerosis, primary immune deficiency, macular degeneration and schizophrenia. Unfortunately, the proposed program will be, in fact, mandatory for many physicians and their patients, and will cause patients to switch from the most appropriate treatment to less effective therapies or to forego treatment altogether because of transportation hurdles created by the new rule. RetireSafe also objects to the lack of sufficient stakeholder input from the beginning of this rule-making process, which has now created one-size-fits-all government payment policies that ignore patient differences and completely undermines the goal of patient-centered Medicare.

Client expense: — · Firm income: —

Matched citations: H.R. 1190

RetireSafe worked as a leader, along with other patient advocate groups, to oppose any new cuts to the Medicare Advantage payment rates for 2016. RetireSafe worked with the Medicare Access for Patients Rx Coalition (MAPRx) to raise concerns regarding the Advance Notice of Methodological Changes for Calendar Year 2016 for Medicare Advantage Capitation Rates, Part C and Part D Payment Policies and 2016 Call Letter to express concerns related to: the Exceptions and Appeals Process, Star Ratings and the Dual-Eligibles, Formulary Oversight, Drug Utilization Review Controls, Tier Labeling and Composition, Specialty Tiers, and the Use of Multiple Tiers with Coinsurance Cost-Sharing Rates. RetireSafe joined with the Medicare Rights Center and other patient advocates to urge numerous changes to the Medicare Part D Program to make the Exceptions and Appeals Processes More Accessible for Beneficiaries. RetireSafe joined with the Healthcare Leadership Council and others to support the Protecting Seniors Access to Medicare Act, (H.R. 1190 and S. 141) to repeal the Independent Payment Advisory Board (IPAB), authorized under the Patient Protection and Affordable Care Act. Support H.R. 2624 and S. 1488, the Part D Beneficiary Appeals Fairness Act. Support the passage of H.R. 160 to repeal the 2.3% Medical Device Tax. Support the passage of H.R. 1190 to repeal the Independent Payment Advisory Board (IPAB). Joined with the MAPRx coalition to urge Congress to build on the success of Medicare Part D to ensure robust formularies, coverage for the six-protected classes, strong oversight, and transparency for consumers, as well as add improvements to the process for notice of non-coverage, appeals and exceptions. Also, urged Part D remedies to correct gaps in coverage, onerous cost-shifting created by specialty tiers, and restrictive utilization management tools that severely reduce patient benefits. Support "340B" Medicaid program reform to end widespread abuse of the drug discount program that ultimately harms patients. Joined with other patient advocate groups to comment on proposed rule: CMS-2390-P-Medicaid and Childrens Health Insurance Programs (CHIP); Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability. We supported the proposed rules intent to strengthen program integrity safeguards, and ensure beneficiary protections in areas of provider networks, coverage standards, and the treatment of appeals. We agree with the other groups that a modernized Medicaid managed care regulatory structure is essential to facilitate necessary system reform initiatives, and advance the delivery of health care for millions of people, and we supported rule changes to achieve those goals. RetireSafe joined with other patient advocates to comment on proposed rule: CMS-1631-P-Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY2016. In commenting we supported various measures for improving accuracy for primary care and care management services; providing appropriate advanced care planning services; providing better Medicare Telehealth services; providing better Chronic Care Management services for Rural Health Clinics and Qualified Health Centers; providing a useful Physicians Compare Website with data in proper context; and providing physician payment, efficiency, and quality improvements linked to a physician quality reporting system. RetireSafe joined with numerous patient groups to oppose a new CMS plan to cut the payment rate (from Average Sales Price plus 6%) for Medicare Part B Drugs administered by physicians in large parts of the U.S. because this Center for Medicare & Medicaid initiative focuses on costs rather than patients needs and health care quality. This new Part B Drug Plan will adversely impact Medicare patients with complex conditions such as cancer, macular degeneration, hypertension, rheumatoid arthritis, and primary immunodeficiency diseases. Along with many other patient advocates in the MAPRx Coalition, we strongly opposed a recent MedPAC effort to place Medicare cost savings ahead of the best interests of Medicare patients. Specifically, we urged MedPAC to reject proposals to make changes to true out-of-pocket costs (TrOOP); increase copays for low-income subsidy (LIS) beneficiaries; and eliminate any of the protected classes. RetireSafe joined with numerous patient groups to comment on the CMS Advance Notice and Draft Call Letter issued on February 19, 2016. The comments focused on better patient access to Medicare Part D Prescription Drugs and related specifically to: Specialty Tier Thresholds, Tier Labeling and Composition, Generic Tier $0 Copay Plans, Formulary Oversight, Drug Utilization Review Controls, Coverage Determination Timelines, and Access to Preferred Cost-sharing Pharmacies. RetireSafe has continued to work with a large number of patient groups (on several occasions) to strongly oppose the Centers for Medicare Services (CMS) Centers for Medicare and Medicaid Innovation (CMMI) March 8, 2016 proposed rule that would implement substantial changes to the Medicare Part B payment program. As we have stated in several joint letters to Members of Congress and to CMS, we believe the proposed changes which have been proposed as a demonstration project would impact some 75 percent of Medicare population and could limit access to the full range of available treatments under Part B to treat serious illnesses and medical treatments such as cancer, multiple sclerosis, primary immune deficiency, macular degeneration and schizophrenia. Unfortunately, the proposed program will be, in fact, mandatory for many physicians and their patients, and will cause patients to switch from the most appropriate treatment to less effective therapies or to forego treatment altogether because of transportation hurdles created by the new rule. RetireSafe also objects to the lack of sufficient stakeholder input from the beginning of this rule-making process, which has now created one-size-fits-all government payment policies that ignore patient differences and completely undermines the goal of patient-centered Medicare.

Client expense: — · Firm income: —

Matched citations: H.R. 160

Support H.R. 2362, the Medical Debt Relief Act. Commented to Support new United States Food and Drug Administration (FDA) efforts to ensure patient safety through the release of draft guidance entitled Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologic License Application. Joined with the I Am (Still) Essential Coalition to urge the Secretary of Health and Human Services (HHS) to ensure that the many patient protections included in the Notice of Benefit and Payment Parameters for 2016 and the Letter to Insurers are adhered to and strictly enforced as part of the 2016 upcoming Qualified Health Plan (QHP) review. Support the passage of H.R. 6, the 21st Century Cures Act. Joined with the Health IT Now Coalition in supporting the interoperability sections of H.R. 6, the 21st Century Cures Act. RetireSafe also specifically supported provisions in H.R. 6 designed to speed up the Advisory Committee on Immunization Practices (ACIP) process through an established timeline so that much-needed new vaccines can be approved for coverage and use. Joined with numerous patient advocate organizations to urge Congress to maintain a strong and secure patent system that recognizes the rights of legitimate patent owners and addresses the new forms of abuses that have emerged in both the courts and at the U.S. Patent & Trademark Office (PTO), especially in consideration of the critical nature of strong patent protection in the development of new therapies and treatments that could benefit millions of patients suffering with substantial unmet medical needs. RetireSafe supported maintaining 12 years of data exclusivity for biologic drugs under the Trans-Pacific Partnership (TTP) trade agreement as a key U.S. priority. With National Health Council, urged CMS to include accurate drug-specific out-of-pocket (OOP) costs in the proposed OOP cost estimator under development for the federally-facilitated marketplaces for the 2016 enrollment period. RetireSafe encouraged Members of Congress to hold a formal hearing to review FDA policy and guidance regarding the safe usage of biosimilar drugs. And, with other patient groups, advocated Risk Evaluation and Mitigation Strategies (REMS) and other rigorous safeguards to ensure the safe use of biosimilar drugs, especially for any federally mandated use. RetireSafe joined with 124 patient and community organizations to provide extensive comments on the Notice of Benefit and Payment Parameters for 2017 Proposed Rule, CMS 9937-P. Those comments included support for the proposed Standard Benefit Option (SBO) that will better enable consumers to compare plans and make informed choices. While we generally supported the SBO design, we expressed concern over the use of the Specialty Drug Tier and its use as a broad catch-all class insurers use to increase patient costs. We urged HHS to make all medications not subject to a deductible in all metal levels and tier levels, as we strongly believe that prescription medications should not be subject to a plans deductible. We also support the proposal that patient cost-sharing for most tiers and metal levels utilize reasonable cost-sharing, and oppose the use of coinsurance for the Specialty Drug Tier. We also repeated previous recommendations, and made some new ones that would better protect enrollees access to needed prescription drugs, in addition to recommendations that would better ensure critical continuity of care. In addition, RetireSafe joined with 197 patient and community organizations to comment on the Office for Civil Rights, ACA Non-discrimination Proposed Rule (RIN 0945-AA02). We were especially interested in one key ACA provision, Section 1557, which prohibits discrimination in the health care system on the basis of race, color, national origin, sex, age or disability. While we were pleased to see the long awaited proposed regulation to implement Sec. 1557 finally issued, we did not think the proposal went far enough in defining discriminatory practices in plan benefit design as it relates to all beneficiaries, particularly those with serious and chronic health conditions who rely on prescription medications and other health care services. We urged HHS to better define what discriminatory plan practices are in the final rule. RetireSafe also joined with a number of patient groups to again highlight in comments to HHS the importance of Nondiscrimination in Health-Related Insurance; the importance of the Designation of Responsible Employees and the Adoption of Grievance Procedures; and finally, that Notice Requirements require that covered entities consider the needs of all beneficiaries, so that they may be fully aware of their rights under the law. RetireSafe joined with 124 patient organizations in the I Am Essential coalition to voice strong support for the Obama Administrations proposed patient protections that health insurance companies must include as they develop their 2017 Qualified Health Plans (QHPs), and continued to call on the Administration to actually enforce those critical patient protections. While we are encouraged by repeated statements that plans cannot discriminate against patients by, for example, placing every drug to treat a certain condition on the highest cost-sharing tier, we have seen little evidence of actual enforcement. We supported the U.S. Senate version of the Medical Debt Relief Act (S. 2592). RetireSafe continues to join with other patient groups to urge the Food and Drug Administration (FDA) to require distinct, unique naming for any and all biosimilar drugs approved for use in the United States. We support the FDAs leadership in creating a system of distinguishable names for all biologic medicines, including biosimilars. This system recognizes the fact that biosimilars are not exact copies of their reference products, enhances patient safety and promotes pharmacovigilance. RetireSafe joined roughly 40 other patient groups to provide specific input to the Institute for Clinical and Economic Review (ICER) urging a patient-centric approach to ICERs ongoing assessment of value-based treatments. ICERs determinations impact the private (and to some degree public) health insurance landscape relative to which treatments are approved for use and reimbursement. RetireSafe believes the individual patient perspective must be the critical element of the ICER assessment process going forward.

Client expense: — · Firm income: —

Matched citations: H.R. 2362

RetireSafe worked as a leader, along with other patient advocate groups, to oppose any new cuts to the Medicare Advantage payment rates for 2016. RetireSafe worked with the Medicare Access for Patients Rx Coalition (MAPRx) to raise concerns regarding the Advance Notice of Methodological Changes for Calendar Year 2016 for Medicare Advantage Capitation Rates, Part C and Part D Payment Policies and 2016 Call Letter to express concerns related to: the Exceptions and Appeals Process, Star Ratings and the Dual-Eligibles, Formulary Oversight, Drug Utilization Review Controls, Tier Labeling and Composition, Specialty Tiers, and the Use of Multiple Tiers with Coinsurance Cost-Sharing Rates. RetireSafe joined with the Medicare Rights Center and other patient advocates to urge numerous changes to the Medicare Part D Program to make the Exceptions and Appeals Processes More Accessible for Beneficiaries. RetireSafe joined with the Healthcare Leadership Council and others to support the Protecting Seniors Access to Medicare Act, (H.R. 1190 and S. 141) to repeal the Independent Payment Advisory Board (IPAB), authorized under the Patient Protection and Affordable Care Act. Support H.R. 2624 and S. 1488, the Part D Beneficiary Appeals Fairness Act. Support the passage of H.R. 160 to repeal the 2.3% Medical Device Tax. Support the passage of H.R. 1190 to repeal the Independent Payment Advisory Board (IPAB). Joined with the MAPRx coalition to urge Congress to build on the success of Medicare Part D to ensure robust formularies, coverage for the six-protected classes, strong oversight, and transparency for consumers, as well as add improvements to the process for notice of non-coverage, appeals and exceptions. Also, urged Part D remedies to correct gaps in coverage, onerous cost-shifting created by specialty tiers, and restrictive utilization management tools that severely reduce patient benefits. Support "340B" Medicaid program reform to end widespread abuse of the drug discount program that ultimately harms patients. Joined with other patient advocate groups to comment on proposed rule: CMS-2390-P-Medicaid and Childrens Health Insurance Programs (CHIP); Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability. We supported the proposed rules intent to strengthen program integrity safeguards, and ensure beneficiary protections in areas of provider networks, coverage standards, and the treatment of appeals. We agree with the other groups that a modernized Medicaid managed care regulatory structure is essential to facilitate necessary system reform initiatives, and advance the delivery of health care for millions of people, and we supported rule changes to achieve those goals. RetireSafe joined with other patient advocates to comment on proposed rule: CMS-1631-P-Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY2016. In commenting we supported various measures for improving accuracy for primary care and care management services; providing appropriate advanced care planning services; providing better Medicare Telehealth services; providing better Chronic Care Management services for Rural Health Clinics and Qualified Health Centers; providing a useful Physicians Compare Website with data in proper context; and providing physician payment, efficiency, and quality improvements linked to a physician quality reporting system. RetireSafe joined with numerous patient groups to oppose a new CMS plan to cut the payment rate (from Average Sales Price plus 6%) for Medicare Part B Drugs administered by physicians in large parts of the U.S. because this Center for Medicare & Medicaid initiative focuses on costs rather than patients needs and health care quality. This new Part B Drug Plan will adversely impact Medicare patients with complex conditions such as cancer, macular degeneration, hypertension, rheumatoid arthritis, and primary immunodeficiency diseases. Along with many other patient advocates in the MAPRx Coalition, we strongly opposed a recent MedPAC effort to place Medicare cost savings ahead of the best interests of Medicare patients. Specifically, we urged MedPAC to reject proposals to make changes to true out-of-pocket costs (TrOOP); increase copays for low-income subsidy (LIS) beneficiaries; and eliminate any of the protected classes. RetireSafe joined with numerous patient groups to comment on the CMS Advance Notice and Draft Call Letter issued on February 19, 2016. The comments focused on better patient access to Medicare Part D Prescription Drugs and related specifically to: Specialty Tier Thresholds, Tier Labeling and Composition, Generic Tier $0 Copay Plans, Formulary Oversight, Drug Utilization Review Controls, Coverage Determination Timelines, and Access to Preferred Cost-sharing Pharmacies. RetireSafe has continued to work with a large number of patient groups (on several occasions) to strongly oppose the Centers for Medicare Services (CMS) Centers for Medicare and Medicaid Innovation (CMMI) March 8, 2016 proposed rule that would implement substantial changes to the Medicare Part B payment program. As we have stated in several joint letters to Members of Congress and to CMS, we believe the proposed changes which have been proposed as a demonstration project would impact some 75 percent of Medicare population and could limit access to the full range of available treatments under Part B to treat serious illnesses and medical treatments such as cancer, multiple sclerosis, primary immune deficiency, macular degeneration and schizophrenia. Unfortunately, the proposed program will be, in fact, mandatory for many physicians and their patients, and will cause patients to switch from the most appropriate treatment to less effective therapies or to forego treatment altogether because of transportation hurdles created by the new rule. RetireSafe also objects to the lack of sufficient stakeholder input from the beginning of this rule-making process, which has now created one-size-fits-all government payment policies that ignore patient differences and completely undermines the goal of patient-centered Medicare.

Client expense: — · Firm income: —

Matched citations: H.R. 2624

Support H.R. 3074, the CPI for Seniors Act of 2015.

Client expense: — · Firm income: —

Matched citations: H.R. 3074

Support H.R. 2362, the Medical Debt Relief Act. Commented to Support new United States Food and Drug Administration (FDA) efforts to ensure patient safety through the release of draft guidance entitled Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologic License Application. Joined with the I Am (Still) Essential Coalition to urge the Secretary of Health and Human Services (HHS) to ensure that the many patient protections included in the Notice of Benefit and Payment Parameters for 2016 and the Letter to Insurers are adhered to and strictly enforced as part of the 2016 upcoming Qualified Health Plan (QHP) review. Support the passage of H.R. 6, the 21st Century Cures Act. Joined with the Health IT Now Coalition in supporting the interoperability sections of H.R. 6, the 21st Century Cures Act. RetireSafe also specifically supported provisions in H.R. 6 designed to speed up the Advisory Committee on Immunization Practices (ACIP) process through an established timeline so that much-needed new vaccines can be approved for coverage and use. Joined with numerous patient advocate organizations to urge Congress to maintain a strong and secure patent system that recognizes the rights of legitimate patent owners and addresses the new forms of abuses that have emerged in both the courts and at the U.S. Patent & Trademark Office (PTO), especially in consideration of the critical nature of strong patent protection in the development of new therapies and treatments that could benefit millions of patients suffering with substantial unmet medical needs. RetireSafe supported maintaining 12 years of data exclusivity for biologic drugs under the Trans-Pacific Partnership (TTP) trade agreement as a key U.S. priority. With National Health Council, urged CMS to include accurate drug-specific out-of-pocket (OOP) costs in the proposed OOP cost estimator under development for the federally-facilitated marketplaces for the 2016 enrollment period. RetireSafe encouraged Members of Congress to hold a formal hearing to review FDA policy and guidance regarding the safe usage of biosimilar drugs. And, with other patient groups, advocated Risk Evaluation and Mitigation Strategies (REMS) and other rigorous safeguards to ensure the safe use of biosimilar drugs, especially for any federally mandated use. RetireSafe joined with 124 patient and community organizations to provide extensive comments on the Notice of Benefit and Payment Parameters for 2017 Proposed Rule, CMS 9937-P. Those comments included support for the proposed Standard Benefit Option (SBO) that will better enable consumers to compare plans and make informed choices. While we generally supported the SBO design, we expressed concern over the use of the Specialty Drug Tier and its use as a broad catch-all class insurers use to increase patient costs. We urged HHS to make all medications not subject to a deductible in all metal levels and tier levels, as we strongly believe that prescription medications should not be subject to a plans deductible. We also support the proposal that patient cost-sharing for most tiers and metal levels utilize reasonable cost-sharing, and oppose the use of coinsurance for the Specialty Drug Tier. We also repeated previous recommendations, and made some new ones that would better protect enrollees access to needed prescription drugs, in addition to recommendations that would better ensure critical continuity of care. In addition, RetireSafe joined with 197 patient and community organizations to comment on the Office for Civil Rights, ACA Non-discrimination Proposed Rule (RIN 0945-AA02). We were especially interested in one key ACA provision, Section 1557, which prohibits discrimination in the health care system on the basis of race, color, national origin, sex, age or disability. While we were pleased to see the long awaited proposed regulation to implement Sec. 1557 finally issued, we did not think the proposal went far enough in defining discriminatory practices in plan benefit design as it relates to all beneficiaries, particularly those with serious and chronic health conditions who rely on prescription medications and other health care services. We urged HHS to better define what discriminatory plan practices are in the final rule. RetireSafe also joined with a number of patient groups to again highlight in comments to HHS the importance of Nondiscrimination in Health-Related Insurance; the importance of the Designation of Responsible Employees and the Adoption of Grievance Procedures; and finally, that Notice Requirements require that covered entities consider the needs of all beneficiaries, so that they may be fully aware of their rights under the law. RetireSafe joined with 124 patient organizations in the I Am Essential coalition to voice strong support for the Obama Administrations proposed patient protections that health insurance companies must include as they develop their 2017 Qualified Health Plans (QHPs), and continued to call on the Administration to actually enforce those critical patient protections. While we are encouraged by repeated statements that plans cannot discriminate against patients by, for example, placing every drug to treat a certain condition on the highest cost-sharing tier, we have seen little evidence of actual enforcement. We supported the U.S. Senate version of the Medical Debt Relief Act (S. 2592). RetireSafe continues to join with other patient groups to urge the Food and Drug Administration (FDA) to require distinct, unique naming for any and all biosimilar drugs approved for use in the United States. We support the FDAs leadership in creating a system of distinguishable names for all biologic medicines, including biosimilars. This system recognizes the fact that biosimilars are not exact copies of their reference products, enhances patient safety and promotes pharmacovigilance. RetireSafe joined roughly 40 other patient groups to provide specific input to the Institute for Clinical and Economic Review (ICER) urging a patient-centric approach to ICERs ongoing assessment of value-based treatments. ICERs determinations impact the private (and to some degree public) health insurance landscape relative to which treatments are approved for use and reimbursement. RetireSafe believes the individual patient perspective must be the critical element of the ICER assessment process going forward.

Client expense: — · Firm income: —

Matched citations: H.R. 6

Joined with more than one hundred patient advocate organizations to urge Congress to amend H.R. 9 (the Innovation Act) to preserve important patent protections for the biopharmaceutical innovation needed to encourage cures and to develop therapies that will allow our respective patient communities to achieve a better quality of life. We urged the strongest patent protections to sustain and incentivize medical research.

Client expense: — · Firm income: —

Matched citations: H.R. 9

RetireSafe worked as a leader, along with other patient advocate groups, to oppose any new cuts to the Medicare Advantage payment rates for 2016. RetireSafe worked with the Medicare Access for Patients Rx Coalition (MAPRx) to raise concerns regarding the Advance Notice of Methodological Changes for Calendar Year 2016 for Medicare Advantage Capitation Rates, Part C and Part D Payment Policies and 2016 Call Letter to express concerns related to: the Exceptions and Appeals Process, Star Ratings and the Dual-Eligibles, Formulary Oversight, Drug Utilization Review Controls, Tier Labeling and Composition, Specialty Tiers, and the Use of Multiple Tiers with Coinsurance Cost-Sharing Rates. RetireSafe joined with the Medicare Rights Center and other patient advocates to urge numerous changes to the Medicare Part D Program to make the Exceptions and Appeals Processes More Accessible for Beneficiaries. RetireSafe joined with the Healthcare Leadership Council and others to support the Protecting Seniors Access to Medicare Act, (H.R. 1190 and S. 141) to repeal the Independent Payment Advisory Board (IPAB), authorized under the Patient Protection and Affordable Care Act. Support H.R. 2624 and S. 1488, the Part D Beneficiary Appeals Fairness Act. Support the passage of H.R. 160 to repeal the 2.3% Medical Device Tax. Support the passage of H.R. 1190 to repeal the Independent Payment Advisory Board (IPAB). Joined with the MAPRx coalition to urge Congress to build on the success of Medicare Part D to ensure robust formularies, coverage for the six-protected classes, strong oversight, and transparency for consumers, as well as add improvements to the process for notice of non-coverage, appeals and exceptions. Also, urged Part D remedies to correct gaps in coverage, onerous cost-shifting created by specialty tiers, and restrictive utilization management tools that severely reduce patient benefits. Support "340B" Medicaid program reform to end widespread abuse of the drug discount program that ultimately harms patients. Joined with other patient advocate groups to comment on proposed rule: CMS-2390-P-Medicaid and Childrens Health Insurance Programs (CHIP); Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability. We supported the proposed rules intent to strengthen program integrity safeguards, and ensure beneficiary protections in areas of provider networks, coverage standards, and the treatment of appeals. We agree with the other groups that a modernized Medicaid managed care regulatory structure is essential to facilitate necessary system reform initiatives, and advance the delivery of health care for millions of people, and we supported rule changes to achieve those goals. RetireSafe joined with other patient advocates to comment on proposed rule: CMS-1631-P-Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY2016. In commenting we supported various measures for improving accuracy for primary care and care management services; providing appropriate advanced care planning services; providing better Medicare Telehealth services; providing better Chronic Care Management services for Rural Health Clinics and Qualified Health Centers; providing a useful Physicians Compare Website with data in proper context; and providing physician payment, efficiency, and quality improvements linked to a physician quality reporting system. RetireSafe joined with numerous patient groups to oppose a new CMS plan to cut the payment rate (from Average Sales Price plus 6%) for Medicare Part B Drugs administered by physicians in large parts of the U.S. because this Center for Medicare & Medicaid initiative focuses on costs rather than patients needs and health care quality. This new Part B Drug Plan will adversely impact Medicare patients with complex conditions such as cancer, macular degeneration, hypertension, rheumatoid arthritis, and primary immunodeficiency diseases. Along with many other patient advocates in the MAPRx Coalition, we strongly opposed a recent MedPAC effort to place Medicare cost savings ahead of the best interests of Medicare patients. Specifically, we urged MedPAC to reject proposals to make changes to true out-of-pocket costs (TrOOP); increase copays for low-income subsidy (LIS) beneficiaries; and eliminate any of the protected classes. RetireSafe joined with numerous patient groups to comment on the CMS Advance Notice and Draft Call Letter issued on February 19, 2016. The comments focused on better patient access to Medicare Part D Prescription Drugs and related specifically to: Specialty Tier Thresholds, Tier Labeling and Composition, Generic Tier $0 Copay Plans, Formulary Oversight, Drug Utilization Review Controls, Coverage Determination Timelines, and Access to Preferred Cost-sharing Pharmacies. RetireSafe has continued to work with a large number of patient groups (on several occasions) to strongly oppose the Centers for Medicare Services (CMS) Centers for Medicare and Medicaid Innovation (CMMI) March 8, 2016 proposed rule that would implement substantial changes to the Medicare Part B payment program. As we have stated in several joint letters to Members of Congress and to CMS, we believe the proposed changes which have been proposed as a demonstration project would impact some 75 percent of Medicare population and could limit access to the full range of available treatments under Part B to treat serious illnesses and medical treatments such as cancer, multiple sclerosis, primary immune deficiency, macular degeneration and schizophrenia. Unfortunately, the proposed program will be, in fact, mandatory for many physicians and their patients, and will cause patients to switch from the most appropriate treatment to less effective therapies or to forego treatment altogether because of transportation hurdles created by the new rule. RetireSafe also objects to the lack of sufficient stakeholder input from the beginning of this rule-making process, which has now created one-size-fits-all government payment policies that ignore patient differences and completely undermines the goal of patient-centered Medicare.

Client expense: — · Firm income: —

Matched citations: S. 141

RetireSafe worked as a leader, along with other patient advocate groups, to oppose any new cuts to the Medicare Advantage payment rates for 2016. RetireSafe worked with the Medicare Access for Patients Rx Coalition (MAPRx) to raise concerns regarding the Advance Notice of Methodological Changes for Calendar Year 2016 for Medicare Advantage Capitation Rates, Part C and Part D Payment Policies and 2016 Call Letter to express concerns related to: the Exceptions and Appeals Process, Star Ratings and the Dual-Eligibles, Formulary Oversight, Drug Utilization Review Controls, Tier Labeling and Composition, Specialty Tiers, and the Use of Multiple Tiers with Coinsurance Cost-Sharing Rates. RetireSafe joined with the Medicare Rights Center and other patient advocates to urge numerous changes to the Medicare Part D Program to make the Exceptions and Appeals Processes More Accessible for Beneficiaries. RetireSafe joined with the Healthcare Leadership Council and others to support the Protecting Seniors Access to Medicare Act, (H.R. 1190 and S. 141) to repeal the Independent Payment Advisory Board (IPAB), authorized under the Patient Protection and Affordable Care Act. Support H.R. 2624 and S. 1488, the Part D Beneficiary Appeals Fairness Act. Support the passage of H.R. 160 to repeal the 2.3% Medical Device Tax. Support the passage of H.R. 1190 to repeal the Independent Payment Advisory Board (IPAB). Joined with the MAPRx coalition to urge Congress to build on the success of Medicare Part D to ensure robust formularies, coverage for the six-protected classes, strong oversight, and transparency for consumers, as well as add improvements to the process for notice of non-coverage, appeals and exceptions. Also, urged Part D remedies to correct gaps in coverage, onerous cost-shifting created by specialty tiers, and restrictive utilization management tools that severely reduce patient benefits. Support "340B" Medicaid program reform to end widespread abuse of the drug discount program that ultimately harms patients. Joined with other patient advocate groups to comment on proposed rule: CMS-2390-P-Medicaid and Childrens Health Insurance Programs (CHIP); Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability. We supported the proposed rules intent to strengthen program integrity safeguards, and ensure beneficiary protections in areas of provider networks, coverage standards, and the treatment of appeals. We agree with the other groups that a modernized Medicaid managed care regulatory structure is essential to facilitate necessary system reform initiatives, and advance the delivery of health care for millions of people, and we supported rule changes to achieve those goals. RetireSafe joined with other patient advocates to comment on proposed rule: CMS-1631-P-Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY2016. In commenting we supported various measures for improving accuracy for primary care and care management services; providing appropriate advanced care planning services; providing better Medicare Telehealth services; providing better Chronic Care Management services for Rural Health Clinics and Qualified Health Centers; providing a useful Physicians Compare Website with data in proper context; and providing physician payment, efficiency, and quality improvements linked to a physician quality reporting system. RetireSafe joined with numerous patient groups to oppose a new CMS plan to cut the payment rate (from Average Sales Price plus 6%) for Medicare Part B Drugs administered by physicians in large parts of the U.S. because this Center for Medicare & Medicaid initiative focuses on costs rather than patients needs and health care quality. This new Part B Drug Plan will adversely impact Medicare patients with complex conditions such as cancer, macular degeneration, hypertension, rheumatoid arthritis, and primary immunodeficiency diseases. Along with many other patient advocates in the MAPRx Coalition, we strongly opposed a recent MedPAC effort to place Medicare cost savings ahead of the best interests of Medicare patients. Specifically, we urged MedPAC to reject proposals to make changes to true out-of-pocket costs (TrOOP); increase copays for low-income subsidy (LIS) beneficiaries; and eliminate any of the protected classes. RetireSafe joined with numerous patient groups to comment on the CMS Advance Notice and Draft Call Letter issued on February 19, 2016. The comments focused on better patient access to Medicare Part D Prescription Drugs and related specifically to: Specialty Tier Thresholds, Tier Labeling and Composition, Generic Tier $0 Copay Plans, Formulary Oversight, Drug Utilization Review Controls, Coverage Determination Timelines, and Access to Preferred Cost-sharing Pharmacies. RetireSafe has continued to work with a large number of patient groups (on several occasions) to strongly oppose the Centers for Medicare Services (CMS) Centers for Medicare and Medicaid Innovation (CMMI) March 8, 2016 proposed rule that would implement substantial changes to the Medicare Part B payment program. As we have stated in several joint letters to Members of Congress and to CMS, we believe the proposed changes which have been proposed as a demonstration project would impact some 75 percent of Medicare population and could limit access to the full range of available treatments under Part B to treat serious illnesses and medical treatments such as cancer, multiple sclerosis, primary immune deficiency, macular degeneration and schizophrenia. Unfortunately, the proposed program will be, in fact, mandatory for many physicians and their patients, and will cause patients to switch from the most appropriate treatment to less effective therapies or to forego treatment altogether because of transportation hurdles created by the new rule. RetireSafe also objects to the lack of sufficient stakeholder input from the beginning of this rule-making process, which has now created one-size-fits-all government payment policies that ignore patient differences and completely undermines the goal of patient-centered Medicare.

Client expense: — · Firm income: —

Matched citations: S. 1488

Support H.R. 2362, the Medical Debt Relief Act. Commented to Support new United States Food and Drug Administration (FDA) efforts to ensure patient safety through the release of draft guidance entitled Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologic License Application. Joined with the I Am (Still) Essential Coalition to urge the Secretary of Health and Human Services (HHS) to ensure that the many patient protections included in the Notice of Benefit and Payment Parameters for 2016 and the Letter to Insurers are adhered to and strictly enforced as part of the 2016 upcoming Qualified Health Plan (QHP) review. Support the passage of H.R. 6, the 21st Century Cures Act. Joined with the Health IT Now Coalition in supporting the interoperability sections of H.R. 6, the 21st Century Cures Act. RetireSafe also specifically supported provisions in H.R. 6 designed to speed up the Advisory Committee on Immunization Practices (ACIP) process through an established timeline so that much-needed new vaccines can be approved for coverage and use. Joined with numerous patient advocate organizations to urge Congress to maintain a strong and secure patent system that recognizes the rights of legitimate patent owners and addresses the new forms of abuses that have emerged in both the courts and at the U.S. Patent & Trademark Office (PTO), especially in consideration of the critical nature of strong patent protection in the development of new therapies and treatments that could benefit millions of patients suffering with substantial unmet medical needs. RetireSafe supported maintaining 12 years of data exclusivity for biologic drugs under the Trans-Pacific Partnership (TTP) trade agreement as a key U.S. priority. With National Health Council, urged CMS to include accurate drug-specific out-of-pocket (OOP) costs in the proposed OOP cost estimator under development for the federally-facilitated marketplaces for the 2016 enrollment period. RetireSafe encouraged Members of Congress to hold a formal hearing to review FDA policy and guidance regarding the safe usage of biosimilar drugs. And, with other patient groups, advocated Risk Evaluation and Mitigation Strategies (REMS) and other rigorous safeguards to ensure the safe use of biosimilar drugs, especially for any federally mandated use. RetireSafe joined with 124 patient and community organizations to provide extensive comments on the Notice of Benefit and Payment Parameters for 2017 Proposed Rule, CMS 9937-P. Those comments included support for the proposed Standard Benefit Option (SBO) that will better enable consumers to compare plans and make informed choices. While we generally supported the SBO design, we expressed concern over the use of the Specialty Drug Tier and its use as a broad catch-all class insurers use to increase patient costs. We urged HHS to make all medications not subject to a deductible in all metal levels and tier levels, as we strongly believe that prescription medications should not be subject to a plans deductible. We also support the proposal that patient cost-sharing for most tiers and metal levels utilize reasonable cost-sharing, and oppose the use of coinsurance for the Specialty Drug Tier. We also repeated previous recommendations, and made some new ones that would better protect enrollees access to needed prescription drugs, in addition to recommendations that would better ensure critical continuity of care. In addition, RetireSafe joined with 197 patient and community organizations to comment on the Office for Civil Rights, ACA Non-discrimination Proposed Rule (RIN 0945-AA02). We were especially interested in one key ACA provision, Section 1557, which prohibits discrimination in the health care system on the basis of race, color, national origin, sex, age or disability. While we were pleased to see the long awaited proposed regulation to implement Sec. 1557 finally issued, we did not think the proposal went far enough in defining discriminatory practices in plan benefit design as it relates to all beneficiaries, particularly those with serious and chronic health conditions who rely on prescription medications and other health care services. We urged HHS to better define what discriminatory plan practices are in the final rule. RetireSafe also joined with a number of patient groups to again highlight in comments to HHS the importance of Nondiscrimination in Health-Related Insurance; the importance of the Designation of Responsible Employees and the Adoption of Grievance Procedures; and finally, that Notice Requirements require that covered entities consider the needs of all beneficiaries, so that they may be fully aware of their rights under the law. RetireSafe joined with 124 patient organizations in the I Am Essential coalition to voice strong support for the Obama Administrations proposed patient protections that health insurance companies must include as they develop their 2017 Qualified Health Plans (QHPs), and continued to call on the Administration to actually enforce those critical patient protections. While we are encouraged by repeated statements that plans cannot discriminate against patients by, for example, placing every drug to treat a certain condition on the highest cost-sharing tier, we have seen little evidence of actual enforcement. We supported the U.S. Senate version of the Medical Debt Relief Act (S. 2592). RetireSafe continues to join with other patient groups to urge the Food and Drug Administration (FDA) to require distinct, unique naming for any and all biosimilar drugs approved for use in the United States. We support the FDAs leadership in creating a system of distinguishable names for all biologic medicines, including biosimilars. This system recognizes the fact that biosimilars are not exact copies of their reference products, enhances patient safety and promotes pharmacovigilance. RetireSafe joined roughly 40 other patient groups to provide specific input to the Institute for Clinical and Economic Review (ICER) urging a patient-centric approach to ICERs ongoing assessment of value-based treatments. ICERs determinations impact the private (and to some degree public) health insurance landscape relative to which treatments are approved for use and reimbursement. RetireSafe believes the individual patient perspective must be the critical element of the ICER assessment process going forward.

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Matched citations: S. 2592

RetireSafe supports the Promoting Automotive Repair, Trade, and Sales (PARTS) Act (S. 560 and H.R. 1057).

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Matched citations: S. 560

RetireSafe supports the Promoting Automotive Repair, Trade, and Sales (PARTS) Act (S. 560 and H.R. 1057).

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Matched citations: H.R. 1057