Medical Debt Relief Act of 2016

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to Support new United States Food and Drug Administration (FDA) efforts to ensure patient safety through the release of draft guidance entitled Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologic License Application.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 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: Not reported · Firm income: $11,560

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

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.

Medical debt and credit scores. Medical Debt Relief Act - H.R. 2362, S 2592. Credit Repair Organizations Act - H.R. 347. Alternative scores for Fannie Mae and Freddie Mac - Credit Score Competition Act H.R. 4211. CFPB's Consumer complaint database - H.R. 5413, H.R. 5491. Data Security and Breach Notification - H.R.699, H.R. 4715, S 2659. Data Broker Accuracy of Collected Personal Information - H.R. 4516, H.R. 4517. Data Encryption. Military Lending Act and Department of Defense- Employment, Income and Status. Fraud Reduction and Data Analytics Act - S. 1233. CFPB - "Credit Invisibles" and the "unscoreable" - Consumers with a lack of credit history. CFPB - Use of arbitration agreements involving consumer financial products and services. CFPB - Short-term, small dollar lending. FIX Credit Reporting Errors Act - S. 1234. Stop Errors in Credit Use Reporting Act - S.1847. Alternative Credit Data - Telecom, utilities reporting consumer payment information to national credit bureaus. H.R. 4172. Credit Access and Inclusion. Equal Employment for All Act - Use of consumer credit for employment decisions. FCC Lifeline Program. Access to Credit Scores - H.R. 5010, H.R. 5058. Cybersecurity Threat Information Sharing - H.R. 1560. S. 2943 - National Defense Authorization Act. Removal of debt on a consumer credit report. FCRA and permissible purpose. S. 340 - Workforce Innovation and Opportunity Act (WIOA). Improper payments.

Client expense: $250,000 · Firm income: Not reported

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 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.

Medical debt and credit scores. Medical Debt Relief Act - H.R. 2362, S 2592. Credit Repair Organizations Act - H.R. 347. Alternative scores for Fannie Mae and Freddie Mac - Credit Score Competition Act H.R. 4211. CFPB's Consumer complaint database - H.R. 5413, H.R. 5491. Data Security and Breach Notification - H.R.699, H.R. 4715, S 2659. Data Broker Accuracy of Collected Personal Information - H.R. 4516, H.R. 4517. Data Encryption. Military Lending Act and Department of Defense- Employment, Income and Status. Fraud Reduction and Data Analytics Act - S. 1233. CFPB - "Credit Invisibles" and the "unscoreable" - Consumers with a lack of credit history. CFPB - Use of arbitration agreements involving consumer financial products and services. CFPB - Short-term, small dollar lending. FIX Credit Reporting Errors Act - S. 1234. Stop Errors in Credit Use Reporting Act - S.1847. Alternative Credit Data - Telecom, utilities reporting consumer payment information to national credit bureaus. H.R. 4172. Credit Access and Inclusion. Equal Employment for All Act - Use of consumer credit for employment decisions. FCC Lifeline Program. Access to Credit Scores - H.R. 5010, H.R. 5058. Cybersecurity Threat Information Sharing - H.R. 1560.

Client expense: $280,000 · Firm income: Not reported

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.

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 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.

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.

Medical debt and credit scores. Medical Debt Relief Act - H.R. 2362, S 2592. Credit Repair Organizations Act - H.R. 347. Alternative scores for Fannie Mae and Freddie Mac - Credit Score Competition Act H.R. 4211. CFPB's Consumer complaint database - H.R. 5413, H.R. 5491. Data Security and Breach Notification - H.R.699, H.R. 4715, S 2659. Data Broker Accuracy of Collected Personal Information - H.R. 4516, H.R. 4517. Data Encryption. Military Lending Act and Department of Defense- Employment, Income and Status. Improper Payments Coordination Act of 2015 - Do Not Pay Initiative - S 1073. Fraud Reduction and Data Analytics Act - S. 1233. CFPB - "Credit Invisibles" and the "unscoreable" - Consumers with a lack of credit history. CFPB - Use of arbitration agreements involving consumer financial products and services. CFPB - Short-term, small dollar lending. FIX Credit Reporting Errors Act - S. 1234. Stop Errors in Credit Use Reporting Act - S.1847. Alternative Credit Data - Telecom, utilities reporting consumer payment information to national credit bureaus. H.R. 3035. Credit Access and Inclusion. Housing Opportunity Through Modernization Act - H.R. 3700. Equal Employment for All Act - Use of consumer credit for employment decisions. FCC Lifeline Program - H.R. 4884. Access to Credit Scores - H.R. 5010, H.R. 5058. Protecting Veterans Credit - H.R. 5593.

Client expense: $280,000 · Firm income: Not reported

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 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).

Medical debt and credit scores. Medical Debt Relief Act - H.R. 2362, S 2592. Credit Repair Organizations Act - H.R. 347. Cybersecurity / Data security. Information sharing between public and private sectors - H.R. 4350. Alternative scores for Fannie Mae and Freddie Mac - Credit Score Competition Act H.R. 4211. CFPB's Consumer complaint database. Data Security and Breach Notification - H.R.699, H.R. 4715, H.R. 4516. Data Broker Accuracy of Collected Personal Information - H.R. 4516, H.R. 4517. Data Encryption. Military Lending Act and Department of Defense- Employment, Income and Status. Child Support Assistance Act - Child Support Enforcement Guidance - H.R. 22. Improper Payments Coordination Act of 2015 - Do Not Pay Initiative. Fraud Reduction and Data Analytics Act - S. 1233, H.R. 4180. CFPB - "Credit Invisibles" and the "unscoreable" - Consumers with a lack of credit history. CFPB - Use of arbitration agreements involving consumer financial products and services. CFPB - Short-term, small dollar lending. FIX Credit Reporting Errors Act - S. 1234. Stop Errors in Credit Use Reporting Act - S.1847. Alternative Credit Data - Telecom, utilities reporting consumer payment information to national credit bureaus. H.R. 3035. Credit Access and Inclusion. Housing Opportunity Through Modernization Act - H.R. 3700. Equal Employment for All Act - Use of consumer credit for employment decisions. Judicial Redress Act - EU Safe Harbor - H.R. 1428. FCC Lifeline Program - H.R. 4884.

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

FY 2017 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, funding for the National Institutes of Health, National Cancer Institute and Centers for Disease Control and Prevention relative to cancer screening, research and programs in FY 2017. FY 2016 omnibus spending package (P.L. 114-113), including $32 billion for medical research conducted and supported by the National Institutes of Health (NIH). National Cancer Moonshot Initiative, meeting to discuss services and research for cancer survivors. Endorsement of the Senate Medical Debt Relief Act (S.2592).

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

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of the Vice President of the United States, SENATE, White House Office

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).