Part D Beneficiary Appeals Fairness Act

Legislation to cut Medicare Part B Drug Reimbursement Raise awareness with legislators about the barriers to and the importance of protecting access for home dialysis. Pull through on Medicare demonstration to provide nursing services and supplies associated with home infusion of IVIG for patients with PIDD.HR 3613: Part D Beneficiary Appeals Fairness Act - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act, with respect to a prescription drug plan (PDP) that provides for any tiered cost-sharing within a formulary (including a structure that provides for different co-payment or coinsurance amounts for drugs in different tiers included within the formulary), to authorize a Medicare part D eligible individual enrolled in the plan to request an exception to the tiered cost-sharing structure. Medicare Part B Drug Reimbursement. H.R. 8 American Taxpayer Relief Act of 2012 -- working to mitigate the impact to kidney patients of the payment reductions required by the Act.

Client expense: $690,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation to cut Medicare Part B Drug Reimbursement Raise awareness with legislators about the barriers to and the importance of protecting access for home dialysis. Pull through on Medicare demonstration to provide nursing services and supplies associated with home infusion of IVIG for patients with PIDD.HR 3613: Part D Beneficiary Appeals Fairness Act - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act, with respect to a prescription drug plan (PDP) that provides for any tiered cost-sharing within a formulary (including a structure that provides for different co-payment or coinsurance amounts for drugs in different tiers included within the formulary), to authorize a Medicare part D eligible individual enrolled in the plan to request an exception to the tiered cost-sharing structure. Medicare Part B Drug Reimbursement. H.R. 8 American Taxpayer Relief Act of 2012 -- working to mitigate the impact to kidney patients of the payment reductions required by the Act.

Client expense: $720,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation to cut Medicare Part B Drug Reimbursement Raise awareness with legislators about the barriers to and the importance of protecting access for home dialysis.HR 3613: Part D Beneficiary Appeals Fairness Act - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act, with respect to a prescription drug plan (PDP) that provides for any tiered cost-sharing within a formulary (including a structure that provides for different co-payment or coinsurance amounts for drugs in different tiers included within the formulary), to authorize a Medicare part D eligible individual enrolled in the plan to request an exception to the tiered cost-sharing structure. Medicare Part B Drug Reimbursement.

Client expense: $1,111,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1845/S 960: Provide supplies and nursing services necessary for home infusion of IVIG to Medicare beneficiaries with Primary Immunodeficiency Diseases; Legislation to cut Medicare Part B Drug Reimbursement.Raise awareness with legislators about the barriers to and the importance of protecting access for home dialysis.HR 3613: Part D Beneficiary Appeals Fairness Act - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act, with respect to a prescription drug plan (PDP) that provides for any tiered cost-sharing within a formulary (including a structure that provides for different co-payment or coinsurance amounts for drugs in different tiers included within the formulary), to authorize a Medicare part D eligible individual enrolled in the plan to request an exception to the tiered cost-sharing structure.

Client expense: $660,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1845/S 960: Provide supplies and nursing services necessary for home infusion of IVIG to Medicare beneficiaries with Primary Immunodeficiency Diseases; Legislation to cut Medicare Part B Drug Reimbursement.Raise awareness with legislators about the barriers to and the importance of protecting access for home dialysis.HR 3613: Part D Beneficiary Appeals Fairness Act - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act, with respect to a prescription drug plan (PDP) that provides for any tiered cost-sharing within a formulary (including a structure that provides for different co-payment or coinsurance amounts for drugs in different tiers included within the formulary), to authorize a Medicare part D eligible individual enrolled in the plan to request an exception to the tiered cost-sharing structure.

Client expense: $820,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 891/S. 274: All provisions of the Medication Therapy Management Benefits Act of 2011; H.R. 905 /S. 733: All provisions of the legislation to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare; S. 31: All provisions of the Prescription Drug and Health Improvement Act of 2011; S. 44: All provisions of the Medicare Prescription Drug Price Negotiation Act of 2011 H.R. 999 / S. 560 - All provisions of the Medicare Prescription Drug Savings and Choice Act of 2011 Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, closing the Part D coverage gap Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, value-based insurance design, e-prescribing, PBM disclosure requirements, and medical loss ratio) Regulatory and proposed legislative changes to Medicare part D including EGWP waivers, MTM expansion, long term care short-term fills, recovery audit contractors Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs Regulatory Implementation of the HITECH Act FDA issues related to the Prescription Drug User Fee Act (PDUFA) (generic user fees, pedigree, REMs); implementation of approval pathway for generic biologic drugs 340b program H. R. 1290/S. 1206 - All provisions of The Medicare Prescription Savings Act Health care issues before the Joint Select Committee on Deficit Reduction H.R. 3613 the Part D Beneficiary Appeals Fairness Act S. 1356 / H.R. 3343 the Affordable Medicines Utilization Act H.R.4215 - All provisions of the Medicare Pharmacy Transparency and Fair Auditing Ac

Client expense: $559,998 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), SENATE

Support American Society of Consultant Pharmacists and "Short Cycle Dispensing Coalition" recommendations regarding the delay and study of new long-term care pharmacy dispensing rules and the impact of those rules on Medicare and Medicaid patients. Support H.R. 1055, the Part D Off-Label Prescription Drug Parity Act. Continue to oppose cuts to Medicare benefits, and continue to oppose the Independent Payment Advisory Board (IPAB). Support Medicare Access for Patients Rx (MAPRx) recommendations to Centers for Medicare and Medicaid Services (CMS) all regarding Medicare Part D. Those MAPRx recommendations are in regard to: Improved beneficiary protections; Better, more transparent Specialty Tier guidance including the threshold for inclusion on this tier and the inclusion of data for newly approved drugs; New, more realistic co-pay thresholds; Automatic disenrollment from Special Needs Plans; Proposed plan rating criteria; and Approval of six-tier formularies. These are in addition to MAPRx concerns regarding: The Part D Medicare appeals process and the handling of enrollee complaints; Drug dispensing rules for Part D beneficiaries in long-term care facilities; the Authority to deny bids and potential additional restrictions; and Compound Drug Policy. Support repeal of IPAB (H.R. 452). Support changes to the Medicare Shared Savings Program: Accountable Care Organization (ACO) proposed regulations, to provide additional safeguards to guarantee patient access to needed care, and to ensure that ACO's support the adoption of new treatments and cures for patients. Also support the addition of new Alzheimer's disease focused ACO quality measures, new ACO measures of provider evidence of competency in Geriatrics and Dementia, as well as a guarantee that Alzheimer's and Dementia patients under ACO care will have access to the newest pharmaceutical and biological treatments. Support repeal of Section 6001 of the PPACA and remove all restrictions on physician-owned hospitals. (Support H.R. 1159 and H.R. 1186) Oppose federal budget cuts that would increase co-payments for home health care services under Medicare and/or Medicaid Support the Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011 (S. 1096 and H.R. 2020) Support MAPRx suggestions to CMS on Medicare Part D Prescription Drug Program regarding new beneficiary-friendly point-of-sale notices that address problems in filling prescriptions and clear, instructive remedies for beneficiaries. Oppose proposals that would reduce payments to providers of drugs and biologics under Medicare Part B. Oppose proposals to increase Medicare Part D cost-sharing, raise Part D coinsurance, and/or freeze income thresholds. Oppose efforts to require Medicaid-type drug rebates from any Medicare Part D providers and all other kinds of mandated or negotiated Part D price controls that will harm beneficiaries and increase costs in other areas of Medicare. Support efforts to focus Medicare cost-saving efforts on eliminating improper payments, waste, fraud, and abuse first -- before cutting benefits, cutting payments to providers, or raising premium and coinsurance costs for beneficiaries. Support H.R. 3613 - Medicare Part D Beneficiary Appeals Fairness Act. Urged the "Super Committee" to resist proposals to erode beneficiary protections in Part D that ensure broad and accessible prescription drug formularies. Supported an extension of legislation to preserve access to osteoporosis testing for Medicare beneficiaries in the the final conference report on the Temporary Payroll Tax Cut Continuation Act of 2011 (H.R. 3630). Joined other patient advocate organizations to urge the National Government Services to to reconsider its policy regarding blanket denials under the Current Procedural Terminology (CPT) health and behavioral assessment and intervention codes (96150-96155) which restrict those medically appropriate services to Medicare beneficiaries with Alzheimer's disease. Support the MAPRx comments regarding the Draft 2013 Medicare Call Letter regarding proposed actions related to the Part D Prescription Drug Program. These included improved comments on beneficiary protections; Specialty Tiers; Co-pay Thresholds; Tier Labeling; Plan Rating Criteria; Medicare Therapy Management; and Drug Utilization Review Controls in Part D. Oppose Centers for Medicare and Medicaid Services (CMS) regulation that subjects dual-eligible Medicare/Medicaid beneficiaries to new state programs that may well diminish their Medicare protections and lessen their access to quality health care services. This includes passive enrollment into a managed care plan and disruptions to the continuity of care. Support "unique naming" requirements for all biologic drugs, especially biosimilar drugs, as a matter of patient safety. Support full Medicare funding for dual energy x-ray absorptiometry (DXA) test reimbursement to fight osteoporosis. Support new extended funding (as under the expired Medicare Improvements for Patients and Providers Act or MIPPA) for Medicare low-income outreach and enrollment activities. Support the Medicare Part D prescription drug benefit program and the needed improvements to correct its limitations; including gaps in coverage, onerous cost-shifting created by specialty tiers, and restrictive utilization management tools. Robust formularies, coverage of the six protected drug classes, strong oversight, and transparency for consumers are also critical, as is a process for notice of non-coverage, and an appeals and exceptions process that is patient and provider friendly. Support all measures making Alzheimer's disease a continued top priority at the U.S. Food and Drug Administration (FDA).

Client expense: $42,249 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Repeal Sustainable Growth Rate formula; Monitor implementation of P.L. 111-148; Extension of Section 3111, P.L. 111-148; H.R. 5707 Medicare Physician Payment Innovation Act; H.R. 2020 / S. 1096 Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act; H.R. 1700 / S. 1042 Medicare Patient Empowerment Act; H.R. 3613 Part D Beneficiary Appeals Fairness Act

Client expense: $100,000 · Firm income: Not reported

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

HR 1845/S 960: Provide supplies and nursing services necessary for home infusion of IVIG to Medicare beneficiaries with Primary Immunodeficiency Diseases; Legislation to cut Medicare Part B Drug Reimbursement.Raise awareness with legislators about the barriers to and the importance of protecting access for home dialysis. HR 3613: Part D Beneficiary Appeals Fairness Act - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act, with respect to a prescription drug plan (PDP) that provides for any tiered cost-sharing within a formulary (including a structure that provides for different co-payment or coinsurance amounts for drugs in different tiers included within the formulary), to authorize a Medicare part D eligible individual enrolled in the plan to request an exception to the tiered cost-sharing structure.

Client expense: $820,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Continues to advocate on HR 4378 - Ensuring Access to Quality Complex Rehabilitation Technology Act of 2012. This legislation creates a separate benefit for complex rehab technology under Medicare for individuals with significant disabilities and functional limitations. Discussed concerns and possible solutions to prior authorization and physician documentation matters regarding the submission of medical claims for Medicare beneficiaries and people with disabilities. Discussed concerns with the dual-eligible population regarding those who are individuals with disabilities and the availability of home and community-based services and supports. Supports HR 3613, Part D Beneficiary Appeal Fairness Act of 2011. This legislation resolves some of the concerns surrounding high-cost prescription drug coverage in the following ways: It would permit requests from beneficiaries for exceptions and appeals for all tiers in Medicare Part D tiers, including specialty tier drugs. It would prohibit insurance companies from blocking a more favorable cost-sharing structure as an outcome of the exceptions and appeals process decision. This legislation ensures that all Part D beneficiaries have access to an exceptions and appeals process if they find their medications unaffordable and prevents anyone from being at a disadvantage or subject to discrimination due to a specific condition. Supports HR 1546 and S. 829 - Medicare Access to Rehabilitation Services Act. This legislation would repeal the arbitrary Medicare Part B outpatient therapy caps now affecting an estimated 640,000 Medicare beneficiaries who depend on outpatient rehabiliation therapy. United Spinal advocated for lifting the cap on therapy and extending the exceptions process for beneficiaries that are in need of additional therapy and who have exceeded the cap. Supports HR 6490 - Medicare DMEPOS Market Pricing Program Act of 2012 replaces Medicare's current competitive bidding program under Medicare with a market pricing program for durable medical equipment. United Spinal supports changes to HHS' proposed rule entitled, Patient Protection and Affordable Care Act; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation. Section 1302(b) of the Affordable Care Act directs the Secretary of Health and Human Services (the Secretary) to define essential health benefits (EHB) which must include the following 10 benefit categories: (1) ambulatory patient services, (2) emergency services (3) hospitalization, (4) maternity and newborn care, (5) mental health and substance use disorder services, including behavioral health treatment, (6) prescription drugs, (7) rehabilitative and habilitative services and devices, (8) laboratory services, (9) preventive and wellness services and chronic disease management, and (10) pediatric services, including oral and vision care. Non-grandfathered plans in the individual and small group markets both inside and outside of the state insurance marketplaces, (known as the exchanges), certain Medicaid plans and other health programs must cover EHB beginning in 2014. United Spinal supports the need for greater clarity related to nondiscrimination regulations and state mandates and for more specificity and expanded coverage regarding habilitation, mental health and prescription drug benefits. In market reform comments to CMS, United Spinal supports the need for consumer protections against discrimination and adverse selection. Discussed possible solutions for improving access to Medicaid for military families who have children with disabilities. Advocated with Congress on the need to protect people with disabilities from additional cuts to Medicaid. United Spinal supports the following principles for an improved prescription drug benefit design over what currently exists under Medicare Part D: a robust formulary; required coverage for the six protected classes of drugs plus additional classes where there are unnecessary restrictions in place; appropriate oversight to the benefit; transparency on coverage and out-of-pocket costs; clear description of notice of non-coverage, appeals and exceptions process and rigorous oversight of medication utilization management tools (such as medication substitution, step therapy or quantity limits). Under Medicaid: Expand managed care where feasible to higher risk, higher cost beneficiaries and those dually eligible for Medicare with strict oversight and patient protections to improve care coordination and achieve efficiencies for these patients. Restore Medicaids discount prescription drug pricing to those dually eligible for Medicare. Under the state demonstrations to integrate care for dual-eligible individuals, urge CMS to establish and fund ombudsmen for each demonstration project, who would, at a minimum, provide: 1) information and assistance in pursuing complaints and appeals, 2) negotiation and mediation, 3) case advocacy assistance interpreting law, 4) reports on patterns of non-compliance, and 5) individual case advocacy in hearings and court proceedings related to benefits. United Spinal supports protecting Medicaid against future cuts. United Spinal opposes cuts to Medicaid provider taxes. Provider tax reductions would result in a cost shift to the states that could cause significant problems with state Medicaid budgets and restrictions on the provision of and access to healthcare. Other sustainable ways to address Medicaid costs should be investigated.

Client expense: $80,000 · Firm income: Not reported

Government targets: Defense, Dept of (DOD), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Housing & Urban Development, Dept of (HUD), Justice, Dept of (DOJ), Labor, Dept of (DOL), SENATE, Veterans Affairs, Dept of (VA), White House Office

HR 891/S 274 - legislation that would expand the existing medication therapy management program in Medicare Part D; S 31/S 44/HR 2248/HR 6392 - legislation taht would require or allow the federal government to negotiate prescription drug prices on behalf of Medicare Part D plan sponsors; HR 999/S 560 - legislation that would establish a nationwide Part D plan administered by the federal government; HR 1055 - legislation that would allow Part D plans to offer "off-label" coverage HR 2190/S 1206 - legislation that would require prescription drug manufacturers to pay Medicaid "best price" revates for covered prescription drugs purchased by dual eligibles under Medicare Part D; HR 3613 - legislation that would require Part D plans to establish an exceptions process for patient cost-sharing amounts; HR 4215 - legislation that would establish audit requirements and other transparency requirements for Part D plan sponsors; worked on proposed legislative language, which included consultation with Senate committee staff and discussions with personal staff of House and Senate members, that would amend the current prompt payment rules in Part D in the interest of preventing fraud.

Client expense: $170,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support American Society of Consultant Pharmacists and "Short Cycle Dispensing Coalition" recommendations regarding the delay and study of new long-term care pharmacy dispensing rules and the impact of those rules on Medicare and Medicaid patients. Support H.R. 1055, the Part D Off-Label Prescription Drug Parity Act. Continue to oppose cuts to Medicare benefits, and continue to oppose the Independent Payment Advisory Board (IPAB). Support Medicare Access for Patients Rx (MAPRx) recommendations to Centers for Medicare and Medicaid Services (CMS) all regarding Medicare Part D. Those MAPRx recommendations are in regard to: Improved beneficiary protections; Better, more transparent Specialty Tier guidance including the threshold for inclusion on this tier and the inclusion of data for newly approved drugs; New, more realistic co-pay thresholds; Automatic disenrollment from Special Needs Plans; Proposed plan rating criteria; and Approval of six-tier formularies. These are in addition to MAPRx concerns regarding: The Part D Medicare appeals process and the handling of enrollee complaints; Drug dispensing rules for Part D beneficiaries in long-term care facilities; the Authority to deny bids and potential additional restrictions; and Compound Drug Policy. Support repeal of IPAB (H.R. 452). Support changes to the Medicare Shared Savings Program: Accountable Care Organization (ACO) proposed regulations, to provide additional safeguards to guarantee patient access to needed care, and to ensure that ACO's support the adoption of new treatments and cures for patients. Also support the addition of new Alzheimer's disease focused ACO quality measures, new ACO measures of provider evidence of competency in Geriatrics and Dementia, as well as a guarantee that Alzheimer's and Dementia patients under ACO care will have access to the newest pharmaceutical and biological treatments. Support repeal of Section 6001 of the PPACA and remove all restrictions on physician-owned hospitals. (Support H.R. 1159 and H.R. 1186) Oppose federal budget cuts that would increase co-payments for home health care services under Medicare and/or Medicaid Support the Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011 (S. 1096 and H.R. 2020) Support MAPRx suggestions to CMS on Medicare Part D Prescription Drug Program regarding new beneficiary-friendly point-of-sale notices that address problems in filling prescriptions and clear, instructive remedies for beneficiaries. Oppose proposals that would reduce payments to providers of drugs and biologics under Medicare Part B. Oppose proposals to increase Medicare Part D cost-sharing, raise Part D coinsurance, and/or freeze income thresholds. Oppose efforts to require Medicaid-type drug rebates from any Medicare Part D providers and all other kinds of mandated or negotiated Part D price controls that will harm beneficiaries and increase costs in other areas of Medicare. Support efforts to focus Medicare cost-saving efforts on eliminating improper payments, waste, fraud, and abuse first -- before cutting benefits, cutting payments to providers, or raising premium and coinsurance costs for beneficiaries. Support H.R. 3613 - Medicare Part D Beneficiary Appeals Fairness Act. Urged the "Super Committee" to resist proposals to erode beneficiary protections in Part D that ensure broad and accessible prescription drug formularies. Supported an extension of legislation to preserve access to osteoporosis testing for Medicare beneficiaries in the the final conference report on the Temporary Payroll Tax Cut Continuation Act of 2011 (H.R. 3630). Joined other patient advocate organizations to urge the National Government Services to to reconsider its policy regarding blanket denials under the Current Procedural Terminology (CPT) health and behavioral assessment and intervention codes (96150-96155) which restrict those medically appropriate services to Medicare beneficiaries with Alzheimer's disease. Support the MAPRx comments regarding the Draft 2013 Medicare Call Letter regarding proposed actions related to the Part D Prescription Drug Program. These included improved comments on beneficiary protections; Specialty Tiers; Co-pay Thresholds; Tier Labeling; Plan Rating Criteria; Medicare Therapy Management; and Drug Utilization Review Controls in Part D. Oppose Centers for Medicare and Medicaid Services (CMS) regulation that subjects dual-eligible Medicare/Medicaid beneficiaries to new state programs that may well diminish their Medicare protections and lessen their access to quality health care services. This includes passive enrollment into a managed care plan and disruptions to the continuity of care. Support "unique naming" requirements for all biologic drugs, especially biosimilar drugs, as a matter of patient safety. Support full Medicare funding for dual energy x-ray absorptiometry (DXA) test reimbursement to fight osteoporosis. Support new extended funding (as under the expired Medicare Improvements for Patients and Providers Act or MIPPA) for Medicare low-income outreach and enrollment activities. Support the Medicare Part D prescription drug benefit program and the needed improvements to correct its limitations; including gaps in coverage, onerous cost-shifting created by specialty tiers, and restrictive utilization management tools. Robust formularies, coverage of the six protected drug classes, strong oversight, and transparency for consumers are also critical, as is a process for notice of non-coverage, and an appeals and exceptions process that is patient and provider friendly. Support all measures making Alzheimer's disease a continued top priority at the U.S. Food and Drug Administration (FDA).

Client expense: Not reported · Firm income: $6,710

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

General Medicare Protection, Prescription Drug Reimportation: H.R. 147 and S. 319; Medicare Prescription Drug Improvement: H.R. 3613; Waste and Fraud in Medicare: H.R. 3735, and H.Res. 666; Repeal of Sustainable Growth Rate: H.R. 5707.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 891/S. 274: All provisions of the Medication Therapy Management Benefits Act of 2011; H.R. 905 /S. 733: All provisions of the legislation to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare; S. 31: All provisions of the Prescription Drug and Health Improvement Act of 2011; S. 44: All provisions of the Medicare Prescription Drug Price Negotiation Act of 2011 H.R. 999 / S. 560 - All provisions of the Medicare Prescription Drug Savings and Choice Act of 2011 Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, closing the Part D coverage gap Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, value-based insurance design, e-prescribing, PBM disclosure requirements, and medical loss ratio) Regulatory and proposed legislative changes to Medicare part D including EGWP waivers, MTM expansion, long term care short-term fills, recovery audit contractors Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs Regulatory Implementation of the HITECH Act FDA issues related to the Prescription Drug User Fee Act (PDUFA) (generic user fees, pedigree, REMs); implementation of approval pathway for generic biologic drugs 340b program H. R. 1290/S. 1206 - All provisions of The Medicare Prescription Savings Act Health care issues before the Joint Select Committee on Deficit Reduction H.R. 3613 the Part D Beneficiary Appeals Fairness Act S. 1356 / H.R. 3343 the Affordable Medicines Utilization Act H.R.4215 - All provisions of the Medicare Pharmacy Transparency and Fair Auditing Act

Client expense: $518,430 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), SENATE

Support American Society of Consultant Pharmacists and "Short Cycle Dispensing Coalition" recommendations regarding the delay and study of new long-term care pharmacy dispensing rules and the impact of those rules on Medicare and Medicaid patients. Support H.R. 1055, the Part D Off-Label Prescription Drug Parity Act. Continue to oppose cuts to Medicare benefits, and continue to oppose the Independent Payment Advisory Board (IPAB). Support Medicare Access for Patients Rx (MAPRx) recommendations to Centers for Medicare and Medicaid Services (CMS) all regarding Medicare Part D. Those MAPRx recommendations are in regard to: Improved beneficiary protections; Better, more transparent Specialty Tier guidance including the threshold for inclusion on this tier and the inclusion of data for newly approved drugs; New, more realistic co-pay thresholds; Automatic disenrollment from Special Needs Plans; Proposed plan rating criteria; and Approval of six-tier formularies. These are in addition to MAPRx concerns regarding: The Part D Medicare appeals process and the handling of enrollee complaints; Drug dispensing rules for Part D beneficiaries in long-term care facilities; the Authority to deny bids and potential additional restrictions; and Compound Drug Policy. Support repeal of IPAB (H.R. 452). Support changes to the Medicare Shared Savings Program: Accountable Care Organization (ACO) proposed regulations, to provide additional safeguards to guarantee patient access to needed care, and to ensure that ACO's support the adoption of new treatments and cures for patients. Also support the addition of new Alzheimer's disease focused ACO quality measures, new ACO measures of provider evidence of competency in Geriatrics and Dementia, as well as a guarantee that Alzheimer's and Dementia patients under ACO care will have access to the newest pharmaceutical and biological treatments. Support repeal of Section 6001 of the PPACA and remove all restrictions on physician-owned hospitals. (Support H.R. 1159 and H.R. 1186) Oppose federal budget cuts that would increase co-payments for home health care services under Medicare and/or Medicaid Support the Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011 (S. 1096 and H.R. 2020) Support MAPRx suggestions to CMS on Medicare Part D Prescription Drug Program regarding new beneficiary-friendly point-of-sale notices that address problems in filling prescriptions and clear, instructive remedies for beneficiaries. Oppose proposals that would reduce payments to providers of drugs and biologics under Medicare Part B. Oppose proposals to increase Medicare Part D cost-sharing, raise Part D coinsurance, and/or freeze income thresholds. Oppose efforts to require Medicaid-type drug rebates from any Medicare Part D providers and all other kinds of mandated or negotiated Part D price controls that will harm beneficiaries and increase costs in other areas of Medicare. Support efforts to focus Medicare cost-saving efforts on eliminating improper payments, waste, fraud, and abuse first -- before cutting benefits, cutting payments to providers, or raising premium and coinsurance costs for beneficiaries. Support H.R. 3613 - Medicare Part D Beneficiary Appeals Fairness Act. Urged the "Super Committee" to resist proposals to erode beneficiary protections in Part D that ensure broad and accessible prescription drug formularies. Supported an extension of legislation to preserve access to osteoporosis testing for Medicare beneficiaries in the the final conference report on the Temporary Payroll Tax Cut Continuation Act of 2011 (H.R. 3630). Joined other patient advocate organizations to urge the National Government Services to to reconsider its policy regarding blanket denials under the Current Procedural Terminology (CPT) health and behavioral assessment and intervention codes (96150-96155) which restrict those medically appropriate services to Medicare beneficiaries with Alzheimer's disease. Support the MAPRx comments regarding the Draft 2013 Medicare Call Letter regarding proposed actions related to the Part D Prescription Drug Program. These included improved comments on beneficiary protections; Specialty Tiers; Co-pay Thresholds; Tier Labeling; Plan Rating Criteria; Medicare Therapy Management; and Drug Utilization Review Controls in Part D. Oppose Centers for Medicare and Medicaid Services (CMS) regulation that subjects dual-eligible Medicare/Medicaid beneficiaries to new state programs that may well diminish their Medicare protections and lessen their access to quality health care services. This includes passive enrollment into a managed care plan and disruptions to the continuity of care.

Client expense: $75,187 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Repeal Sustainable Growth Rate formula; H.R. 452 Medicare Decisions Accountability Act; H.R. 2020 / S. 1096 Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act; H.R. 1700 / S. 1042 Medicare Patient Empowerment Act; H.R. 3613 Part D Beneficiary Appeals Fairness Act; H.R. 5707 Medicare Physician Payment Innovation Act; H.R. 6142 Assuring Medicare Stability and Access for Seniors Act; Monitor implementation of P.L. 111-148; Extension of Section 3111, P.L. 111-148

Client expense: $120,000 · Firm income: Not reported

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

HR 1845/S 960: Provide supplies and nursing services necessary for home infusion of IVIG to Medicare beneficiaries with Primary Immunodeficiency Diseases; Legislation to cut Medicare Part B Drug Reimbursement.Raise awareness with legislators about the barriers to and the importance of protecting access for home dialysis. HR 3613: Part D Beneficiary Appeals Fairness Act - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act, with respect to a prescription drug plan (PDP) that provides for any tiered cost-sharing within a formulary (including a structure that provides for different co-payment or coinsurance amounts for drugs in different tiers included within the formulary), to authorize a Medicare part D eligible individual enrolled in the plan to request an exception to the tiered cost-sharing structure.

Client expense: $460,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 891 and S 274 - legislation that would expand the existing medication therapy management program in Medicare Part D; S 31 and S 44 and HR 2248 and HR 3638 - legislation that would require or allow the federal government to negotiate prescription drug prices on behalf of Medicare Part D plan sponsors; HR 999 and S 560 - legislation that would establish a nationwide Part D plan administered by the federal government; HR 1055 - legislation that would allow Part D plan sponsors to offer "off-label" coverage HR 2190 and S 1206 - legislation that would require prescription drug manufacturers to pay Medicaid "best price" rebates for covered prescription drugs purchased by dual eligibles under Medicare Part D; HR 3613 - legislation that would require Medicare Part D plans to establish an exceptions process for patient cost-sharing amounts; HR 4215 - legislation that would establish audit requirements and other transparency requirements for Medicare part D plan sponsors; HR 6392 - legislation that would allow the federal government to negotiate prescription drug prices on behalf of Medicare Part D plan sponsors; Worked on proposed legislative language, work which included consultation with Senate committee staff, that would amend the current prompt payment rules in Medicare Part D in the interest of preventing fraud.

Client expense: $170,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Continues to educate Congress on HR 4378 - Ensuring Access to Quality Complex Rehabilitation Technology Act of 2012. This legislation creates a separate benefit for complex rehab technology under Medicare for individuals with significant disabilities and functional limitations. Discussed possible solutions for improving access to Medicaid for military families who have children with disabilities. Discussed concerns and possible solutions to prior authorization and physician documentation matters regarding the submission of medical claims for Medicare beneficiaries and people with disabilities. Discussed concerns with the dual-eligible population regarding those who are individuals with disabilities and the avaialability of home and community-base services and supports. Discussed our concerns and possible solutions around Medicare caps on rehabilitation therapy for individuals with disabilities. Supports HR 3613, Part D Beneficiary Appeal Fairness Act of 2011. This legislation resolves some of the concerns surrounding high-cost prescription drug coverage in the following ways: It would permit requests from beneficiaries for exceptions and appeals for all tiers in Medicare Part D tiers, including specialty tier drugs. It would prohibit insurance companies from blocking a more favorable cost-sharing structure as an outcome of the exceptions and appeals process decision. This legislation ensures that all Part D beneficiaries have access to an exceptions and appeals process if they find their medications unaffordable and prevents anyone from being at a disadvantage or subject to discrimination due to a specific condition. Supports HR 1546 and S. 829 - the Medicare Access to Rehabilitation Services Act. This legislation would repeal the arbitrary Medicare Part B outpatient therapy caps now affecting an estimated 640,000 Medicare beneficiaries who depend on outpatient rehabiliation therapy. Under Medicaid: Expand managed care where feasible to higher risk, higher cost beneficiaries and those dually eligible for Medicare with strict oversight and patient protections to improve care coordination and achieve efficiencies for these patients. Restore Medicaids discount prescription drug pricing to those dually eligible for Medicare.

Client expense: $70,000 · Firm income: Not reported

Government targets: Defense, Dept of (DOD), Education, Dept of, HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Housing & Urban Development, Dept of (HUD), Justice, Dept of (DOJ), SENATE, Veterans Affairs, Dept of (VA)

Support American Society of Consultant Pharmacists and "Short Cycle Dispensing Coalition" recommendations regarding the delay and study of new long-term care pharmacy dispensing rules and the impact of those rules on Medicare and Medicaid patients. Support H.R. 1055, the Part D Off-Label Prescription Drug Parity Act. Continue to oppose cuts to Medicare benefits, and continue to oppose the Independent Payment Advisory Board (IPAB). Support Medicare Access for Patients Rx (MAPRx) recommendations to Centers for Medicare and Medicaid Services (CMS) all regarding Medicare Part D. Those MAPRx recommendations are in regard to: Improved beneficiary protections; Better, more transparent Specialty Tier guidance including the threshold for inclusion on this tier and the inclusion of data for newly approved drugs; New, more realistic co-pay thresholds; Automatic disenrollment from Special Needs Plans; Proposed plan rating criteria; and Approval of six-tier formularies. These are in addition to MAPRx concerns regarding: The Part D Medicare appeals process and the handling of enrollee complaints; Drug dispensing rules for Part D beneficiaries in long-term care facilities; the Authority to deny bids and potential additional restrictions; and Compound Drug Policy. Support repeal of IPAB (H.R. 452). Support changes to the Medicare Shared Savings Program: Accountable Care Organization (ACO) proposed regulations, to provide additional safeguards to guarantee patient access to needed care, and to ensure that ACO's support the adoption of new treatments and cures for patients. Also support the addition of new Alzheimer's disease focused ACO quality measures, new ACO measures of provider evidence of competency in Geriatrics and Dementia, as well as a guarantee that Alzheimer's and Dementia patients under ACO care will have access to the newest pharmaceutical and biological treatments. Support repeal of Section 6001 of the PPACA and remove all restrictions on physician-owned hospitals. (Support H.R. 1159 and H.R. 1186) Oppose federal budget cuts that would increase co-payments for home health care services under Medicare and/or Medicaid Support the Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011 (S. 1096 and H.R. 2020) Support MAPRx suggestions to CMS on Medicare Part D Prescription Drug Program regarding new beneficiary-friendly point-of-sale notices that address problems in filling prescriptions and clear, instructive remedies for beneficiaries. Oppose proposals that would reduce payments to providers of drugs and biologics under Medicare Part B. Oppose proposals to increase Medicare Part D cost-sharing, raise Part D coinsurance, and/or freeze income thresholds. Oppose efforts to require Medicaid-type drug rebates from any Medicare Part D providers and all other kinds of mandated or negotiated Part D price controls that will harm beneficiaries and increase costs in other areas of Medicare. Support efforts to focus Medicare cost-saving efforts on eliminating improper payments, waste, fraud, and abuse first -- before cutting benefits, cutting payments to providers, or raising premium and coinsurance costs for beneficiaries. Support H.R. 3613 - Medicare Part D Beneficiary Appeals Fairness Act. Urged the "Super Committee" to resist proposals to erode beneficiary protections in Part D that ensure broad and accessible prescription drug formularies. Supported an extension of legislation to preserve access to osteoporosis testing for Medicare beneficiaries in the the final conference report on the Temporary Payroll Tax Cut Continuation Act of 2011 (H.R. 3630). Joined other patient advocate organizations to urge the National Government Services to to reconsider its policy regarding blanket denials under the Current Procedural Terminology (CPT) health and behavioral assessment and intervention codes (96150-96155) which restrict those medically appropriate services to Medicare beneficiaries with Alzheimer's disease. Support the MAPRx comments regarding the Draft 2013 Medicare Call Letter regarding proposed actions related to the Part D Prescription Drug Program. These included improved comments on beneficiary protections; Specialty Tiers; Co-pay Thresholds; Tier Labeling; Plan Rating Criteria; Medicare Therapy Management; and Drug Utilization Review Controls in Part D. Oppose Centers for Medicare and Medicaid Services (CMS) regulation that subjects dual-eligible Medicare/Medicaid beneficiaries to new state programs that may well diminish their Medicare protections and lessen their access to quality health care services. This includes passive enrollment into a managed care plan and disruptions to the continuity of care.

Client expense: Not reported · Firm income: $9,625

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

General Medicare Protection, Prescription Drug Reimportation: H.R. 147 and S. 319; Medicare Prescription Drug Improvement: H.R. 3613; Waste and Fraud in Medicare: H.R. 3735 and H.Res. 666; Repeal of Sustainable Growth Rate: H.R. 5707.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Repeal Sustainable Growth Rate formula; H.R. 5707 Medicare Physician Payment Innovation Act; H.R. 3613 Part D Beneficiary Appeals Fairness Act; H.R. 452 Medicare Decisions Accountability Act; S. 1042 / H.R. 1700 Medicare Patient Empowerment Act; H.R. 3399 Medicare and Medicaid FAST Act; S. 1096 / H.R. 2020 Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act; Monitor implementation of P.L. 111-148; Extension of Section 3111 of P.L. 111-148

Client expense: $90,000 · Firm income: Not reported

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

HR 4378 - Ensuring Access to Quality Complex Rehabiliation Technology Act of 2012. Throughout the second quarter, 2012, United Spinal has been advocating on this legislation to create a separate benefit category in Medicare for coverage of complex rehabilitation technology such as highly sophisticated, customized power mobility devices. The bill entails a broader baseline of services than those that are currently referred to under the Medicare program as durable medical equipment. HR 4378 ensures access to appropriate prodcuts and technology based on a person's functional needs in addition to their diagnosis and the severity of their injury or disorder; allows individuals to access devices that can be used outside of the home and in the community, allows individuals to work and participate in community life; and, ensuring access to local CRT suppliers equipped to make repairs and maintenance for specialized devices. United Spinal Association wrote a letter in April to Secretary Sebelius applauding the newly created Administration for Community Living (ACL) in support of the focus on community living and urged the agency to lift the outdated rule that ties Medicare coverage of wheelchairs and other mobility assistive equipment to in-the-home use. United Spinal also met with the ACL to discuss complex rehab technology and Medicaid managed care and there will be a continuing dialogue between the Association and the ACL on these and other matters. In April, United Spinal submitted comments to the Centers for Medicare and Medicaid Services in response to the proposed information collection requirements for the Medicare prior authorization demonstration applied to coverage claims for power mobility devices. We insisted that CMS be proactive in providing guidance, in the form of guides or templates, to assist physicians and treating practitioners in filing claims and documenting medical necessity and functional limitations from the outset. In June comments to the Office of Management and Budget, we continue to urge the creation of an electronic template under this demonstration to help accelerate the delivery of necessary equipment that will enhance mobility-related activities of daily living and support the independendce of individuals with disabilities. In April, United Spinal signed onto a letter to the Food and Drug Administration's Center for Devices and Radiological Health on the Medical Device User Fee and Modernization Act (MDUFA) agreement in principle between industry and FDA (Docket No. FDA-2010-N-0389). The letter supports the agency-industry agreements intent to do the following: significantly improve FDA review times to help speed up safe and effective treatments to patients; vastly enhance the consistency and timeliness of the approval process, helping to provide patients more information and certainty about the process; offer greater accountability and improved transparency resulting in more data points on FDAs performance; provide enhanced resources to give FDA the necessary tools for meeting new performance goals. Medicaid Eligibility Rules United Spinal co-signed a Consortium for Citizens with Disabilities letter to HHS Secretary Kathleen Sebelius, spearheaded by the Healthcare for America Now coalition urging the Centers for Medicare & Medicaid Services (CMS) to reconsider the provision of the final Medicaid rule (CMS-2349-F) that permits important eligibility determination functions to be contracted to private entities. Public accountability for Medicaid eligibility determinations is essential. The best way to ensure accountability is if governmental staff carries out these functions in the best interest of the public, free of bias or conflicts of interest. This has been the policy in Medicaid for decades: to change it without a process for notice and comment would be highly unusual and set a bad precedent. Congressional Hearing on Competitive Acquisition United Spinal Association submitted a statement for the record to the United States House Committee on Ways and Means Subcommittee on Health. United Spinal urged the committee to look closely at how the Centers for Medicare and Medicaid Services is gathering data on the impact this program has on all consumers, including people with disabilities. United Spinal Association will continue to monitor how the program is impacting consumers. United Spinal signed onto a Coalition for Disability Health Equity letter to CMS in response to the agencys proposed rules on the agency's electronic health record incentive program. Health information technology and electronic health records have the power to collect aggregated data on people with disabilities to provide information to improve the quality of care of all people with disabilities. The incentive program offers an important opportunity to reduce health disparities and improve equity in the U.S. health care system. Reducing disparities is included in the first of the five pillars of meaningful use health outcomes policy priorities and health disparities among those with disabilities are included in HHS policies to reduce health disparities, including Healthy People 2020 and the Affordable Care Act. Supported reauthorization of the Traumatic Brain Injury Act. This is the only federal legislation that specifically assists states and other entities to develop and expand service delivery systems, and provide needed advocacy to meet the needs and protect the rights of individuals who have sustained a TBI and their families. HR 3613: Part D Beneficairy Appeal Fairness Act which supports implementation of a fair and reasonable exceptions and appeals process under Medicare Part D coverage for seniors and people with disabilities that depend on 'specialty tier' drugs to improve or maintain their health status and function. Support making the Medicaid Buy In program mandatory nationwide. To maintain their capacity for employment that keeps them off the Medicaid rolls, workers with disabilities often need long-term services and supports. In many states, they are able to purchase affordable Medicaid coverage for this purpose but the benefits vary. To promote the productivity and independence of workers with disabilities, Medicaid buy-in coverage should be made consistent in scope, remain affordable and offered for purchase in all states. Request that DOL issue the Rehab Act Section 503 Final Rules governing Federal Contractor compliance with measurable affirmative action goals for recruiting, hiring and advancing workers with disabilities. Federal contractors and subcontractors account for one-fifth of all jobs in the employment marketplace. It is critical that they be held accountable to the law. HR 1546 and S 829, the Medicare Access to Rehabilitation Services Act which eliminates Medicare Part Bs arbitrary and unfair outpatient rehab therapy payment caps. Advance the use of home and community-based services and supports as mandatory long-term care benefits (currently optional to the states) which are far less costly than nursing home and other facility-based care for such purposes and are currently mandatory under Medicaid. Expand managed care where feasible to higher risk, higher cost beneficiaries and those dually eligible for Medicare as well with strict oversight and patient protections to improve care coordination and achieve efficiencies for these patients. Restore Medicaids discount prescription drug pricing to those dually eligible for Medicare. Intensify efforts to reduce fraud and abuse which accounted for $12.9 billion in Medicaid improper payments in FY 2007. Insist that Medicare restore its pre-2008 catheter policy language around individual consideration that enabled physicians to diagnose and prescribe the proper treatment based on their patients specific needs, circumstances and risk factors. Add a new criterion for Medicare eligibility for a closed system catheter that allows automatic qualification for patients with permanent severe bladder impairments, reducing their risk of bacterial contamination which can lead to life-threatening UTIs.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Housing & Urban Development, Dept of (HUD), Justice, Dept of (DOJ), Labor, Dept of (DOL), SENATE, Veterans Affairs, Dept of (VA)

General Medicare Protection Prescription Reimportation HR 147 and S 319; Medicare Prescription Drug Improvement HR 3613; Waste and Fraud in Medicare HR 3735 and H.Res 666; Repeal of Sustainable Growth Rate: HR 5707

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 891 and S 274 - legislation that would expand the existing medication therapy management program in Medicare Part D; S 31 and S 44 and HR 2248 and HR 3638 - legislation that would require or allow the federal government to negotiate prescription drug prices on behalf of Medicare Part D plan sponsors; HR 999 and S 560 - legislation that would establish a nationwide Part D plan administered by the federal government; HR 1055 - legislation that would allow Part D plan sponsors to offer "off-label" coverage HR 2190 and S 1206 - legislation that would require prescription drug manufacturers to pay Medicaid "best price" rebates for covered prescription drugs purchased by dual eligibles under Medicare Part D; HR 3613 - legislation that would require Medicare Part D plans to establish an exceptions process for patient cost-sharing amounts; HR 4215 - legislation that would establish audit requirements and other transparency requirements for Medicare part D plan sponsors; Worked on proposed legislative language, work which included consultation with Senate committee staff, that would amend the current prompt payment rules in Medicare Part D in the interest of preventing fraud.

Client expense: $150,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 891/S. 274: All provisions of the Medication Therapy Management Benefits Act of 2011; H.R. 905 /S. 733: All provisions of the legislation to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare; S. 31: All provisions of the Prescription Drug and Health Improvement Act of 2011; S. 44: All provisions of the Medicare Prescription Drug Price Negotiation Act of 2011 H.R. 999 / S. 560 - All provisions of the Medicare Prescription Drug Savings and Choice Act of 2011 Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, closing the Part D coverage gap Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, value-based insurance design, e-prescribing, PBM disclosure requirements, and medical loss ratio) Regulatory and proposed legislative changes to Medicare part D including EGWP waivers, MTM expansion, long term care short-term fills, recovery audit contractors Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs Regulatory Implementation of the HITECH Act FDA issues related to the Prescription Drug User Fee Act (PDUFA) (generic user fees, pedigree, REMs); implementation of approval pathway for generic biologic drugs 340b program H. R. 1290/S. 1206 - All provisions of The Medicare Prescription Savings Act Health care issues before the Joint Select Committee on Deficit Reduction H.R. 3613 the Part D Beneficiary Appeals Fairness Act S. 1356 / H.R. 3343 the Affordable Medicines Utilization Act H.R.4215 - All provisions of the Medicare Pharmacy Transparency and Fair Auditing Act

Client expense: $520,389 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), SENATE

Support American Society of Consultant Pharmacists and "Short Cycle Dispensing Coalition" recommendations regarding the delay and study of new long-term care pharmacy dispensing rules and the impact of those rules on Medicare and Medicaid patients. Support H.R. 1055, the Part D Off-Label Prescription Drug Parity Act. Continue to oppose cuts to Medicare benefits, and continue to oppose the Independent Payment Advisory Board (IPAB). Support Medicare Access for Patients Rx (MAPRx) recommendations to Centers for Medicare and Medicaid Services (CMS) all regarding Medicare Part D. Those MAPRx recommendations are in regard to: Improved beneficiary protections; Better, more transparent Specialty Tier guidance including the threshold for inclusion on this tier and the inclusion of data for newly approved drugs; New, more realistic co-pay thresholds; Automatic disenrollment from Special Needs Plans; Proposed plan rating criteria; and Approval of six-tier formularies. These are in addition to MAPRx concerns regarding: The Part D Medicare appeals process and the handling of enrollee complaints; Drug dispensing rules for Part D beneficiaries in long-term care facilities; the Authority to deny bids and potential additional restrictions; and Compound Drug Policy. Support repeal of IPAB (H.R. 452). Support changes to the Medicare Shared Savings Program: Accountable Care Organization (ACO) proposed regulations, to provide additional safeguards to guarantee patient access to needed care, and to ensure that ACO's support the adoption of new treatments and cures for patients. Also support the addition of new Alzheimer's disease focused ACO quality measures, new ACO measures of provider evidence of competency in Geriatrics and Dementia, as well as a guarantee that Alzheimer's and Dementia patients under ACO care will have access to the newest pharmaceutical and biological treatments. Support repeal of Section 6001 of the PPACA and remove all restrictions on physician-owned hospitals. (Support H.R. 1159 and H.R. 1186) Oppose federal budget cuts that would increase co-payments for home health care services under Medicare and/or Medicaid Support the Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011 (S. 1096 and H.R. 2020) Support MAPRx suggestions to CMS on Medicare Part D Prescription Drug Program regarding new beneficiary-friendly point-of-sale notices that address problems in filling prescriptions and clear, instructive remedies for beneficiaries. Oppose proposals that would reduce payments to providers of drugs and biologics under Medicare Part B. Oppose proposals to increase Medicare Part D cost-sharing, raise Part D coinsurance, and/or freeze income thresholds. Oppose efforts to require Medicaid-type drug rebates from any Medicare Part D providers and all other kinds of mandated or negotiated Part D price controls that will harm beneficiaries and increase costs in other areas of Medicare. Support efforts to focus Medicare cost-saving efforts on eliminating improper payments, waste, fraud, and abuse first -- before cutting benefits, cutting payments to providers, or raising premium and coinsurance costs for beneficiaries. Support H.R. 3613 - Medicare Part D Beneficiary Appeals Fairness Act. Urged the "Super Committee" to resist proposals to erode beneficiary protections in Part D that ensure broad and accessible prescription drug formularies. Supported an extension of legislation to preserve access to osteoporosis testing for Medicare beneficiaries in the the final conference report on the Temporary Payroll Tax Cut Continuation Act of 2011 (H.R. 3630). Joined other patient advocate organizations to urge the National Government Services to to reconsider its policy regarding blanket denials under the Current Procedural Terminology (CPT) health and behavioral assessment and intervention codes (96150-96155) which restrict those medically appropriate services to Medicare beneficiaries with Alzheimer's disease. Support the MAPRx comments regarding the Draft 2013 Medicare Call Letter regarding proposed actions related to the Part D Prescription Drug Program. These included improved comments on beneficiary protections; Specialty Tiers; Co-pay Thresholds; Tier Labeling; Plan Rating Criteria; Medicare Therapy Management; and Drug Utilization Review Controls in Part D. Oppose Centers for Medicare and Medicaid Services (CMS) regulation that subjects dual-eligible Medicare/Medicaid beneficiaries to new state programs that may well diminish their Medicare protections and lessen their access to quality health care services. This includes passive enrollment into a managed care plan and disruptions to the continuity of care.

Client expense: Not reported · Firm income: $10,808

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Support American Society of Consultant Pharmacists and "Short Cycle Dispensing Coalition" recommendations regarding the delay and study of new long-term care pharmacy dispensing rules and the impact of those rules on Medicare and Medicaid patients. Support H.R. 1055, the Part D Off-Label Prescription Drug Parity Act. Continue to oppose cuts to Medicare benefits, and continue to oppose the Independent Payment Advisory Board (IPAB). Support Medicare Access for Patients Rx (MAPRx) recommendations to Centers for Medicare and Medicaid Services (CMS) all regarding Medicare Part D. Those MAPRx recommendations are in regard to: Improved beneficiary protections; Better, more transparent Specialty Tier guidance including the threshold for inclusion on this tier and the inclusion of data for newly approved drugs; New, more realistic co-pay thresholds; Automatic disenrollment from Special Needs Plans; Proposed plan rating criteria; and Approval of six-tier formularies. These are in addition to MAPRx concerns regarding: The Part D Medicare appeals process and the handling of enrollee complaints; Drug dispensing rules for Part D beneficiaries in long-term care facilities; the Authority to deny bids and potential additional restrictions; and Compound Drug Policy. Support repeal of IPAB (H.R. 452). Support changes to the Medicare Shared Savings Program: Accountable Care Organization (ACO) proposed regulations, to provide additional safeguards to guarantee patient access to needed care, and to ensure that ACO's support the adoption of new treatments and cures for patients. Also support the addition of new Alzheimer's disease focused ACO quality measures, new ACO measures of provider evidence of competency in Geriatrics and Dementia, as well as a guarantee that Alzheimer's and Dementia patients under ACO care will have access to the newest pharmaceutical and biological treatments. Support repeal of Section 6001 of the PPACA and remove all restrictions on physician-owned hospitals. (Support H.R. 1159 and H.R. 1186) Oppose federal budget cuts that would increase co-payments for home health care services under Medicare and/or Medicaid Support the Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011 (S. 1096 and H.R. 2020) Support MAPRx suggestions to CMS on Medicare Part D Prescription Drug Program regarding new beneficiary-friendly point-of-sale notices that address problems in filling prescriptions and clear, instructive remedies for beneficiaries. Oppose proposals that would reduce payments to providers of drugs and biologics under Medicare Part B. Oppose proposals to increase Medicare Part D cost-sharing, raise Part D coinsurance, and/or freeze income thresholds. Oppose efforts to require Medicaid-type drug rebates from any Medicare Part D providers and all other kinds of mandated or negotiated Part D price controls that will harm beneficiaries and increase costs in other areas of Medicare. Support efforts to focus Medicare cost-saving efforts on eliminating improper payments, waste, fraud, and abuse first -- before cutting benefits, cutting payments to providers, or raising premium and coinsurance costs for beneficiaries. Support H.R. 3613 - Medicare Part D Beneficiary Appeals Fairness Act. Urged the "Super Committee" to resist proposals to erode beneficiary protections in Part D that ensure broad and accessible prescription drug formularies. Supported an extension of legislation to preserve access to osteoporosis testing for Medicare beneficiaries in the the final conference report on the Temporary Payroll Tax Cut Continuation Act of 2011 (H.R. 3630). Joined other patient advocate organizations to urge the National Government Services to to reconsider its policy regarding blanket denials under the Current Procedural Terminology (CPT) health and behavioral assessment and intervention codes (96150-96155) which restrict those medically appropriate services to Medicare beneficiaries with Alzheimer's disease. Support the MAPRx comments regarding the Draft 2013 Medicare Call Letter regarding proposed actions related to the Part D Prescription Drug Program. These included improved comments on beneficiary protections; Specialty Tiers; Co-pay Thresholds; Tier Labeling; Plan Rating Criteria; Medicare Therapy Management; and Drug Utilization Review Controls in Part D. Oppose Centers for Medicare and Medicaid Services (CMS) regulation that subjects dual-eligible Medicare/Medicaid beneficiaries to new state programs that may well diminish their Medicare protections and lessen their access to quality health care services. This includes passive enrollment into a managed care plan and disruptions to the continuity of care.

Client expense: $61,150 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

HR 3613, The Part D Beneficiary Appeals Fairness Act, Prevention and Public Health Fund, Affordable Care Act, HR 4209 The Patients' Access to Treatments Act

Client expense: $134,727 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), SENATE

Repeal Sustainable Growth Rate Formula; S. 1042 / H.R. 1700 Medicare Patient Empowerment Act; H.R. 3613 Part D Beneficiary Appeals Fairness Act; H.R. 3399 Medicare and Medicaid FAST Act; S. 1096 / H.R. 2020 Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act; Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111 - 148); Extension of Section 3111 of P.L. 111-148

Client expense: $100,000 · Firm income: Not reported

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

H.R. 891/S. 274: All provisions of the Medication Therapy Management Benefits Act of 2011; H.R. 905 /S. 733: All provisions of the legislation to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare; S. 31: All provisions of the Prescription Drug and Health Improvement Act of 2011; S. 44: All provisions of the Medicare Prescription Drug Price Negotiation Act of 2011; H.R. 999 / S. 560 - All provisions of the Medicare Prescription Drug Savings and Choice Act of 2011 Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, closing the Part D coverage gap Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, value-based insurance design, e-prescribing, PBM disclosure requirements, and medical loss ratio) Regulatory and proposed legislative changes to Medicare part D including EGWP waivers, MTM expansion, long term care short-term fills, recovery audit contractors Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs Regulatory Implementation of the HITECH Act FDA issues related to the Prescription Drug User Fee Act (PDUFA) (generic user fees, pedigree, REMs); implementation of approval pathway for generic biologic drugs 340b program H. R. 1290/S. 1206 - All provisions of The Medicare Prescription Savings Act Health care issues before the Joint Select Committee on Deficit Reduction H.R. 3613 the Part D Beneficiary Appeals Fairness Act S. 1356 / H.R. 3343 the Affordable Medicines Utilization Act H.R.4215 - All provisions of the Medicare Pharmacy Transparency and Fair Auditing Act

Client expense: $519,436 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), SENATE

Support American Society of Consultant Pharmacists and "Short Cycle Dispensing Coalition" recommendations regarding the delay and study of new long-term care pharmacy dispensing rules and the impact of those rules on Medicare and Medicaid patients. Support H.R. 1055, the Part D Off-Label Prescription Drug Parity Act. Continue to oppose cuts to Medicare benefits, and continue to oppose the Independent Payment Advisory Board (IPAB). Support Medicare Access for Patients Rx (MAPRx) recommendations to Centers for Medicare and Medicaid Services (CMS) all regarding Medicare Part D. Those MAPRx recommendations are in regard to: Improved beneficiary protections; Better, more transparent Specialty Tier guidance including the threshold for inclusion on this tier and the inclusion of data for newly approved drugs; New, more realistic co-pay thresholds; Automatic disenrollment from Special Needs Plans; Proposed plan rating criteria; and Approval of six-tier formularies. These are in addition to MAPRx concerns regarding: The Part D Medicare appeals process and the handling of enrollee complaints; Drug dispensing rules for Part D beneficiaries in long-term care facilities; the Authority to deny bids and potential additional restrictions; and Compound Drug Policy. Support repeal of IPAB (H.R. 452). Support changes to the Medicare Shared Savings Program: Accountable Care Organization (ACO) proposed regulations, to provide additional safeguards to guarantee patient access to needed care, and to ensure that ACO's support the adoption of new treatments and cures for patients. Also support the addition of new Alzheimer's disease focused ACO quality measures, new ACO measures of provider evidence of competency in Geriatrics and Dementia, as well as a guarantee that Alzheimer's and Dementia patients under ACO care will have access to the newest pharmaceutical and biological treatments. Support repeal of Section 6001 of the PPACA and remove all restrictions on physician-owned hospitals. (Support H.R. 1159 and H.R. 1186) Oppose federal budget cuts that would increase co-payments for home health care services under Medicare and/or Medicaid Support the Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011 (S. 1096 and H.R. 2020) Support MAPRx suggestions to CMS on Medicare Part D Prescription Drug Program regarding new beneficiary-friendly point-of-sale notices that address problems in filling prescriptions and clear, instructive remedies for beneficiaries. Oppose proposals that would reduce payments to providers of drugs and biologics under Medicare Part B. Oppose proposals to increase Medicare Part D cost-sharing, raise Part D coinsurance, and/or freeze income thresholds. Oppose efforts to require Medicaid-type drug rebates from any Medicare Part D providers and all other kinds of mandated or negotiated Part D price controls that will harm beneficiaries and increase costs in other areas of Medicare. Support efforts to focus Medicare cost-saving efforts on eliminating improper payments, waste, fraud, and abuse first -- before cutting benefits, cutting payments to providers, or raising premium and coinsurance costs for beneficiaries. Support H.R. 3613 - Medicare Part D Beneficiary Appeals Fairness Act. Urged the "Super Committee" to resist proposals to erode beneficiary protections in Part D that ensure broad and accessible prescription drug formularies. Supported an extension of legislation to preserve access to osteoporosis testing for Medicare beneficiaries in the the final conference report on the Temporary Payroll Tax Cut Continuation Act of 2011 (H.R. 3630). Joined other patient advocate organizations to urge the National Government Services to to reconsider its policy regarding blanket denials under the Current Procedural Terminology (CPT) health and behavioral assessment and intervention codes (96150-96155) which restrict those medically appropriate services to Medicare beneficiaries with Alzheimer's disease. Support the MAPRx comments regarding the Draft 2013 Medicare Call Letter regarding proposed actions related to the Part D Prescription Drug Program. These included improved comments on beneficiary protections; Specialty Tiers; Co-pay Thresholds; Tier Labeling; Plan Rating Criteria; Medicare Therapy Management; and Drug Utilization Review Controls in Part D.

Client expense: $83,191 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

HR 3613, The Part D Beneficiary Appeals Fairness Act, Prevention and Public Health Fund, Affordable Care Act HR 4209 Patient Access to Treatment Act

Client expense: $133,393 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE

Support American Society of Consultant Pharmacists and "Short Cycle Dispensing Coalition" recommendations regarding the delay and study of new long-term care pharmacy dispensing rules and the impact of those rules on Medicare and Medicaid patients. Support H.R. 1055, the Part D Off-Label Prescription Drug Parity Act. Continue to oppose cuts to Medicare benefits, and continue to oppose the Independent Payment Advisory Board (IPAB). Support Medicare Access for Patients Rx (MAPRx) recommendations to Centers for Medicare and Medicaid Services (CMS) all regarding Medicare Part D. Those MAPRx recommendations are in regard to: Improved beneficiary protections; Better, more transparent Specialty Tier guidance including the threshold for inclusion on this tier and the inclusion of data for newly approved drugs; New, more realistic co-pay thresholds; Automatic disenrollment from Special Needs Plans; Proposed plan rating criteria; and Approval of six-tier formularies. These are in addition to MAPRx concerns regarding: The Part D Medicare appeals process and the handling of enrollee complaints; Drug dispensing rules for Part D beneficiaries in long-term care facilities; the Authority to deny bids and potential additional restrictions; and Compound Drug Policy. Support repeal of IPAB (H.R. 452). Support changes to the Medicare Shared Savings Program: Accountable Care Organization (ACO) proposed regulations, to provide additional safeguards to guarantee patient access to needed care, and to ensure that ACO's support the adoption of new treatments and cures for patients. Also support the addition of new Alzheimer's disease focused ACO quality measures, new ACO measures of provider evidence of competency in Geriatrics and Dementia, as well as a guarantee that Alzheimer's and Dementia patients under ACO care will have access to the newest pharmaceutical and biological treatments. Support repeal of Section 6001 of the PPACA and remove all restrictions on physician-owned hospitals. (Support H.R. 1159 and H.R. 1186) Oppose federal budget cuts that would increase co-payments for home health care services under Medicare and/or Medicaid Support the Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011 (S. 1096 and H.R. 2020) Support MAPRx suggestions to CMS on Medicare Part D Prescription Drug Program regarding new beneficiary-friendly point-of-sale notices that address problems in filling prescriptions and clear, instructive remedies for beneficiaries. Oppose proposals that would reduce payments to providers of drugs and biologics under Medicare Part B. Oppose proposals to increase Medicare Part D cost-sharing, raise Part D coinsurance, and/or freeze income thresholds. Oppose efforts to require Medicaid-type drug rebates from any Medicare Part D providers and all other kinds of mandated or negotiated Part D price controls that will harm beneficiaries and increase costs in other areas of Medicare. Support efforts to focus Medicare cost-saving efforts on eliminating improper payments, waste, fraud, and abuse first -- before cutting benefits, cutting payments to providers, or raising premium and coinsurance costs for beneficiaries. Support H.R. 3613 - Medicare Part D Beneficiary Appeals Fairness Act. Urged the "Super Committee" to resist proposals to erode beneficiary protections in Part D that ensure broad and accessible prescription drug formularies. Supported an extension of legislation to preserve access to osteoporosis testing for Medicare beneficiaries in the final conference report on the Temporary Payroll Tax Cut Continuation Act of 2011 (H.R. 3630). Joined other patient advocate organizations to urge the National Government Services to reconsider its policy regarding blanket denials under the Current Procedural Terminology (CPT) health and behavioral assessment and intervention codes (96150-96155) which restrict those medically appropriate services to Medicare beneficiaries with Alzheimer's disease. Support the MAPRx comments regarding the Draft 2013 Medicare Call Letter regarding proposed actions related to the Part D Prescription Drug Program. These included improved comments on beneficiary protections; Specialty Tiers; Co-pay Thresholds; Tier Labeling; Plan Rating Criteria; Medicare Therapy Management; and Drug Utilization Review Controls in Part D.

Client expense: Not reported · Firm income: $12,238

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

HR 891 and S 274 - legislation that would expand the existing medication therapy management program in Medicare Part D S 31 and S 44 and HR 2248 and HR 3638 - legislation that would require or allow the federal government to negotiate prescription drug prices on behalf of Medicare Part D plan sponsors HR 999 and S 560 - legislation that would establish a nationwide Part D plan administered by the federal government HR 1055 - legislation that would allow Part D plan sponsors to offer "off-label" coverage of medications HR 2190 and S 1206 - legislation that would require prescription drug manufacturers to pay Medicaid "best price" rebates for covered prescription drugs purchased by dual eligibles under Medicare Part D HR 3613 - legislation that would require Medicare Part D plans to establish an exceptions process for patient cost-sharing amounts. HR 4215 - legislation that would establish audit requirements and other transparency requirements for Medicare Part D plan sponsors. Worked on proposed legislative language, work which included consultation with Senate committee staff, that would amend the current prompt payment rules in Medicare Part D in the interest of preventing fraud.

Client expense: $190,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General Medicare Protection, Prescription Drug Reimportation: H.R. 147 and S. 319; Medicare Prescription Drug Improvement: H.R. 3613; Waste and Fraud in Medicare: H.R. 3735

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support American Society of Consultant Pharmacists and "Short Cycle Dispensing Coalition" recommendations regarding the delay and study of new long-term care pharmacy dispensing rules and the impact of those rules on Medicare and Medicaid patients. Support H.R. 1055, the Part D Off-Label Prescription Drug Parity Act. Continue to oppose cuts to Medicare benefits, and continue to oppose the Independent Payment Advisory Board (IPAB). Support Medicare Access for Patients Rx (MAPRx) recommendations to Centers for Medicare and Medicaid Services (CMS) all regarding Medicare Part D. Those MAPRx recommendations are in regard to: Improved beneficiary protections; Better, more transparent Specialty Tier guidance including the threshold for inclusion on this tier and the inclusion of data for newly approved drugs; New, more realistic co-pay thresholds; Automatic disenrollment from Special Needs Plans; Proposed plan rating criteria; and Approval of six-tier formularies. These are in addition to MAPRx concerns regarding: The Part D Medicare appeals process and the handling of enrollee complaints; Drug dispensing rules for Part D beneficiaries in long-term care facilities; the Authority to deny bids and potential additional restrictions; and Compound Drug Policy. Support repeal of IPAB (H.R. 452). Support changes to the Medicare Shared Savings Program: Accountable Care Organization (ACO) proposed regulations, to provide additional safeguards to guarantee patient access to needed care, and to ensure that ACO's support the adoption of new treatments and cures for patients. Also support the addition of new Alzheimer's disease focused ACO quality measures, new ACO measures of provider evidence of competency in Geriatrics and Dementia, as well as a guarantee that Alzheimer's and Dementia patients under ACO care will have access to the newest pharmaceutical and biological treatments. Support repeal of Section 6001 of the PPACA and remove all restrictions on physician-owned hospitals. (Support H.R. 1159 and H.R. 1186) Oppose federal budget cuts that would increase co-payments for home health care services under Medicare and/or Medicaid Support the Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011 (S. 1096 and H.R. 2020) Support MAPRx suggestions to CMS on Medicare Part D Prescription Drug Program regarding new beneficiary-friendly point-of-sale notices that address problems in filling prescriptions and clear, instructive remedies for beneficiaries. Oppose proposals that would reduce payments to providers of drugs and biologics under Medicare Part B. Oppose proposals to increase Medicare Part D cost-sharing, raise Part D coinsurance, and/or freeze income thresholds. Oppose efforts to require Medicaid-type drug rebates from any Medicare Part D providers and all other kinds of mandated or negotiated Part D price controls that will harm beneficiaries and increase costs in other areas of Medicare. Support efforts to focus Medicare cost-saving efforts on eliminating improper payments, waste, fraud, and abuse first -- before cutting benefits, cutting payments to providers, or raising premium and coinsurance costs for beneficiaries. Support H.R. 3613 - Medicare Part D Beneficiary Appeals Fairness Act. Urged the "Super Committee" to resist proposals to erode beneficiary protections in Part D that ensure broad and accessible prescription drug formularies.

Client expense: Not reported · Firm income: $15,510

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Support American Society of Consultant Pharmacists and "Short Cycle Dispensing Coalition" recommendations regarding the delay and study of new long-term care pharmacy dispensing rules and the impact of those rules on Medicare and Medicaid patients. Support H.R. 1055, the Part D Off-Label Prescription Drug Parity Act. Continue to oppose cuts to Medicare benefits, and continue to oppose the Independent Payment Advisory Board (IPAB). Support Medicare Access for Patients Rx (MAPRx) recommendations to Centers for Medicare and Medicaid Services (CMS) all regarding Medicare Part D. Those MAPRx recommendations are in regard to: Improved beneficiary protections; Better, more transparent Specialty Tier guidance including the threshold for inclusion on this tier and the inclusion of data for newly approved drugs; New, more realistic co-pay thresholds; Automatic disenrollment from Special Needs Plans; Proposed plan rating criteria; and Approval of six-tier formularies. These are in addition to MAPRx concerns regarding: The Part D Medicare appeals process and the handling of enrollee complaints; Drug dispensing rules for Part D beneficiaries in long-term care facilities; the Authority to deny bids and potential additional restrictions; and Compound Drug Policy. Support repeal of IPAB (H.R. 452). Support changes to the Medicare Shared Savings Program: Accountable Care Organization (ACO) proposed regulations, to provide additional safeguards to guarantee patient access to needed care, and to ensure that ACO's support the adoption of new treatments and cures for patients. Also support the addition of new Alzheimer's disease focused ACO quality measures, new ACO measures of provider evidence of competency in Geriatrics and Dementia, as well as a guarantee that Alzheimer's and Dementia patients under ACO care will have access to the newest pharmaceutical and biological treatments. Support repeal of Section 6001 of the PPACA and remove all restrictions on physician-owned hospitals. (Support H.R. 1159 and H.R. 1186) Oppose federal budget cuts that would increase co-payments for home health care services under Medicare and/or Medicaid Support the Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011 (S. 1096 and H.R. 2020) Support MAPRx suggestions to CMS on Medicare Part D Prescription Drug Program regarding new beneficiary-friendly point-of-sale notices that address problems in filling prescriptions and clear, instructive remedies for beneficiaries. Oppose proposals that would reduce payments to providers of drugs and biologics under Medicare Part B. Oppose proposals to increase Medicare Part D cost-sharing, raise Part D coinsurance, and/or freeze income thresholds. Oppose efforts to require Medicaid-type drug rebates from any Medicare Part D providers and all other kinds of mandated or negotiated Part D price controls that will harm beneficiaries and increase costs in other areas of Medicare. Support efforts to focus Medicare cost-saving efforts on eliminating improper payments, waste, fraud, and abuse first -- before cutting benefits, cutting payments to providers, or raising premium and coinsurance costs for beneficiaries. Support H.R. 3613 - Medicare Part D Beneficiary Appeals Fairness Act. Urged the "Super Committee" to resist proposals to erode beneficiary protections in Part D that ensure broad and accessible prescription drug formularies.

Client expense: $37,740 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Discussed the CHAMPVA Children's Protection Act of 2011 (HR 115/S.490). This legislation increases from 23 to 26 the maximum age of eligibility for certain dependent children of veterans for medical care under CHAMPVA (the Civilian Health and Medical Program of the Department of Veterans Affairs (VA). Urged Congress to leave any needed Social Security reforms out of the deliberations of the Joint Select Committee on Deficit Reduction. Includes the submission of a letter and report to Congress and the Administration detailing the detrimental impact that adopting the chained CPI would have on veterans. Endorsed the importance of Social Security for veterans and their families through the booklet, "Social Secruity: Serving Those Who Serve Our Nation." Helped draft and endorse a letter to the Social Security Administration in opposition to interim final rules that would ban claimants from SSA offices for as much as three years for displaying disruptive behavior. Supported co-sponsorship of H.R. 3613 - Part D Beneficiary Appeals Fairness Act. This legislation allows beneficiaries an exceptions process that would allow specialty drugs to be moved to lower, more affordable and accessible categories for beneficiaries with high cost chronic conditions and disabilities. United Spinal signed onto a letter encouraging cosponsorship of H.R. 3613. Opposed H.R. 1173, Fiscal Responsibility and Retirement Security Act of 2011. This legislation repeals the Community Living Assistance Services and Supports (CLASS) program. Endorsed comments in response to proposed rule for Changes to the Medicare Prescription Drug Program (Part D) for Contract Year 2013. Comments expressed support for the rule's efforts to improve Part D beneficairy protections and remove poorly performing plans. Areas addressed in the rule are: coverage gap provisions, beneficiary protections, excluding poor performers, program efficiencies and program requirements. Participated in the development of Consortium for Citizens with Disabilities Principles for reforms in the Social Security disability benefit programs, including Supplemental Security Income (SSI) and disability coverage in the Old Age, Survivors and Disability Insurance (SSDI). Submitted principles to House Ways and Means Social Security Subcommittee hearing on the social security disability programs.

Client expense: $70,000 · Firm income: Not reported

Government targets: AMTRAK - Natl Railroad Passenger Corporation, Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, Social Security Administration (SSA), Veterans Affairs, Dept of (VA), White House Office

Implementation of Pub. Law No. 111-148, the Patient Protection and Affordable Care Act, primarily patient protection provisions, provisions on breast health education and postal provision. (Continued on Addendum) H.R.3070/S.1599, Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations Act, 2012, primarily matters related to appropriations for cancer research and cancer screening programs. H.R.2219, Department of Defense Appropriations Act, 2012, primarily matters related to appropriations for Congressional Directed Medical Research Programs. Pub. Law No. 112-25, the Budget Control Act of 2011, primarily matters related to funding of cancer research and breast cancer programs. H.R.466/S. 384, Breast Cancer Research Stamp Reauthorization Act. H.R.2245/S.296, Preserving Access to Life-Saving Medications Act of 2011, primarily matters related to cancer treatments. H.R.2499, Lymphedema Diagnosis and Treatment Cost-Saving Act of 2011. H.R.3613, Part D Beneficiary Appeals Fairness Act, primarily matters related to specialty tiers of prescription drugs. H.R.3102, Breast Density and Mammography Reporting Act of 2011. H.R.3067, Accelerating the End of Breast Cancer Act of 2011. H.R.3705, Comprehensive Cancer Care Improvement Act of 2011. H.R.2746, Cancer Drug Coverage Parity Act of 2011. H.R.111, Breast Cancer Patient Protection Act of 2011.

Client expense: $160,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

H.R. 891/S. 274: All provisions of the Medication Therapy Management Benefits Act of 2011; H.R. 905 /S. 733: All provisions of the legislation to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare; S. 31: All provisions of the Prescription Drug and Health Improvement Act of 2011; S. 44: All provisions of the Medicare Prescription Drug Price Negotiation Act of 2011; H.R. 999 / S. 560 All provisions of the Medicare Prescription Drug Savings and Choice Act of 2011 Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, closing the Part D coverage gap Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, value-based insurance design, e-prescribing, PBM disclosure requirements, and medical loss ratio) Regulatory and proposed legislative changes to Medicare part D including EGWP waivers, MTM expansion, long term care short-term fills, recovery audit contractors Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs Regulatory Implementation of the HITECH Act FDA issues related to the Prescription Drug User Fee Act (PDUFA) (generic user fees, pedigree, REMs); implementation of approval pathway for generic biologic drugs 340b program All provisions of H. R. 1290/S. 1206 - The Medicare Prescription Savings Act Health care issues before the Joint Select Committee on Deficit Reduction H.R. 3613 the Part D Beneficiary Appeals Fairness Act S. 1356 / H.R. 3343 the Affordable Medicines Utilization Act

Client expense: $446,695 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), SENATE

HR 3613, The Part D Beneficiary Appeals Fairness Act, Prevention and Public Health Fund, Affordable Care Act

Client expense: $133,393 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE

General Medicare Protection, Prescription Drug Reimportation: H.R. 147 and S. 319, Medicare Prescription Drug Improvement: H.R. 3613

Client expense: $40,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General Medicare Protection, Prescription Drug Reimportation: H.R. 147 and S. 319; Medicare Prescription Improvement: H.R. 3613

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE