Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011

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

-- H.R. 2020 / S. 1096 - Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011: Legislation to set payment rates for physicians for dual-energy x-ray absorptiometry (DXA) screening tests at 70 percent of the 2006 rate for 2012 and 2013. -- H.R. 8 - American Taxpayer Relief Act of 2012: Medicare phyisican payment for 2013.

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Coverage and Reimbursement issues; Implementation of P.L. 111-148 - Patient Protection and Affordable Care Act (DXA test); and P.L. 111-152 - Health Care and Education Reconciliation Act (DXA testing); Medicare access to DXA services including S. 1096 & HR 2020 - Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011.

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Coverage and Reimbursement issues; Implementation of P.L. 111-148 - Patient Protection and Affordable Care Act (DXA testing); and P.L. 111-152- Health Care and Education Reconciliation Act (DXA testing); Medicare access to DXA services including S. 1096 & HR 2020 - Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011.

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Coverage and Reimbursement issues; Implementation of P.L. 111-148 - Patient Protection and Affordable Care Act (DXA testing); and P.L. 111-152- Health Care and Education Reconciliation Act (DXA testing); Medicare access to DXA services including S. 1096 & HR 2020 - Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011; and Medicare Part B reimbursement for prescription drugs.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 17 - Medical Device Access and Innovation Protection Act of 2011 HR 436 - Protect Medical Innovation Act of 2011 HR 2020 and S 1096 - Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011 Medicare Reimbursement for Imaging Services HR 3269 - Diagnostic Imaging Services Access Protection Act of 2011 Helium Shortage S 2374 - Helium Stewardship Act of 2012 HR 6014 Katie Sepich Enhanced DNA Collection Act of 2012 HR 8 American Taxpayer Relief Act of 2012

Client expense: $4,940,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Fiscal Year 2012 Appropriations for National Institutes of Health Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011 (H.R. 2020/S. 1096) Endocrine Disruptor Screening Enhancement Act of 2011 (HR 533) Endocrine-Disrupting Chemicals Exposure Elimination Act of 2011 (HR 2521/S.1361) Medicare Physician Payment Reform Funding for the National Diabetes Prevention Program (NDPP)

Client expense: Not reported · Firm income: $20,000

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

Sustainable Growth Rate Formula Reform (general); H.R. 452, Medicare Decisions Accountability Act; S. 688, Health Care Bureaucrats Elimination Act; Imaging (general); Medicaid (general); H.R. 2020/ S.1096, Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act; Strong Start Initiative; Primary care payment bonuses; H.R. 5707, Medicare Physician Payment Innovation Act of 2012. H.R. 6352, Resident Physician Shortage Reduction and Graduate Medical Education Accountability and Transparency Act; H.R. 3667, Primary Care Workforce Access Improvement Act of 2011; H.R. 3269/S. 2347, Diagnostic Imaging Services Access Protection Act of 2011.

Client expense: $245,727 · 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), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, White House Office

Support the speedy implementation of the National Alzheimer's Project Act (NAPA) by HHS, and support Leaders Engaged on Alzheimer's Disease (LEAD) recommendations as to how to proceed. Support repeal of Section 6001 of the PPACA and remove all restrictions on physician-owned hospitals. (Support H.R. 1159 and H.R. 1186) Support extensive clinical trials, manufacturing inspections and post-market surveillance for all biosimilar drugs. Support higher PDUFA fees for biosimilar drugs to pay for the additional safeguards needed. Oppose federal budget cuts that would increase co-payments for home health care services under Medicare and/or Medicaid. Support all legislative and regulatory action to modernize the FDA and to speed new cures and therapies to patients. Support the Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011 (S. 1096, H.R. 2020) Support Leaders Engaged on Alzheimer's Disease (LEAD) FY 2012 funding proposals in the amount of for $35 billion for the National Institutes of Health (NIH), $1.4 billion for the National Institute on Aging (NIA), $100 million for the Cures Acceleration Network (CAN), $11.46 million for the Alzheimer's Disease Supportive Services Program (ADSSP), $192 million for the National Family Caregiver Support Program (NFCSP), $50 million for the Lifespan Respite Care Program (LRCP), and$2.744 billion for the Food and Drug Administration (FDA), as well as $2 million for the Missing Alzheimer's Disease Patient Alert Program and $750,000 to organize and host a high-level meeting to focus on the global Alzheimer's disease crisis. Oppose proposals that would reduce Medicare payments for providers of drugs and biologics under Medicare Part B. Support the proposed Prescription Drug User Fee Act Reauthorization Agreement (PDUFA-V) now under consideration by the Congress for reauthorization. Support an extension of the Therapeutic Discovery Project Tax Credit (I.R.C. 48D). Oppose the proposed merger between pharmacy benefit managers (PBM) Medco Health Solutions (Medco) and Express Scripts, Inc. (ESI), including comments to the Federal Trade Commission on the merger's obvious danger to older Americans. Support the development of clearly-defined, comprehensive, patient-centric Essential Health Benefits rules under the Affordable Care Act. Support the Counterfeit Drug Penalty Enhancement Act of 2011. 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. Joined other patient advocate organizations January 2012 to urge HHS to ensure that ACA "Essential Health Benefits" guidelines provide comprehensive, quality and affordable health care. This was in response to the HHS December 16, 2011 bulletin on Essential Health Benefits because the HHS bulletin did not provide adequate patient protections as intended under the ACA. Joined other patient advocate groups to support the Spending Reductions through Innovations in Therapies (SPRINT) Act (H.R. 3891 and S. 2064) Support H.R.5998, the USPSTF Transparency and Accountability Act of 2012. Support the creation of the National Center for AdvancingTranslations Sciences' (NCATS) "Discovering New Therapeutic Uses for Existing Molecules Initiative." Support the new Centers for Disease Control recommendations regarding the identification of chronic Hepatitis C infections. Urge all providers and payers to follow those same CDC recommendations. Oppose the substitution and use of unapproved and off-label drugs to treat age-related macular degeneration (AMD). Urge the Department of HHS to adopt the Advisory Council on Alzheimer's Research recommendations and ensure that the final National Alzheimer's Plan includes measures: Providing high-level, overall accountability for National Plan implementation. Recognizing and proposing a path forward to secure the public and private resources needed to achieve all of the goals. Forming robust public-private partnerships between government and industry to inform the research agenda, shorten the time and cost of developing therapies, and accelerate delivery of safe and effective treatments to individuals with Alzheimers. Fostering greater collaboration on research and other issues with international counterparts to achieve global coordination and progress toward a Global Alzheimers Action Plan. Expanding attention on early detection and diagnosis of Alzheimers disease. Ensuring access to the full array of long-term support services for special and emerging populations of people with Alzheimers disease, including younger people and those with developmental disabilities. Addressing caregivers physical and behavioral health. Expanding access to high quality, cost-effective and evidence based care and redoubling efforts to test and validate innovative care interventions. Support extensive clinical trials, manufacturing inspections and post-market surveillance for all biosimilar drugs. Support higher PDUFA fees for biosimilar drugs to pay for the additional safeguards needed. Support stiff restrictions on biosimilar "flexibility" (intentionally introducing differences to the molecule or the finished product) that adds high risk. Support distinctive labeling for safety, and install a strong track and trace system before the first biosimilar is allowed on the market. Support Congressional review and oversight to examine the National Alzheimer's Plan implementation progress. 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

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

S. 1096- The Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act and related Medicare issues H.R. 8- American Taxpayer Relief Act of 2012 - focused on provisions related to imaging and devices. PL 112-25- Budget Control Act of 2011. Monitoring Medicare proposals impacting imaging, screening, and health information technology.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support the speedy implementation of the National Alzheimer's Project Act (NAPA) by HHS, and support Leaders Engaged on Alzheimer's Disease (LEAD) recommendations as to how to proceed. Support repeal of Section 6001 of the PPACA and remove all restrictions on physician-owned hospitals. (Support H.R. 1159 and H.R. 1186) Support extensive clinical trials, manufacturing inspections and post-market surveillance for all biosimilar drugs. Support higher PDUFA fees for biosimilar drugs to pay for the additional safeguards needed. Oppose federal budget cuts that would increase co-payments for home health care services under Medicare and/or Medicaid. Support all legislative and regulatory action to modernize the FDA and to speed new cures and therapies to patients. Support the Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011 (S. 1096, H.R. 2020) Support Leaders Engaged on Alzheimer's Disease (LEAD) FY 2012 funding proposals in the amount of for $35 billion for the National Institutes of Health (NIH), $1.4 billion for the National Institute on Aging (NIA), $100 million for the Cures Acceleration Network (CAN), $11.46 million for the Alzheimer's Disease Supportive Services Program (ADSSP), $192 million for the National Family Caregiver Support Program (NFCSP), $50 million for the Lifespan Respite Care Program (LRCP), and$2.744 billion for the Food and Drug Administration (FDA), as well as $2 million for the Missing Alzheimer's Disease Patient Alert Program and $750,000 to organize and host a high-level meeting to focus on the global Alzheimer's disease crisis. Oppose proposals that would reduce Medicare payments for providers of drugs and biologics under Medicare Part B. Support the proposed Prescription Drug User Fee Act Reauthorization Agreement (PDUFA-V) now under consideration by the Congress for reauthorization. Support an extension of the Therapeutic Discovery Project Tax Credit (I.R.C. 48D). Oppose the proposed merger between pharmacy benefit managers (PBM) Medco Health Solutions (Medco) and Express Scripts, Inc. (ESI), including comments to the Federal Trade Commission on the merger's obvious danger to older Americans. Support the development of clearly-defined, comprehensive, patient-centric Essential Health Benefits rules under the Affordable Care Act. Support the Counterfeit Drug Penalty Enhancement Act of 2011. 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. Joined other patient advocate organizations January 2012 to urge HHS to ensure that ACA "Essential Health Benefits" guidelines provide comprehensive, quality and affordable health care. This was in response to the HHS December 16, 2011 bulletin on Essential Health Benefits because the HHS bulletin did not provide adequate patient protections as intended under the ACA. Joined other patient advocate groups to support the Spending Reductions through Innovations in Therapies (SPRINT) Act (H.R. 3891 and S. 2064) Support H.R.5998, the USPSTF Transparency and Accountability Act of 2012. Support the creation of the National Center for AdvancingTranslations Sciences' (NCATS) "Discovering New Therapeutic Uses for Existing Molecules Initiative." Support the new Centers for Disease Control recommendations regarding the identification of chronic Hepatitis C infections. Urge all providers and payers to follow those same CDC recommendations. Oppose the substitution and use of unapproved and off-label drugs to treat age-related macular degeneration (AMD). Urge the Department of HHS to adopt the Advisory Council on Alzheimer's Research recommendations and ensure that the final National Alzheimer's Plan includes measures: Providing high-level, overall accountability for National Plan implementation. Recognizing and proposing a path forward to secure the public and private resources needed to achieve all of the goals. Forming robust public-private partnerships between government and industry to inform the research agenda, shorten the time and cost of developing therapies, and accelerate delivery of safe and effective treatments to individuals with Alzheimers. Fostering greater collaboration on research and other issues with international counterparts to achieve global coordination and progress toward a Global Alzheimers Action Plan. Expanding attention on early detection and diagnosis of Alzheimers disease. Ensuring access to the full array of long-term support services for special and emerging populations of people with Alzheimers disease, including younger people and those with developmental disabilities. Addressing caregivers physical and behavioral health. Expanding access to high quality, cost-effective and evidence based care and redoubling efforts to test and validate innovative care interventions. Support extensive clinical trials, manufacturing inspections and post-market surveillance for all biosimilar drugs. Support higher PDUFA fees for biosimilar drugs to pay for the additional safeguards needed. Support stiff restrictions on biosimilar "flexibility" (intentionally introducing differences to the molecule or the finished product) that adds high risk. Support distinctive labeling for safety, and install a strong track and trace system before the first biosimilar is allowed on the market. Support Congressional review and oversight to examine the National Alzheimer's Plan implementation progress.

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

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

-- H.R. 2020 / S. 1096 - Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011: Legislation to set payment rates for physicians for dual-energy x-ray absorptiometry (DXA) screening tests at 70 percent of the 2006 rate for 2012 and 2013. -- Medicare phyisican payment for 2013.

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Coverage and Reimbursement issues; Implementation of P.L. 111-148 - Patient Protection and Affordable Care Act (DXA test); and P.L. 111-152 - Health Care and Education Reconciliation Act (DXA testing); Medicare access to DXA services including S. 1096 & HR 2020 - Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011.

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, 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

Medicare Coverage and Reimbursement issues; Implementation of P.L. 111-148 - Patient Protection and Affordable Care Act (DXA testing); and P.L. 111-152- Health Care and Education Reconciliation Act (DXA testing); Medicare access to DXA services including S. 1096 & HR 2020 - Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011.

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 17 - Medical Device Access and Innovation Protection Act of 2011 HR 436 - Protect Medical Innovation Act of 2011 S 223 - FAA Air Transportation Modernization and Safety Improvement Act HR 658 - FAA Reauthorization and Reform Act of 2011 HR 2461 - Physician Pathology Services Continuity Act of 2011 HR 2020 and S 1096 - Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011 HR 2832 - To extend the Generalized System of Preferences, and for other purposes FDA 510(k) Reform Health Information Technology Medicare Reimbursement for Imaging Services Medicare Reimbursement for Radiopharmaceuticals Medicare Coverage of New Technologies United States Preventive Services Task Force Issues Patient Safety Organizations Laboratory Developed Tests Physician Payments Sunshine HR 3630 - Middle Class Tax Relief and Job Creation Act of 2012 HR 3207 - Modernizing Laboratory Test Standards for Patients Act of 2011 HR 3269 - Diagnostic Imaging Services Access Protection Act of 2011 Helium Shortage S 1995 - Medical Device Patient Safety Act HR 2104 - Consistency, Accuracy, Responsibility and Excellence in Medical Imaging and Radiation Therapy Act of 2011 S 3338 - Consistency, Accuracy, Responsibility and Excellence in Medical Imaging and Radiation Therapy Act of 2011 S 2374 - Helium Stewardship Act of 2012 S3187 - Food and Drug Administration Safety and Innovation Act

Client expense: $3,890,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Export-Import Bank of the United States (EXIM Bank), Federal Aviation Administration (FAA), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

S 17 - Medical Device Access and Innovation Protection Act of 2011 HR 436 - Protect Medical Innovation Act of 2011 S 223 - FAA Air Transportation Modernization and Safety Improvement Act HR 658 - FAA Reauthorization and Reform Act of 2011 HR 2461 - Physician Pathology Services Continuity Act of 2011 HR 2020 and S 1096 - Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011 HR 2832 - To extend the Generalized System of Preferences, and for other purposes FDA 510(k) Reform Health Information Technology Medicare Reimbursement for Imaging Services Medicare Reimbursement for Radiopharmaceuticals Medicare Coverage of New Technologies United States Preventive Services Task Force Issues Patient Safety Organizations Laboratory Developed Tests Physician Payments Sunshine HR 3630 - Middle Class Tax Relief and Job Creation Act of 2012 HR 3207 - Modernizing Laboratory Test Standards for Patients Act of 2011 HR 3269 - Diagnostic Imaging Services Access Protection Act of 2011 Helium Shortage S 1995 - Medical Device Patient Safety Act

Client expense: $5,280,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Export-Import Bank of the United States (EXIM Bank), Federal Aviation Administration (FAA), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Medicare Coverage and Reimbursement issues; Implementation of P.L. 111-148 - Patient Protection and Affordable Care Act (DXA testing); and P.L. 111-152- Health Care and Education Reconciliation Act (DXA testing); Medicare access to DXA services including S. 1096 & HR 2020 - Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011; and Medicare Part B reimbursement for prescription drugs.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Fiscal Year 2012 Appropriations for National Institutes of Health Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011 (H.R. 2020/S. 1096) Endocrine Disrupter Screening Enhancement Act of 2011 (HR 533) Endocrine-Disrupting Chemicals Exposure Elimination Act of 2011 (HR 2521/S.1361) Medicare Physician Payment Reform Funding for the National Diabetes Prevention Program (NDPP)

Client expense: Not reported · Firm income: $20,000

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

Sustainable Growth Rate Formula Reform (general); H.R. 452, Medicare Decisions Accountability Act; S. 688, Health Care Bureaucrats Elimination Act; Imaging (general); Medicaid (general); H.R. 2020/ S.1096, Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act; Strong Start Initiative; Primary care payment bonuses; H.R. 5707, Medicare Physician Payment Innovation Act of 2012. H.R. 6352, Resident Physician Shortage Reduction and Graduate Medical Education Accountability and Transparency Act; H.R. 3667, Primary Care Workforce Access Improvement Act of 2011; H.R. 3269/S. 2347, Diagnostic Imaging Services Access Protection Act of 2011.

Client expense: $312,442 · 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), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, White House Office

Support the speedy implementation of the National Alzheimer's Project Act (NAPA) by HHS, and support Leaders Engaged on Alzheimer's Disease (LEAD) recommendations as to how to proceed. Support repeal of Section 6001 of the PPACA and remove all restrictions on physician-owned hospitals. (Support H.R. 1159 and H.R. 1186) Support extensive clinical trials, manufacturing inspections and post-market surveillance for all biosimilar drugs. Support higher PDUFA fees for biosimilar drugs to pay for the additional safeguards needed. Oppose federal budget cuts that would increase co-payments for home health care services under Medicare and/or Medicaid. Support all legislative and regulatory action to modernize the FDA and to speed new cures and therapies to patients. Support the Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011 (S. 1096, H.R. 2020) Support Leaders Engaged on Alzheimer's Disease (LEAD) FY 2012 funding proposals in the amount of for $35 billion for the National Institutes of Health (NIH), $1.4 billion for the National Institute on Aging (NIA), $100 million for the Cures Acceleration Network (CAN), $11.46 million for the Alzheimer's Disease Supportive Services Program (ADSSP), $192 million for the National Family Caregiver Support Program (NFCSP), $50 million for the Lifespan Respite Care Program (LRCP), and$2.744 billion for the Food and Drug Administration (FDA), as well as $2 million for the Missing Alzheimer's Disease Patient Alert Program and $750,000 to organize and host a high-level meeting to focus on the global Alzheimer's disease crisis. Oppose proposals that would reduce Medicare payments for providers of drugs and biologics under Medicare Part B. Support the proposed Prescription Drug User Fee Act Reauthorization Agreement (PDUFA-V) now under consideration by the Congress for reauthorization. Support an extension of the Therapeutic Discovery Project Tax Credit (I.R.C. 48D). Oppose the proposed merger between pharmacy benefit managers (PBM) Medco Health Solutions (Medco) and Express Scripts, Inc. (ESI), including comments to the Federal Trade Commission on the merger's obvious danger to older Americans. Support the development of clearly-defined, comprehensive, patient-centric Essential Health Benefits rules under the Affordable Care Act. Support the Counterfeit Drug Penalty Enhancement Act of 2011. 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. Joined other patient advocate organizations January 2012 to urge HHS to ensure that ACA "Essential Health Benefits" guidelines provide comprehensive, quality and affordable health care. This was in response to the HHS December 16, 2011 bulletin on Essential Health Benefits because the HHS bulletin did not provide adequate patient protections as intended under the ACA. Joined other patient advocate groups to support the Spending Reductions through Innovations in Therapies (SPRINT) Act (H.R. 3891 and S. 2064) Support H.R.5998, the USPSTF Transparency and Accountability Act of 2012. Support the creation of the National Center for AdvancingTranslations Sciences' (NCATS) "Discovering New Therapeutic Uses for Existing Molecules Initiative." Support the new Centers for Disease Control recommendations regarding the identification of chronic Hepatitis C infections. Urge all providers and payers to follow those same CDC recommendations. Oppose the substitution and use of unapproved and off-label drugs to treat age-related macular degeneration (AMD). Urge the Department of HHS to adopt the Advisory Council on Alzheimer's Research recommendations and ensure that the final National Alzheimer's Plan includes measures: Providing high-level, overall accountability for National Plan implementation. Recognizing and proposing a path forward to secure the public and private resources needed to achieve all of the goals. Forming robust public-private partnerships between government and industry to inform the research agenda, shorten the time and cost of developing therapies, and accelerate delivery of safe and effective treatments to individuals with Alzheimers. Fostering greater collaboration on research and other issues with international counterparts to achieve global coordination and progress toward a Global Alzheimers Action Plan. Expanding attention on early detection and diagnosis of Alzheimers disease. Ensuring access to the full array of long-term support services for special and emerging populations of people with Alzheimers disease, including younger people and those with developmental disabilities. Addressing caregivers physical and behavioral health. Expanding access to high quality, cost-effective and evidence based care and redoubling efforts to test and validate innovative care interventions. Support extensive clinical trials, manufacturing inspections and post-market surveillance for all biosimilar drugs. Support higher PDUFA fees for biosimilar drugs to pay for the additional safeguards needed. Support stiff restrictions on biosimilar "flexibility" (intentionally introducing differences to the molecule or the finished product) that adds high risk. Support distinctive labeling for safety, and install a strong track and trace system before the first biosimilar is allowed on the market. Support Congressional review and oversight to examine the National Alzheimer's Plan implementation progress.

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

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

S. 1096- The Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act and related Medicare issues

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

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

Medicare Coverage and Reimbursement issues; Implementation of P.L. 111-148 - Patient Protection and Affordable Care Act (DXA testing); and P.L. 111-152- Health Care and Education Reconciliation Act (DXA testing); Medicare access to DXA services including S. 1096 & HR 2020 - Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011; and related provisions in the Temporary Payroll Tax Cut Continuation Act of 2011 (HR 3743, HR 3765 and HR 3630).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Coverage and Reimbursement issues; Implementation of P.L. 111-148 - Patient Protection and Affordable Care Act (DXA testing); and P.L. 111-152- Health Care and Education Reconciliation Act (DXA testing); Medicare access to DXA services including S. 1096 & HR 2020 - Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011; and related provisions in the Temporary Payroll Tax Cut Continuation Act of 2011 (HR 3743, HR 3765 and HR 3630).

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare access to DXA services including S. 1096 & HR 2020 - Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011; Implementation of P.L. 111-148 - Patient Protection and Affordable Care Act (DXA testing); and P.L. 111-152- Health Care and Education Reconciliation Act (DXA testing); and related provisions in the Temporary Payroll Tax Cut Continuation Act of 2011 (HR 3743, HR 3765 and HR 3630).

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Coverage and Reimbursement issues; Implementation of P.L. 111-148 - Patient Protection and Affordable Care Act (DXA test); and P.L. 111-152 - Health Care and Education Reconciliation Act (DXA testing); Medicare access to DXA services including S. 1096 & HR 2020 - Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011; and related provisions in the Temporary Payroll Tax Cut Continuation Act of 2011 (HR 3743, HR 3765 and HR 3630).

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Coverage and Reimbursement issues; Implementation of P.L. 111-148 - Patient Protection and Affordable Care Act (DXA test); and P.L. 111-152 - Health Care and Education Reconciliation Act (DXA testing); Medicare access to DXA services including S. 1096 & HR 2020 - Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011; and related provisions in the Temporary Payroll Tax Cut Continuation Act of 2011 (HR 3743, HR 3765 and HR 3630).

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2020/S. 1096 Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011 Fiscal Year 2012 Appropriations for National Institutes of Health H.R. 533 Endocrine Disruptor Screening Enhancement Act of 2011 H.R. 2521/S. 1361 Endocrine Disrupting Chemicals Exposure Elimination Act of 2011 Medicare Physician Payment Reform Funding for National Diabetes Prevention Program (NDPP)

Client expense: Not reported · Firm income: $20,000

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

S 17 - Medical Device Access and Innovation Protection Act of 2011 HR 436 - Protect Medical Innovation Act of 2011 S 223 - FAA Air Transportation Modernization and Safety Improvement Act HR 658 - FAA Reauthorization and Reform Act of 2011 HR 2461 - Physician Pathology Services Continuity Act of 2011 HR 2020 and S 1096 - Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011 HR 2832 - To extend the Generalized System of Preferences, and for other purposes FDA 510(k) Reform Health Information Technology Medicare Reimbursement for Imaging Services Medicare Reimbursement for Radiopharmaceuticals Medicare Coverage of New Technologies United States Preventive Services Task Force Issues Patient Safety Organizations Laboratory Developed Tests Physician Payments Sunshine HR 3630 - Middle Class Tax Relief and Job Creation Act of 2012 HR 3207 - Modernizing Laboratory Test Standards for Patients Act of 2011 HR 3269 - Diagnostic Imaging Services Access Protection Act of 2011 Helium Shortage S 1995 - Medical Device Patient Safety Act HR 2104 - Consistency, Accuracy, Responsibility and Excellence in Medical Imaging and Radiation Therapy Act of 2011 S 3338 - Consistency, Accuracy, Responsibility and Excellence in Medical Imaging and Radiation Therapy Act of 2011 S 2374 - Helium Stewardship Act of 2012 S3187 - Food and Drug Administration Safety and Innovation Act

Client expense: $4,860,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Export-Import Bank of the United States (EXIM Bank), Federal Aviation Administration (FAA), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Medicare Part B reimbursement and coverage of dialysis products Medicare Part B Reimbursement Issues Medicare Part D Issues S. 1096, Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act

Client expense: $1,980,000 · Firm income: Not reported

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

Medicare Part B reimbursement and coverage of dialysis products Medicare Part B Reimbursement Issues Medicare Part D Issues S. 1096, Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act

Client expense: $1,980,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

-- H.R. 2020 / S. 1096 - Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011: Legislation to set payment rates for physicians for dual-energy x-ray absorptiometry (DXA) screening tests at 70 percent of the 2006 rate for 2012 and 2013. -- Medicare phyisican payment for 2013.

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Sustainable Growth Rate Formula Reform (general); H.R. 452, Medicare Decisions Accountability Act; S. 688, Health Care Bureaucrats Elimination Act; Imaging (general); Medicaid (general); H.R. 2020/ S.1096, Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act; Strong Start Initiative; Primary care payment bonuses.

Client expense: $316,855 · 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), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, White House Office

General health care coverage and issues pertaining to medicare reimbursement. S. 1096

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Sustainable growth rate and impact on Medicare programs, Medicare physician payment, budget offsets - HR 3630, Temporary Payroll Tax Cut Continuation Act of 2011. Osteoporosis testing for Medicare beneficiaries - HR 2020, Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011; S 1096, Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011.

Client expense: Not reported · Firm income: $62,500

Government targets: HOUSE OF REPRESENTATIVES

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 the speedy implementation of the National Alzheimer's Project Act (NAPA) by HHS, and support Leaders Engaged on Alzheimer's Disease (LEAD) recommendations as to how to proceed. Support repeal of Section 6001 of the PPACA and remove all restrictions on physician-owned hospitals. (Support H.R. 1159 and H.R. 1186) Support extensive clinical trials, manufacturing inspections and post-market surveillance for all biosimilar drugs. Support higher PDUFA fees for biosimilar drugs to pay for the additional safeguards needed. Oppose federal budget cuts that would increase co-payments for home health care services under Medicare and/or Medicaid. Support all legislative and regulatory action to modernize the FDA and to speed new cures and therapies to patients. Support the Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011 (S. 1096, H.R. 2020) Support Leaders Engaged on Alzheimer's Disease (LEAD) FY 2012 funding proposals in the amount of for $35 billion for the National Institutes of Health (NIH), $1.4 billion for the National Institute on Aging (NIA), $100 million for the Cures Acceleration Network (CAN), $11.46 million for the Alzheimer's Disease Supportive Services Program (ADSSP), $192 million for the National Family Caregiver Support Program (NFCSP), $50 million for the Lifespan Respite Care Program (LRCP), and$2.744 billion for the Food and Drug Administration (FDA), as well as $2 million for the Missing Alzheimer's Disease Patient Alert Program and $750,000 to organize and host a high-level meeting to focus on the global Alzheimer's disease crisis. Oppose proposals that would reduce Medicare payments for providers of drugs and biologics under Medicare Part B. Support the proposed Prescription Drug User Fee Act Reauthorization Agreement (PDUFA-V) now under consideration by the Congress for reauthorization. Support an extension of the Therapeutic Discovery Project Tax Credit (I.R.C. 48D). Oppose the proposed merger between pharmacy benefit managers (PBM) Medco Health Solutions (Medco) and Express Scripts, Inc. (ESI), including comments to the Federal Trade Commission on the merger's obvious danger to older Americans. Support the development of clearly-defined, comprehensive, patient-centric Essential Health Benefits rules under the Affordable Care Act. Support the Counterfeit Drug Penalty Enhancement Act of 2011. 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. Joined other patient advocate organizations January 2012 to urge HHS to ensure that ACA "Essential Health Benefits" guidelines provide comprehensive, quality and affordable health care. This was in response to the HHS December 16, 2011 bulletin on Essential Health Benefits because the HHS bulletin did not provide adequate patient protections as intended under the ACA. Joined other patient advocate groups to support the Spending Reductions through Innovations in Therapies (SPRINT) Act (H.R. 3891 and S. 2064) Support H.R.5998, the USPSTF Transparency and Accountability Act of 2012. Support the creation of the National Center for AdvancingTranslations Sciences' (NCATS) "Discovering New Therapeutic Uses for Existing Molecules Initiative." Support the new Centers for Disease Control recommendations regarding the identification of chronic Hepatitis C infections. Urge all providers and payers to follow those same CDC recommendations. Oppose the substitution and use of unapproved and off-label drugs to treat age-related macular degeneration (AMD). Urge the Department of HHS to adopt the Advisory Council on Alzheimer's Research recommendations and ensure that the final National Alzheimer's Plan includes measures: Providing high-level, overall accountability for National Plan implementation. Recognizing and proposing a path forward to secure the public and private resources needed to achieve all of the goals. Forming robust public-private partnerships between government and industry to inform the research agenda, shorten the time and cost of developing therapies, and accelerate delivery of safe and effective treatments to individuals with Alzheimers. Fostering greater collaboration on research and other issues with international counterparts to achieve global coordination and progress toward a Global Alzheimers Action Plan. Expanding attention on early detection and diagnosis of Alzheimers disease. Ensuring access to the full array of long-term support services for special and emerging populations of people with Alzheimers disease, including younger people and those with developmental disabilities. Addressing caregivers physical and behavioral health. Expanding access to high quality, cost-effective and evidence based care and redoubling efforts to test and validate innovative care interventions. Support extensive clinical trials, manufacturing inspections and post-market surveillance for all biosimilar drugs. Support higher PDUFA fees for biosimilar drugs to pay for the additional safeguards needed. Support stiff restrictions on biosimilar "flexibility" (intentionally introducing differences to the molecule or the finished product) that adds high risk. Support distinctive labeling for safety, and install a strong track and trace system before the first biosimilar is allowed on the market.

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

Support the speedy implementation of the National Alzheimer's Project Act (NAPA) by HHS, and support Leaders Engaged on Alzheimer's Disease (LEAD) recommendations as to how to proceed. Support repeal of Section 6001 of the PPACA and remove all restrictions on physician-owned hospitals. (Support H.R. 1159 and H.R. 1186) Support extensive clinical trials, manufacturing inspections and post-market surveillance for all biosimilar drugs. Support higher PDUFA fees for biosimilar drugs to pay for the additional safeguards needed. Oppose federal budget cuts that would increase co-payments for home health care services under Medicare and/or Medicaid. Support all legislative and regulatory action to modernize the FDA and to speed new cures and therapies to patients. Support the Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011 (S. 1096, H.R. 2020) Support Leaders Engaged on Alzheimer's Disease (LEAD) FY 2012 funding proposals in the amount of for $35 billion for the National Institutes of Health (NIH), $1.4 billion for the National Institute on Aging (NIA), $100 million for the Cures Acceleration Network (CAN), $11.46 million for the Alzheimer's Disease Supportive Services Program (ADSSP), $192 million for the National Family Caregiver Support Program (NFCSP), $50 million for the Lifespan Respite Care Program (LRCP), and$2.744 billion for the Food and Drug Administration (FDA), as well as $2 million for the Missing Alzheimer's Disease Patient Alert Program and $750,000 to organize and host a high-level meeting to focus on the global Alzheimer's disease crisis. Oppose proposals that would reduce Medicare payments for providers of drugs and biologics under Medicare Part B. Support the proposed Prescription Drug User Fee Act Reauthorization Agreement (PDUFA-V) now under consideration by the Congress for reauthorization. Support an extension of the Therapeutic Discovery Project Tax Credit (I.R.C. 48D). Oppose the proposed merger between pharmacy benefit managers (PBM) Medco Health Solutions (Medco) and Express Scripts, Inc. (ESI), including comments to the Federal Trade Commission on the merger's obvious danger to older Americans. Support the development of clearly-defined, comprehensive, patient-centric Essential Health Benefits rules under the Affordable Care Act. Support the Counterfeit Drug Penalty Enhancement Act of 2011. 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. Joined other patient advocate organizations January 2012 to urge HHS to ensure that ACA "Essential Health Benefits" guidelines provide comprehensive, quality and affordable health care. This was in response to the HHS December 16, 2011 bulletin on Essential Health Benefits because the HHS bulletin did not provide adequate patient protections as intended under the ACA. Joined other patient advocate groups to support the Spending Reductions through Innovations in Therapies (SPRINT) Act (H.R. 3891 and S. 2064) Support H.R.5998, the USPSTF Transparency and Accountability Act of 2012. Support the creation of the National Center for AdvancingTranslations Sciences' (NCATS) "Discovering New Therapeutic Uses for Existing Molecules Initiative." Support the new Centers for Disease Control recommendations regarding the identification of chronic Hepatitis C infections. Urge all providers and payers to follow those same CDC recommendations. Oppose the substitution and use of unapproved and off-label drugs to treat age-related macular degeneration (AMD). Urge the Department of HHS to adopt the Advisory Council on Alzheimer's Research recommendations and ensure that the final National Alzheimer's Plan includes measures: Providing high-level, overall accountability for National Plan implementation. Recognizing and proposing a path forward to secure the public and private resources needed to achieve all of the goals. Forming robust public-private partnerships between government and industry to inform the research agenda, shorten the time and cost of developing therapies, and accelerate delivery of safe and effective treatments to individuals with Alzheimers. Fostering greater collaboration on research and other issues with international counterparts to achieve global coordination and progress toward a Global Alzheimers Action Plan. Expanding attention on early detection and diagnosis of Alzheimers disease. Ensuring access to the full array of long-term support services for special and emerging populations of people with Alzheimers disease, including younger people and those with developmental disabilities. Addressing caregivers physical and behavioral health. Expanding access to high quality, cost-effective and evidence based care and redoubling efforts to test and validate innovative care interventions. Support extensive clinical trials, manufacturing inspections and post-market surveillance for all biosimilar drugs. Support higher PDUFA fees for biosimilar drugs to pay for the additional safeguards needed. Support stiff restrictions on biosimilar "flexibility" (intentionally introducing differences to the molecule or the finished product) that adds high risk. Support distinctive labeling for safety, and install a strong track and trace system before the first biosimilar is allowed on the market.

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

S. 1096- The Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act and related Medicare issues

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

Government targets: HOUSE OF REPRESENTATIVES, 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