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Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Medicare Clinical Pharmacist Practitioner Services Coverage Act of 2010
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
H.R. 5389, The Medicare Clinical Pharmacist Practitioner Services Coverage Act of 2010, all provisions. Communications to Environmental Protection Agency on Draft Guidances for Best Management Practices for Unused Pharmaceuticals at Health Care Facilities; Pharmaceutical Waste. Communications to Food and Drug Administration (FDA) on Bar Code Label Requirements; Development and Distribution of Patient Medication Information for Prescription Drugs; and Generic Drug User Fees. Communications to FDA on Distribution of Medication Guide as part of Risk Evaluation and Mitigation Strategies; Approval Pathway for Biosimilars. Communication to Drug Enforcement Administration on Placement of Propofol into Schedule IV Controlled Substance.
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS via AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
2010 · fourth_quarter · Q4
Labor-Health and Human Services Appropriations fiscal years 2010 and 2011. S. 3690, Drug Safety and Accountability Act of 2010, all provisions. H.R.6543, Drug Safety Enhancement Act of 2011. Contacts concerning Food and Drug Administration authority to manage drug shortages. Contacts concerning funding for section 3503 of H.R. 3590, Patient Protection and Affordable Care Act.
H.R. 5389, The Medicare Clinical Pharmacist Practitioner Services Coverage Act of 2010, all provisions. Communications to Environmental Protection Agency on Draft Guidances for Best Management Practices for Unused Pharmaceuticals at Health Care Facilities; Pharmaceutical Waste. Communications to Food and Drug Administration (FDA) on Bar Code Label Requirements; Development and Distribution of Patient Medication Information for Prescription Drugs; and Generic Drug User Fees. Communications to FDA on Distribution of Medication Guide as part of Risk Evaluation and Mitigation Strategies; Approval Pathway for Biosimilars. Communication to Drug Enforcement Administration on Placement of Propofol into Schedule IV Controlled Substance.
Source: Senate LDA
Supported HR 5389, "Medicare Clinical Pharmacist Practitioner Services Coverage Act of 2010," all provisions. Labor-Health and Human Services Appropriations fiscal years 2010 and 2011. H.R. 3590, Patient Protection and Affordable Care Act, Title III, all provisions relating to "medication therapy management," "medical home," and "independence at home." Communication to HHS regarding strategic framework on multiple chronic conditions; Communication to FDA on direct-to-consumer prescription drug advertisements; Meeting with AHRQ to discuss comparative effectiveness research.
Medicare Clinical Pharmacist Practitioner Services Coverage Act of 2010
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
Communications with Food and Drug Admnistration on Risk Evaluation and Mitigation Strategies, reauthorization of the Prescription Drug User Fee Act, medical product recalls, experimental study of patient information prototypes and patient medication information, drug shortages, and generic drug user fees. Communication with Centers for Medicare and Medicaid Services regarding administration of medication to inpatients within 30 minutes of scheduled dosage time. HR 5389, The Medicare Clinical Pharmacist Practitioner Services Coverage Act of 2010, all provisions.
Drug Safety Enhancement Act of 2011
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
Labor-Health and Human Services Appropriations fiscal years 2010 and 2011. S. 3690, Drug Safety and Accountability Act of 2010, all provisions. H.R.6543, Drug Safety Enhancement Act of 2011. Contacts concerning Food and Drug Administration authority to manage drug shortages. Contacts concerning funding for section 3503 of H.R. 3590, Patient Protection and Affordable Care Act.
Drug Safety and Accountability Act of 2010
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
Labor-Health and Human Services Apprpriations fiscal years 2010 and 2011. S. 3690, Drug Safety and Accountability Act of 2010 all provisions. Communication with FDA on the judicious use of medically important antimicrobial drugs in food-producing animals, and the Safe Use Initiative. Communications to Agency for Healthcare Research and Quality regarding comparative effectiveness.
Drug Safety and Accountability Act of 2010
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
Labor-Health and Human Services Appropriations fiscal years 2010 and 2011. S. 3690, Drug Safety and Accountability Act of 2010, all provisions. H.R.6543, Drug Safety Enhancement Act of 2011. Contacts concerning Food and Drug Administration authority to manage drug shortages. Contacts concerning funding for section 3503 of H.R. 3590, Patient Protection and Affordable Care Act.
American Middle Class Tax (AMT) Relief Act of 2007
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
Labor-Health and Human Services Appropriations fiscal years 2010 and 2011. H.R. 3590, Patient Protection and Affordable Care Act, Title III, all provisions relating to "medication therapy management," "medical home," and "independence at home." H.R. 3962, Affordable Health Care for America Act, Title II, all provisions relating to Frontline Health Providers and Loan Forgiveness; Title III, all provisions relating to "medical home" and "independence at home;" Title V, all provisions relating to "medication therapy management." Communications to House and Senate supporting residency funding. Communicatins with FDA regarding the Safe Use Initiative; Communications with FDA regarding inpatient distribution of Medication Guides; Communication with FDA on Transparency Task Force; Communication with FDA on appointment of Special Government Employees.
American Middle Class Tax (AMT) Relief Act of 2007
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
Labor-Health and Human Services Appropriations fiscal years 2010 and 2011. S. 3690, Drug Safety and Accountability Act of 2010, all provisions. H.R.6543, Drug Safety Enhancement Act of 2011. Contacts concerning Food and Drug Administration authority to manage drug shortages. Contacts concerning funding for section 3503 of H.R. 3590, Patient Protection and Affordable Care Act.
Superfund Polluter Pays Act
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
Labor-Health and Human Services Appropriations fiscal years 2010 and 2011. H.R. 3590, Patient Protection and Affordable Care Act, Title III, all provisions relating to "medication therapy management," "medical home," and "independence at home." H.R. 3962, Affordable Health Care for America Act, Title II, all provisions relating to Frontline Health Providers and Loan Forgiveness; Title III, all provisions relating to "medical home" and "independence at home;" Title V, all provisions relating to "medication therapy management." Communications to House and Senate supporting residency funding. Communicatins with FDA regarding the Safe Use Initiative; Communications with FDA regarding inpatient distribution of Medication Guides; Communication with FDA on Transparency Task Force; Communication with FDA on appointment of Special Government Employees.
Access to Frontline Health Care Act of 2009
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
FDA Appropriations FY10. Communication to White House Office on Health Care Reform. Letter and support for HR 2891, Access to Frontline Health Care Act of 2009, all provisions dealing with loan forgiveness for Title VII health professions. Testimony to House Energy and Commerce Committee on HR 3200, support second year specialized residency programs and medication therapy management grant program. Letters to Senate Finance Committee on residency funding.
Access to Frontline Health Care Act of 2009
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
FDA Appropriations FY10. Communication to White House Office on Health Care Reform. Support for HR 2891, Access to Frontline Health Care Act of 2009, all provisions. Support for S 245, Retooling the Healthcare Workforce for an Aging America Act of 2009. Letter urging funding for residency programs in America's Affordable Health Choices Act, HR 3200. Statement to Senate Finance Committee on Healthcare Reform Delivery Options and Coverage Options. Statement to Senate Finance Committee on workforce. Statement to House Energy and Commece Committee on Health Reform. Letters to Senate Finance and Ways and Means Committees on residency funding. Communication with Congressional Budget Office on heatlh care reform. Communication with FDA regarding market withdrawal of morphine sulphate oral solution. Communicatin with FDA on Risk Evaluation and Mititgation Strategies for certain opioid drugs. Communication with NIOSH regarding additions and deltions to hazardous drug list. Communication with FDA regarding safety of acetaminophen-containing drug products.
America's Affordable Health Choices Act of 2009
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
FDA Appropriations FY10. Communication to White House Office on Health Care Reform. Support for HR 2891, Access to Frontline Health Care Act of 2009, all provisions. Support for S 245, Retooling the Healthcare Workforce for an Aging America Act of 2009. Letter urging funding for residency programs in America's Affordable Health Choices Act, HR 3200. Statement to Senate Finance Committee on Healthcare Reform Delivery Options and Coverage Options. Statement to Senate Finance Committee on workforce. Statement to House Energy and Commece Committee on Health Reform. Letters to Senate Finance and Ways and Means Committees on residency funding. Communication with Congressional Budget Office on heatlh care reform. Communication with FDA regarding market withdrawal of morphine sulphate oral solution. Communicatin with FDA on Risk Evaluation and Mititgation Strategies for certain opioid drugs. Communication with NIOSH regarding additions and deltions to hazardous drug list. Communication with FDA regarding safety of acetaminophen-containing drug products.
America's Affordable Health Choices Act of 2009
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
FDA Appropriations FY10. Communication to White House Office on Health Care Reform. Letter and support for HR 2891, Access to Frontline Health Care Act of 2009, all provisions dealing with loan forgiveness for Title VII health professions. Testimony to House Energy and Commerce Committee on HR 3200, support second year specialized residency programs and medication therapy management grant program. Letters to Senate Finance Committee on residency funding.
Retooling the Health Care Workforce for an Aging America Act of 2009
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
FDA Appropriations FY10. Communication to White House Office on Health Care Reform. Support for HR 2891, Access to Frontline Health Care Act of 2009, all provisions. Support for S 245, Retooling the Healthcare Workforce for an Aging America Act of 2009. Letter urging funding for residency programs in America's Affordable Health Choices Act, HR 3200. Statement to Senate Finance Committee on Healthcare Reform Delivery Options and Coverage Options. Statement to Senate Finance Committee on workforce. Statement to House Energy and Commece Committee on Health Reform. Letters to Senate Finance and Ways and Means Committees on residency funding. Communication with Congressional Budget Office on heatlh care reform. Communication with FDA regarding market withdrawal of morphine sulphate oral solution. Communicatin with FDA on Risk Evaluation and Mititgation Strategies for certain opioid drugs. Communication with NIOSH regarding additions and deltions to hazardous drug list. Communication with FDA regarding safety of acetaminophen-containing drug products.
Veterans Health Care Authorization Act of 2009
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
S. 252, Veterans Health Care Authorization of 2009, Title I, all provisions relating to incentive pay for pharmacists. Communications with FDA regarding Risk Evaluation and Mitigation Strategies, Medication Guides, and providing effective information to consumers about prescription drug risks and benefits. Communication with DEA regarding the identification of institution-based individual practitioners.
American Middle Class Tax (AMT) Relief Act of 2007
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
FDA Appropriations FY10. H.R. 3590, Patient Protection and Affordable Care Act, Title III, all provisions relating to "medication therapy management," "medical home," and "independence at home." H.R. 3962, Affordable Health Care for America Act, Title II, all provisions relating to Frontline Health Providers and Loan Forgiveness; Title III all provisions relating to "medical home" and "independence at home;" Title V, all provisions relating to "medication therapy management." Communcations to House and Senate supporting residency funding. Communication with FDA on market withdrawal of unapproved nitroglycerin.
Superfund Polluter Pays Act
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
FDA Appropriations FY10. H.R. 3590, Patient Protection and Affordable Care Act, Title III, all provisions relating to "medication therapy management," "medical home," and "independence at home." H.R. 3962, Affordable Health Care for America Act, Title II, all provisions relating to Frontline Health Providers and Loan Forgiveness; Title III all provisions relating to "medical home" and "independence at home;" Title V, all provisions relating to "medication therapy management." Communcations to House and Senate supporting residency funding. Communication with FDA on market withdrawal of unapproved nitroglycerin.
Access to Life-Saving Medicine Act
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
Health Services and Resources Administration 340 B drug pricing program; proposed guidance on definition of patient, contract pharmacy and participation by children's hospitals. HR 3580, Food and Drug Administration Amendments Act of 2007, titles 8 and 9, all provisins. S.901. Reauthorization of National Health Service Corps. Provisions relating to loan forgiveness programs. Funding for Food and Drug Administration. HR 1956, Patient Protection and Innovative Biologic Medicines Act of 2007 and HR 1038, Access to Life Saving Medicine Act, HR 5629, Pathway for Biosimilars Act, provisions dealing with interchangability. HR 5491, Pharmacy Technician Training and Registration Act of 2008, all provisions. Proposal by FDA for a behind the counter drug category (public meeting and comments). Distribution of patient information and medication guides. Pharmacologic class in patient information. Proposal to transition Mevacor from prescription to over the counter status.
Patient Protection and Innovative Biologic Medicines Act of 2007
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
Health Services and Resources Administration 340 B drug pricing program; proposed guidance on definition of patient, contract pharmacy and participation by children's hospitals. HR 3580, Food and Drug Administration Amendments Act of 2007, titles 8 and 9, all provisins. S.901. Reauthorization of National Health Service Corps. Provisions relating to loan forgiveness programs. Funding for Food and Drug Administration. HR 1956, Patient Protection and Innovative Biologic Medicines Act of 2007 and HR 1038, Access to Life Saving Medicine Act, HR 5629, Pathway for Biosimilars Act, provisions dealing with interchangability. HR 5491, Pharmacy Technician Training and Registration Act of 2008, all provisions. Proposal by FDA for a behind the counter drug category (public meeting and comments). Distribution of patient information and medication guides. Pharmacologic class in patient information. Proposal to transition Mevacor from prescription to over the counter status.
Medicare Prescription Drug Savings for Our Seniors (Medicare Prescription Drug SOS) Act of 2007
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
Ambulatory Payment Classification (APC) Panel testimony and comments. APC Panel Nomination. Letters to CMS and CMS officials regarding compendia additions and deletions including American Hospital Formulary Service-Drug Information. Comments relating to electronic prescribing under Part D. HR 3025, Medicare Prescription Drug Savings for our Seniors Act of 2007 and S1827, Pharmacist Access and Recognition in Medicare (PhARM) Act of 2007; provisions relating to medication therapy management. HR 3162, Children's Health and Medicare Protection Act (CHAMP Act), provisions on comparative effectiveness research. Recognition of pharmacists as health care providers and payment for clinical services. Recognition of AHFS as drug compendia for coverage of unlabeled uses. Funding for specialized pharmacy residency programs. Electronic prescribing.
Food and Drug Administration Amendments Act of 2007
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
Health Services and Resources Administration 340 B drug pricing program; proposed guidance on definition of patient, contract pharmacy and participation by children's hospitals. HR 3580, Food and Drug Administration Amendments Act of 2007, titles 8 and 9, all provisins. S.901. Reauthorization of National Health Service Corps. Provisions relating to loan forgiveness programs. Funding for Food and Drug Administration. HR 1956, Patient Protection and Innovative Biologic Medicines Act of 2007 and HR 1038, Access to Life Saving Medicine Act, HR 5629, Pathway for Biosimilars Act, provisions dealing with interchangability. HR 5491, Pharmacy Technician Training and Registration Act of 2008, all provisions. Proposal by FDA for a behind the counter drug category (public meeting and comments). Distribution of patient information and medication guides. Pharmacologic class in patient information. Proposal to transition Mevacor from prescription to over the counter status.
Pharmacy Technician Training and Registration Act of 2008
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
Health Services and Resources Administration 340 B drug pricing program; proposed guidance on definition of patient, contract pharmacy and participation by children's hospitals. HR 3580, Food and Drug Administration Amendments Act of 2007, titles 8 and 9, all provisins. S.901. Reauthorization of National Health Service Corps. Provisions relating to loan forgiveness programs. Funding for Food and Drug Administration. HR 1956, Patient Protection and Innovative Biologic Medicines Act of 2007 and HR 1038, Access to Life Saving Medicine Act, HR 5629, Pathway for Biosimilars Act, provisions dealing with interchangability. HR 5491, Pharmacy Technician Training and Registration Act of 2008, all provisions. Proposal by FDA for a behind the counter drug category (public meeting and comments). Distribution of patient information and medication guides. Pharmacologic class in patient information. Proposal to transition Mevacor from prescription to over the counter status.
Pharmacy Technician Training and Registration Act of 2008
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
S. 901, Health Centers Renewal Act of 2007 and S.2708, Caring for an Aging America Act of 2008. Include pharmacists as eligible for loan forgiveness programs of the National Health Service Corps. S.2932, Poison Center Support, Enhancement, and Awareness Act of 2008 support all provisions. H.R. 5491, The Pharmacy Technician Training and Registration Act of 2008; all provisions. Comments relating to standards and technologies for numerical identifier, validation, track and trace, and authentication for prescription drugs. Comments on Direct-to-Consumer Advertising. Comments on proposed National Institute for Occupational Safety and Health survey of healthcare workers' safety and health. Meetings with HRSA officials on general and common issues on pharmacy technicians, telepharmacy, loan forgiveness.
Pharmacy Technician Training and Registration Act of 2008
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
S. 901, Health Centers Renewal Act of 2007, include pharmacists as eligible for loan forgiveness programs of the National Health Service Corps. S.2708, Caring for an Aging America Act of 2008, include pharmacists in geriatric training program. Proposed legislation to create an academic counterdetailing program on prescription drugs. Outlined potential role of the pahrmacist. S. 2932, Poison Center Support, Enhancement, and Awareness of 2008, support all provisions. H.R. 5491, The Pharmacy Technician Training and Registration Act of 2008; all provisions. FDA: Communicated policy concerning National Drug Code number system and need for improvements. DEA: proposed rule concerning electronic prescriptions for controlled substances. Comments to the Office of the Natinal Coordinator for Health Information Technology re: Draft Medication Gaps and Draft Order Sets.
Pathway for Biosimilars Act
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
Health Services and Resources Administration 340 B drug pricing program; proposed guidance on definition of patient, contract pharmacy and participation by children's hospitals. HR 3580, Food and Drug Administration Amendments Act of 2007, titles 8 and 9, all provisins. S.901. Reauthorization of National Health Service Corps. Provisions relating to loan forgiveness programs. Funding for Food and Drug Administration. HR 1956, Patient Protection and Innovative Biologic Medicines Act of 2007 and HR 1038, Access to Life Saving Medicine Act, HR 5629, Pathway for Biosimilars Act, provisions dealing with interchangability. HR 5491, Pharmacy Technician Training and Registration Act of 2008, all provisions. Proposal by FDA for a behind the counter drug category (public meeting and comments). Distribution of patient information and medication guides. Pharmacologic class in patient information. Proposal to transition Mevacor from prescription to over the counter status.
Medicare Improvements for Patients and Providers Act of 2008
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
H.R. 6331, Medicare Improvements for Patients and Providers Act of 2008, Title I Section 182, provision that revises definition of medically accepted indication for drugs and conflicts of interest. Communication and meetings with CMS staff regarding compendia recognition. Presentation and written testimony before CMS' Ambulatory Payment Classification Panel regarding pharmacy overhead Comments to CMS re: Hospital Outpatient Prospective Payment System and 2009 Payment rates. Communications with CMS re: Conditions of Participation and Interpretive Guidance regarding standing orders and protocols. Comments to CMS re: e-prescribing exemption for computer generated facsimile transmissions.
Medicare Improvements for Patients and Providers Act of 2008
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
H.R. 6331, Medicare Improvements for Patients and Providers Act of 2008, Title I, Section 182, Provision that revises definition of medically accepted indication for drugs and conflic of interest. Comments on proposed changes to the Hospital Inpatient Prospective Payment Systems and FY 2009 Rates-Proposed Rule.
Medicare Improvements for Patients and Providers Act of 2008
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
H.R. 6331, Medicare Improvements for Patients and Providers Act of 2008, Title I, Section 182, provision that revises definition of medically accepted indication for drugs and conflicts of interest. Communication and meetings with CMS staff regarding compendia recognition. Presentation & written testimony before CMS Ambulatory Payment Classification Panel regarding pharmacy overhead. Comments to CMS re: Hospital Outpatient Prospective Payment System and 2009 payment rates and 340B Drug Pricing Program. Communications with CMS re:Conditions of Participation and Interpretive Guidance regarding standing orders and protocols. Communications with CMS re: billing for pharmacist services in hospital-based anticoagulation clinics.
Pharmacist Access and Recognition in Medicare (PhARM) Act of 2007
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
Ambulatory Payment Classification (APC) Panel testimony and comments. APC Panel Nomination. Letters to CMS and CMS officials regarding compendia additions and deletions including American Hospital Formulary Service-Drug Information. Comments relating to electronic prescribing under Part D. HR 3025, Medicare Prescription Drug Savings for our Seniors Act of 2007 and S1827, Pharmacist Access and Recognition in Medicare (PhARM) Act of 2007; provisions relating to medication therapy management. HR 3162, Children's Health and Medicare Protection Act (CHAMP Act), provisions on comparative effectiveness research. Recognition of pharmacists as health care providers and payment for clinical services. Recognition of AHFS as drug compendia for coverage of unlabeled uses. Funding for specialized pharmacy residency programs. Electronic prescribing.
Caring for an Aging America Act of 2008
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
S. 901, Health Centers Renewal Act of 2007, include pharmacists as eligible for loan forgiveness programs of the National Health Service Corps. S.2708, Caring for an Aging America Act of 2008, include pharmacists in geriatric training program. Proposed legislation to create an academic counterdetailing program on prescription drugs. Outlined potential role of the pahrmacist. S. 2932, Poison Center Support, Enhancement, and Awareness of 2008, support all provisions. H.R. 5491, The Pharmacy Technician Training and Registration Act of 2008; all provisions. FDA: Communicated policy concerning National Drug Code number system and need for improvements. DEA: proposed rule concerning electronic prescriptions for controlled substances. Comments to the Office of the Natinal Coordinator for Health Information Technology re: Draft Medication Gaps and Draft Order Sets.
Caring for an Aging America Act of 2008
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
S.901, Health Centers Renewal Act of 2007, include pharmacists as eligible for loan forgiveness programs of the Natinal Health Service Corps. S.2708, Caring for an Aging America Act of 2008, include pharmacists in geriatric training program. Proposed legislation to create an academic counterdetailing program on prescription drugs. Outlined potential role of the pharmacist. S.2932, Poison Center Support, Enhancement and Awareness Act of 2008, support all provisions. Communication to FDA on NDC number.
Caring for an Aging America Act of 2008
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
S. 901, Health Centers Renewal Act of 2007 and S.2708, Caring for an Aging America Act of 2008. Include pharmacists as eligible for loan forgiveness programs of the National Health Service Corps. S.2932, Poison Center Support, Enhancement, and Awareness Act of 2008 support all provisions. H.R. 5491, The Pharmacy Technician Training and Registration Act of 2008; all provisions. Comments relating to standards and technologies for numerical identifier, validation, track and trace, and authentication for prescription drugs. Comments on Direct-to-Consumer Advertising. Comments on proposed National Institute for Occupational Safety and Health survey of healthcare workers' safety and health. Meetings with HRSA officials on general and common issues on pharmacy technicians, telepharmacy, loan forgiveness.
Poison Center Support, Enhancement, and Awareness Act of 2008
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
S.901, Health Centers Renewal Act of 2007, include pharmacists as eligible for loan forgiveness programs of the Natinal Health Service Corps. S.2708, Caring for an Aging America Act of 2008, include pharmacists in geriatric training program. Proposed legislation to create an academic counterdetailing program on prescription drugs. Outlined potential role of the pharmacist. S.2932, Poison Center Support, Enhancement and Awareness Act of 2008, support all provisions. Communication to FDA on NDC number.
Poison Center Support, Enhancement, and Awareness Act of 2008
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
S. 901, Health Centers Renewal Act of 2007, include pharmacists as eligible for loan forgiveness programs of the National Health Service Corps. S.2708, Caring for an Aging America Act of 2008, include pharmacists in geriatric training program. Proposed legislation to create an academic counterdetailing program on prescription drugs. Outlined potential role of the pahrmacist. S. 2932, Poison Center Support, Enhancement, and Awareness of 2008, support all provisions. H.R. 5491, The Pharmacy Technician Training and Registration Act of 2008; all provisions. FDA: Communicated policy concerning National Drug Code number system and need for improvements. DEA: proposed rule concerning electronic prescriptions for controlled substances. Comments to the Office of the Natinal Coordinator for Health Information Technology re: Draft Medication Gaps and Draft Order Sets.
Poison Center Support, Enhancement, and Awareness Act of 2008
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
S. 901, Health Centers Renewal Act of 2007 and S.2708, Caring for an Aging America Act of 2008. Include pharmacists as eligible for loan forgiveness programs of the National Health Service Corps. S.2932, Poison Center Support, Enhancement, and Awareness Act of 2008 support all provisions. H.R. 5491, The Pharmacy Technician Training and Registration Act of 2008; all provisions. Comments relating to standards and technologies for numerical identifier, validation, track and trace, and authentication for prescription drugs. Comments on Direct-to-Consumer Advertising. Comments on proposed National Institute for Occupational Safety and Health survey of healthcare workers' safety and health. Meetings with HRSA officials on general and common issues on pharmacy technicians, telepharmacy, loan forgiveness.
Health Care Safety Net Act of 2007
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
S. 901, Health Centers Renewal Act of 2007, include pharmacists as eligible for loan forgiveness programs of the National Health Service Corps. S.2708, Caring for an Aging America Act of 2008, include pharmacists in geriatric training program. Proposed legislation to create an academic counterdetailing program on prescription drugs. Outlined potential role of the pahrmacist. S. 2932, Poison Center Support, Enhancement, and Awareness of 2008, support all provisions. H.R. 5491, The Pharmacy Technician Training and Registration Act of 2008; all provisions. FDA: Communicated policy concerning National Drug Code number system and need for improvements. DEA: proposed rule concerning electronic prescriptions for controlled substances. Comments to the Office of the Natinal Coordinator for Health Information Technology re: Draft Medication Gaps and Draft Order Sets.
Health Care Safety Net Act of 2007
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
S.901, Health Centers Renewal Act of 2007, include pharmacists as eligible for loan forgiveness programs of the Natinal Health Service Corps. S.2708, Caring for an Aging America Act of 2008, include pharmacists in geriatric training program. Proposed legislation to create an academic counterdetailing program on prescription drugs. Outlined potential role of the pharmacist. S.2932, Poison Center Support, Enhancement and Awareness Act of 2008, support all provisions. Communication to FDA on NDC number.
Health Care Safety Net Act of 2007
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
Health Services and Resources Administration 340 B drug pricing program; proposed guidance on definition of patient, contract pharmacy and participation by children's hospitals. HR 3580, Food and Drug Administration Amendments Act of 2007, titles 8 and 9, all provisins. S.901. Reauthorization of National Health Service Corps. Provisions relating to loan forgiveness programs. Funding for Food and Drug Administration. HR 1956, Patient Protection and Innovative Biologic Medicines Act of 2007 and HR 1038, Access to Life Saving Medicine Act, HR 5629, Pathway for Biosimilars Act, provisions dealing with interchangability. HR 5491, Pharmacy Technician Training and Registration Act of 2008, all provisions. Proposal by FDA for a behind the counter drug category (public meeting and comments). Distribution of patient information and medication guides. Pharmacologic class in patient information. Proposal to transition Mevacor from prescription to over the counter status.
Health Care Safety Net Act of 2007
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
S. 901, Health Centers Renewal Act of 2007 and S.2708, Caring for an Aging America Act of 2008. Include pharmacists as eligible for loan forgiveness programs of the National Health Service Corps. S.2932, Poison Center Support, Enhancement, and Awareness Act of 2008 support all provisions. H.R. 5491, The Pharmacy Technician Training and Registration Act of 2008; all provisions. Comments relating to standards and technologies for numerical identifier, validation, track and trace, and authentication for prescription drugs. Comments on Direct-to-Consumer Advertising. Comments on proposed National Institute for Occupational Safety and Health survey of healthcare workers' safety and health. Meetings with HRSA officials on general and common issues on pharmacy technicians, telepharmacy, loan forgiveness.
To suspend temporarily the duty on Procion Yellow H-EXL.
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
H.R. 2642, Iraq War Supplemental Appropriations, support additional appropriations for Food and Drug Administration. Communications to FDA staff regarding gluten labeling on medications; Risk Communication Advisory Committee meeting; maintaining HFA designation on labeling. Meeting with FDA Chief of Staff; Communication to FDA re: testimony before joint meeting of the Antiviral Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee; Comments to FDA re concept paper on evaluating proposed drug name submissions. Comments to FDA on content and format labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling; Communication re; nominations to FDA advisory committee
To suspend temporarily the duty on Procion Yellow H-EXL.
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
H.R. 2642, Iraq War Supplemental Appropriations, support additional appropriations for Food and Drug Administration. Comments on Draft Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unaproved new Uses of Approved Drugs and Approved or Cleared Medical Devices. Comments on Draft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan; Communications to FDA staff regarding request for feedback on FDA's unapproved drug initiative. Communication with FDA staff regarding behind-the-counter availability of certain drugs. Comments on Patient Safety and Quality Improvement-Notice of Proposed Rulemaking. Nominations to National Advisory Council for Healthcare Research and Quality. Comments on designation of Medically Underserved Populations and Health Professional Shortage Areas Notice of Proposed Rulemaking.
To suspend temporarily the duty on Procion Yellow H-EXL.
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
H.R.2642, Iraq War Supplemental Appropriations, additional appropriations for Food and Drug Administration. Communications to FDA staff regarding gluten labeling on medications; nominations to FDA Advisory Committees;MedWatch Partners and electronic data collection; Best Practices for Distribution of Antivirals for Pandemic Influenza: Public Health Impact and Research Recommendations. Communication with FDA concerning the phased removal of propoxyphene from the market.
To require cigarette products to be placed under or behind the counter in retail sales.
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
Ambulatory Payment Classification (APC) Panel testimony and comments. APC Panel Nomination. Letters to CMS and CMS officials regarding compendia additions and deletions including American Hospital Formulary Service-Drug Information. Comments relating to electronic prescribing under Part D. HR 3025, Medicare Prescription Drug Savings for our Seniors Act of 2007 and S1827, Pharmacist Access and Recognition in Medicare (PhARM) Act of 2007; provisions relating to medication therapy management. HR 3162, Children's Health and Medicare Protection Act (CHAMP Act), provisions on comparative effectiveness research. Recognition of pharmacists as health care providers and payment for clinical services. Recognition of AHFS as drug compendia for coverage of unlabeled uses. Funding for specialized pharmacy residency programs. Electronic prescribing.
Access to Life-Saving Medicine Act
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
HR 3580, Food and Drug Administration Amendments Act of 2007, titles 8 and 9, all provisions. S.901, Reauthorization of National Health Service Corps, provisions relating to loan forgiveness programs. Funding for Food and Drug Admnistration. HR1956, Patient Protection and Innovative Biologic Medicines Act of 2007 and HR1038, Access to Life Saving Medicine Act, provisions dealing with interchangability. Proposal by FDA for a behind the counter drug category (public meeting and comments). Electronic
Patient Protection and Innovative Biologic Medicines Act of 2007
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
HR 3580, Food and Drug Administration Amendments Act of 2007, titles 8 and 9, all provisions. S.901, Reauthorization of National Health Service Corps, provisions relating to loan forgiveness programs. Funding for Food and Drug Admnistration. HR1956, Patient Protection and Innovative Biologic Medicines Act of 2007 and HR1038, Access to Life Saving Medicine Act, provisions dealing with interchangability. Proposal by FDA for a behind the counter drug category (public meeting and comments). Electronic
Medicare Prescription Drug Savings for Our Seniors (Medicare Prescription Drug SOS) Act of 2007
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
Requirement to report National Drug Code Number to State Medicaid agencies (provision in Deficit Reduction Act.) H.R. 3090, provision delaying date requiring tamper resistant prescriptions. HR 3025, Medicare Prescription Drug Savings for our Seniors Act of 2007 and S1827, Pharmacist Access and Recognition in Medicare (PhARM) Act of 2007; provisions relating to medication therapy management.
Patient and Pharmacy Protection Act of 2007
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
Requirement to report National Drug Code Number to State Medicaid agencies (provision in Deficit Reduction Act.) H.R. 3090, provision delaying date requiring tamper resistant prescriptions. HR 3025, Medicare Prescription Drug Savings for our Seniors Act of 2007 and S1827, Pharmacist Access and Recognition in Medicare (PhARM) Act of 2007; provisions relating to medication therapy management.
Food and Drug Administration Amendments Act of 2007
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
HR 3580, Food and Drug Administration Amendments Act of 2007, titles 8 and 9, all provisions. S.901, Reauthorization of National Health Service Corps, provisions relating to loan forgiveness programs. Funding for Food and Drug Admnistration. HR1956, Patient Protection and Innovative Biologic Medicines Act of 2007 and HR1038, Access to Life Saving Medicine Act, provisions dealing with interchangability. Proposal by FDA for a behind the counter drug category (public meeting and comments). Electronic
Pharmacist Access and Recognition in Medicare (PhARM) Act of 2007
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
Requirement to report National Drug Code Number to State Medicaid agencies (provision in Deficit Reduction Act.) H.R. 3090, provision delaying date requiring tamper resistant prescriptions. HR 3025, Medicare Prescription Drug Savings for our Seniors Act of 2007 and S1827, Pharmacist Access and Recognition in Medicare (PhARM) Act of 2007; provisions relating to medication therapy management.
Health Care Safety Net Act of 2007
Client: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · Firm: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
HR 3580, Food and Drug Administration Amendments Act of 2007, titles 8 and 9, all provisions. S.901, Reauthorization of National Health Service Corps, provisions relating to loan forgiveness programs. Funding for Food and Drug Admnistration. HR1956, Patient Protection and Innovative Biologic Medicines Act of 2007 and HR1038, Access to Life Saving Medicine Act, provisions dealing with interchangability. Proposal by FDA for a behind the counter drug category (public meeting and comments). Electronic
Communication with Centers for Medicare and Medicaid Services (CMS) regarding admnistration of medication to inpatients within 30 minutes of scheduled dosage time. Communication with CMS regarding Accountable Care Organizations and the Shared Savings Program.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS via AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
2010 · third_quarter · Q3
Communications with Food and Drug Admnistration on Risk Evaluation and Mitigation Strategies, reauthorization of the Prescription Drug User Fee Act, medical product recalls, experimental study of patient information prototypes and patient medication information, drug shortages, and generic drug user fees. Communication with Centers for Medicare and Medicaid Services regarding administration of medication to inpatients within 30 minutes of scheduled dosage time. HR 5389, The Medicare Clinical Pharmacist Practitioner Services Coverage Act of 2010, all provisions.
Labor-Health and Human Services Apprpriations fiscal years 2010 and 2011. S. 3690, Drug Safety and Accountability Act of 2010 all provisions. Communication with FDA on the judicious use of medically important antimicrobial drugs in food-producing animals, and the Safe Use Initiative. Communications to Agency for Healthcare Research and Quality regarding comparative effectiveness.
Communication with Centers for Medicare and Medicaid Services on hospital outpatient prospective payment system, and the physician fee schedule for calendar year 2011. Communication with CMS and House and Senate funding regarding specialized pharmacy residency programs.
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS via AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
2010 · second_quarter · Q2
Communication with CMS on funding for specialized pharmacy residency programs; communication with the Office of the National Coordinator for Health Information Technology on certification programs for health information technology; communication to CMS regarding counseling to prevent tobacco use; communication to CMS on the hospital inpatient prospective payment system.
Supported HR 5389, "Medicare Clinical Pharmacist Practitioner Services Coverage Act of 2010," all provisions. Labor-Health and Human Services Appropriations fiscal years 2010 and 2011. H.R. 3590, Patient Protection and Affordable Care Act, Title III, all provisions relating to "medication therapy management," "medical home," and "independence at home." Communication to HHS regarding strategic framework on multiple chronic conditions; Communication to FDA on direct-to-consumer prescription drug advertisements; Meeting with AHRQ to discuss comparative effectiveness research.
Communications with FDA on Risk Evaluation and Mitigation Strategies and Prescription Drug User Fee Act reauthorization; communication with Office of Pharmacy Affairs, Health Resources and Services Administration on 340B drug pricing program, transition to new Director of Office of Pharmacy Affairs, Patient Safety and Clinical Services Collaborative, status of patient definition guidelines, increased federal funds for community health centers, National Healthcare Workforce Commission; Commmunication with FDA on distribution of medication guides in the inpatient setting; communication with FDA on drug recalls; communication with DEA on electronic prescriptions for controlled substances; meeting with HRSA's Office of Rural Health Policy to discuss medication therapy management, workforce commission, patient safety collaborative, telepharmacy, 340B and health IT.
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE
AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS via AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
2010 · first_quarter · Q1
Communication with FDA regarding the quality of compounded drugs and improving stakeholder communications; Communications to the Agency for Healthcare Research and Quality regarding nominations to Effective Healthcare Stakeholder Group; Communication with FDA on Risk Evaluation and Mitigation Strategies and Prescription Drug User Fee Act Reauthorization Public Meeting.
Labor-Health and Human Services Appropriations fiscal years 2010 and 2011. H.R. 3590, Patient Protection and Affordable Care Act, Title III, all provisions relating to "medication therapy management," "medical home," and "independence at home." H.R. 3962, Affordable Health Care for America Act, Title II, all provisions relating to Frontline Health Providers and Loan Forgiveness; Title III, all provisions relating to "medical home" and "independence at home;" Title V, all provisions relating to "medication therapy management." Communications to House and Senate supporting residency funding. Communicatins with FDA regarding the Safe Use Initiative; Communications with FDA regarding inpatient distribution of Medication Guides; Communication with FDA on Transparency Task Force; Communication with FDA on appointment of Special Government Employees.
Communication with Centers for Medicare and Medicaid Services on chemotherapy administration codes, physician supervision requirements, and anticoagulation billing issue; Communications to CMS and Office of the National Coordinator for Health Information Technology on issues relating to health information technology and meaningful use.
Communication to the Environmental Protection Agency on Preliminary 2010 Effluent Guidelines Program Plan and the disposal of unused pharmaceuticals.
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS via AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
2009 · fourth_quarter · Q4
Communication to Employment and Training Administration relating to awarding competitive grants for worker training to ASHP-accredited pharmacy technician training programs. Communication to National Institute for Occupational Safety and Health relating to temporary assignment for health care workers who work with hazardous drugs.
FDA Appropriations FY10. H.R. 3590, Patient Protection and Affordable Care Act, Title III, all provisions relating to "medication therapy management," "medical home," and "independence at home." H.R. 3962, Affordable Health Care for America Act, Title II, all provisions relating to Frontline Health Providers and Loan Forgiveness; Title III all provisions relating to "medical home" and "independence at home;" Title V, all provisions relating to "medication therapy management." Communcations to House and Senate supporting residency funding. Communication with FDA on market withdrawal of unapproved nitroglycerin.
S. 252, Veterans Health Care Authorization of 2009, Title I, all provisions relating to incentive pay for pharmacists. Communications with FDA regarding Risk Evaluation and Mitigation Strategies, Medication Guides, and providing effective information to consumers about prescription drug risks and benefits. Communication with DEA regarding the identification of institution-based individual practitioners.
Filing targets: Centers For Disease Control & Prevention (CDC), Drug Enforcement Administration (DEA), Employment & Training Administration, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS via AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
2009 · third_quarter · Q3
Meeting with FDA relating to removal of unapproved products, opportunities for future collaboration; Risk Evaluation and Mitigation Strategies. Meeting with FDA regarding design and use of NDC number.
Communication with Healthcare Information Technology Standards Panel Secretariat regarding HITSP Quality Interoperability Specification; Communication to Centers for Medicare and Medicaid Services in support of Joint Commission application for continued deeming authority for hospitals; Communications with CMS on the Hospital Outpatient Prospective Payment System; Communication with CMS on the Physician Fee Schedule; Meeting with CMS on compendia issues.
AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS via AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
2009 · second_quarter · Q2
Communication with FDA and HHS regarding standards for securing the drug supply chain and the National Drug Code system. Communication with the Office of the National Coordinator regarding "Draft Use of Electronic Health Records in Clinical Research. Communication with Food and Drug Administration on evaluation of consumer medication information. Communication with Health Resources and Services Administration on National Quality Forum priorities and pharmacist residency training and workforce issues. Comments to Office of the National Coordinator regarding health information technology extension program. Communication with Drug Enforcement Administration regarding implementation of Ryan Haight Online Pharmacy Consumer Protection Act of 2008. Communication with Centers for Medicare and Medicaid Services regarding anticoagulation clinic billing issue.
Communication with EPA regarding health care industry study on practices related to disposal of unused pharmaceuticals.
AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS via AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
2009 · first_quarter · Q1
HR 1, American Recovery and Reinvestment Act, Title XIII, Health information technology provisions. FDA appropriations FY09 & FY10. Communication re: confirmation of Secretary-Designate Daschle, and Sebelius. Communication to White House Office regarding health care reform. Statement to Senate Finance Committee on workforce and health care reform. Health care reform (no bill #). Letter to Office of the Nat. Coordinator for Health Information Technology regarding Standards Committee appointment.
Communication seeking withdrawal of propxyphene from the market. Communication re: experimental study of consumer reporting of side effects as part of direct-to-consumer advertising. Communication re: evaluation and usefulness of consumer medication information. Communication re: FDA's Sentinal Initiative to monitor medical product safety. Comments on disposal of controlled substances.
AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS via AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
2008 · fourth_quarter · Q4
S.901, Health Centers Renewal Act of 2007, include pharmacists as eligible for loan forgiveness programs of the Natinal Health Service Corps. S.2708, Caring for an Aging America Act of 2008, include pharmacists in geriatric training program. Proposed legislation to create an academic counterdetailing program on prescription drugs. Outlined potential role of the pharmacist. S.2932, Poison Center Support, Enhancement and Awareness Act of 2008, support all provisions. Communication to FDA on NDC number.
H.R.2642, Iraq War Supplemental Appropriations, additional appropriations for Food and Drug Administration. Communications to FDA staff regarding gluten labeling on medications; nominations to FDA Advisory Committees;MedWatch Partners and electronic data collection; Best Practices for Distribution of Antivirals for Pandemic Influenza: Public Health Impact and Research Recommendations. Communication with FDA concerning the phased removal of propoxyphene from the market.
AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS via AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
2008 · third_quarter · Q3
H.R. 2642, Iraq War Supplemental Appropriations, support additional appropriations for Food and Drug Administration. Communications to FDA staff regarding gluten labeling on medications; Risk Communication Advisory Committee meeting; maintaining HFA designation on labeling. Meeting with FDA Chief of Staff; Communication to FDA re: testimony before joint meeting of the Antiviral Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee; Comments to FDA re concept paper on evaluating proposed drug name submissions. Comments to FDA on content and format labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling; Communication re; nominations to FDA advisory committee
S. 901, Health Centers Renewal Act of 2007, include pharmacists as eligible for loan forgiveness programs of the National Health Service Corps. S.2708, Caring for an Aging America Act of 2008, include pharmacists in geriatric training program. Proposed legislation to create an academic counterdetailing program on prescription drugs. Outlined potential role of the pahrmacist. S. 2932, Poison Center Support, Enhancement, and Awareness of 2008, support all provisions. H.R. 5491, The Pharmacy Technician Training and Registration Act of 2008; all provisions. FDA: Communicated policy concerning National Drug Code number system and need for improvements. DEA: proposed rule concerning electronic prescriptions for controlled substances. Comments to the Office of the Natinal Coordinator for Health Information Technology re: Draft Medication Gaps and Draft Order Sets.
AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS via AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
2008 · second_quarter · Q2
S. 901, Health Centers Renewal Act of 2007 and S.2708, Caring for an Aging America Act of 2008. Include pharmacists as eligible for loan forgiveness programs of the National Health Service Corps. S.2932, Poison Center Support, Enhancement, and Awareness Act of 2008 support all provisions. H.R. 5491, The Pharmacy Technician Training and Registration Act of 2008; all provisions. Comments relating to standards and technologies for numerical identifier, validation, track and trace, and authentication for prescription drugs. Comments on Direct-to-Consumer Advertising. Comments on proposed National Institute for Occupational Safety and Health survey of healthcare workers' safety and health. Meetings with HRSA officials on general and common issues on pharmacy technicians, telepharmacy, loan forgiveness.
H.R. 6331, Medicare Improvements for Patients and Providers Act of 2008, Title I, Section 182, Provision that revises definition of medically accepted indication for drugs and conflic of interest. Comments on proposed changes to the Hospital Inpatient Prospective Payment Systems and FY 2009 Rates-Proposed Rule.
AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS via AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
2008 · first_quarter · Q1
FDA: Adverse event collection workshop and comments. Comments on FDA Science and Technology Report. Standard setting for pharmaceutical supply chain issues including radio frequency identification.
Health Services and Resources Administration 340 B drug pricing program; proposed guidance on definition of patient, contract pharmacy and participation by children's hospitals. HR 3580, Food and Drug Administration Amendments Act of 2007, titles 8 and 9, all provisins. S.901. Reauthorization of National Health Service Corps. Provisions relating to loan forgiveness programs. Funding for Food and Drug Administration. HR 1956, Patient Protection and Innovative Biologic Medicines Act of 2007 and HR 1038, Access to Life Saving Medicine Act, HR 5629, Pathway for Biosimilars Act, provisions dealing with interchangability. HR 5491, Pharmacy Technician Training and Registration Act of 2008, all provisions. Proposal by FDA for a behind the counter drug category (public meeting and comments). Distribution of patient information and medication guides. Pharmacologic class in patient information. Proposal to transition Mevacor from prescription to over the counter status.
AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS via AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
2007 · year_end · YY
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE
AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS via AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
2007 · year_end · YY
HR 3580, Food and Drug Administration Amendments Act of 2007, titles 8 and 9, all provisions. S.901, Reauthorization of National Health Service Corps, provisions relating to loan forgiveness programs. Funding for Food and Drug Admnistration. HR1956, Patient Protection and Innovative Biologic Medicines Act of 2007 and HR1038, Access to Life Saving Medicine Act, provisions dealing with interchangability. Proposal by FDA for a behind the counter drug category (public meeting and comments). Electronic
Requirement to report National Drug Code Number to State Medicaid agencies (provision in Deficit Reduction Act.) H.R. 3090, provision delaying date requiring tamper resistant prescriptions. HR 3025, Medicare Prescription Drug Savings for our Seniors Act of 2007 and S1827, Pharmacist Access and Recognition in Medicare (PhARM) Act of 2007; provisions relating to medication therapy management.
AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS via AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
2007 · mid_year · MM
Pharmacy compounding; Drug safety and post-marketing surveillance; Medication therapy management programs; Restricted drug distribution systems; Prescription Drug User Fee Act reauthorization; Minimum effective doses; Prohibiting re-use of brand names; Generic biologics
Medication error reporting; cost-effectiveness of medications; FDA appropriations; comparative effectiveness research; counterfeit drugs; Prescription Drug User Fee Act reauthorization; direct-to-consumer advertising;
Medicare Part D Implementation; Deficit Reduction Act Implementation; Payment formulas for Part B, outpatient and inpatient prospective payment systems; 340B drug pricing program; Payment for pharmacist services
FDA Appropriations FY10. Communication to White House Office on Health Care Reform. Letter and support for HR 2891, Access to Frontline Health Care Act of 2009, all provisions dealing with loan forgiveness for Title VII health professions. Testimony to House Energy and Commerce Committee on HR 3200, support second year specialized residency programs and medication therapy management grant program. Letters to Senate Finance Committee on residency funding.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
FDA Appropriations FY10. Communication to White House Office on Health Care Reform. Support for HR 2891, Access to Frontline Health Care Act of 2009, all provisions. Support for S 245, Retooling the Healthcare Workforce for an Aging America Act of 2009. Letter urging funding for residency programs in America's Affordable Health Choices Act, HR 3200. Statement to Senate Finance Committee on Healthcare Reform Delivery Options and Coverage Options. Statement to Senate Finance Committee on workforce. Statement to House Energy and Commece Committee on Health Reform. Letters to Senate Finance and Ways and Means Committees on residency funding. Communication with Congressional Budget Office on heatlh care reform. Communication with FDA regarding market withdrawal of morphine sulphate oral solution. Communicatin with FDA on Risk Evaluation and Mititgation Strategies for certain opioid drugs. Communication with NIOSH regarding additions and deltions to hazardous drug list. Communication with FDA regarding safety of acetaminophen-containing drug products.
Communication with CMS on Hospital Inpatient Prospective Payment System. Communication with Office of the National Coordinator on Health Information Technology regarding definition of "meaningful use."
Filing targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, White House Office
Communication and meetings with CMS staff regarding compendia recognition. Presentation and written testimony before CMS Ambulatory Payment Classification Panel regarding pharmacy overhead. Communication to CMS re: nomination to APC panel. Comments to CMS re: 2010 call letter concerning Part D medication therapy management programs. Communication to CMS regarding payment policy for outpatient anticoagulation services.
Communication to Environmental Protection Agency regarding addition of pharmaceuticals to universal waste rule.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
H.R. 6331, Medicare Improvements for Patients and Providers Act of 2008, Title I, Section 182, provision that revises definition of medically accepted indication for drugs and conflicts of interest. Communication and meetings with CMS staff regarding compendia recognition. Presentation & written testimony before CMS Ambulatory Payment Classification Panel regarding pharmacy overhead. Comments to CMS re: Hospital Outpatient Prospective Payment System and 2009 payment rates and 340B Drug Pricing Program. Communications with CMS re:Conditions of Participation and Interpretive Guidance regarding standing orders and protocols. Communications with CMS re: billing for pharmacist services in hospital-based anticoagulation clinics.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
H.R. 6331, Medicare Improvements for Patients and Providers Act of 2008, Title I Section 182, provision that revises definition of medically accepted indication for drugs and conflicts of interest. Communication and meetings with CMS staff regarding compendia recognition. Presentation and written testimony before CMS' Ambulatory Payment Classification Panel regarding pharmacy overhead Comments to CMS re: Hospital Outpatient Prospective Payment System and 2009 Payment rates. Communications with CMS re: Conditions of Participation and Interpretive Guidance regarding standing orders and protocols. Comments to CMS re: e-prescribing exemption for computer generated facsimile transmissions.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
H.R. 2642, Iraq War Supplemental Appropriations, support additional appropriations for Food and Drug Administration. Comments on Draft Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unaproved new Uses of Approved Drugs and Approved or Cleared Medical Devices. Comments on Draft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan; Communications to FDA staff regarding request for feedback on FDA's unapproved drug initiative. Communication with FDA staff regarding behind-the-counter availability of certain drugs. Comments on Patient Safety and Quality Improvement-Notice of Proposed Rulemaking. Nominations to National Advisory Council for Healthcare Research and Quality. Comments on designation of Medically Underserved Populations and Health Professional Shortage Areas Notice of Proposed Rulemaking.
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), SENATE
Ambulatory Payment Classification (APC) Panel testimony and comments. APC Panel Nomination. Letters to CMS and CMS officials regarding compendia additions and deletions including American Hospital Formulary Service-Drug Information. Comments relating to electronic prescribing under Part D. HR 3025, Medicare Prescription Drug Savings for our Seniors Act of 2007 and S1827, Pharmacist Access and Recognition in Medicare (PhARM) Act of 2007; provisions relating to medication therapy management. HR 3162, Children's Health and Medicare Protection Act (CHAMP Act), provisions on comparative effectiveness research. Recognition of pharmacists as health care providers and payment for clinical services. Recognition of AHFS as drug compendia for coverage of unlabeled uses. Funding for specialized pharmacy residency programs. Electronic prescribing.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), SENATE
Essential use medications and ozone-depleting substances. Nominations to FDA and AHRQ advisory committees,
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE