Medicare Pharmacy Transparency and Fair Auditing Act

Compounding pharmacy issues; drug diversion/cash transactions initiative; Tricare pharmacy copays; H.R. 4215, Medicare Pharmacy Transparency and Fair Auditing Act of 2012

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 4215, Medicare Pharmacy Transparency and Fair Auditing Act of 2012

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 5651, Food and Drug Administration Reform Act of 2012 S. 3187, Food and Drug Administration Safety and Innovation Act H.R. 4215, Medicare Pharmacy Transparency and Fair Auditing Act

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Medicare prescription Part D program Medication adherence Issues related to mail order and pharmacies in Medicare Part D Program. H.R. 4215, Medicare Pharmacy Transparency and Fair Auditing Act

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health reform proposals that impact Medicare Part D such as formulary requirements, PBM disclosure provisions, closing of the Part D coverage gap. General reg/leg Part D issues such as direct negotiation (HR 2190, HR 2248, S 1206) & MTM expansion (HR 891/S 274). Statutory implementation of changes to the definition of AMP in Medicaid. Exclusion of specialty distributors' prompt pay discounts from the definition of Average Sales Price (HR 905/S 733). Medicare audit restrictions (HR 4215)

Client expense: $630,728 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE, White House Office

Issues related to pharmacy benefit managers, particularly H.R. 1971/S. 1058, Pharmacy Competition and Consumer Choice Act of 2011; H.R. 4215, the Medicare Pharmacy Transparency and Fair Auditing Act.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support of HR 4215: Fair audit standards for pharmacy providers in Medicare Part D

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

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

Issues related to H.R.4215, Medicare Pharmacy Transparency and Fair Auditing Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.1560, Nursing Home Resident Pain Relief Act of 2011; issues related to the implementation of the Affordable Care Act (ACA), DEA enforcement of controlled substances in nursing homes and the practice of consultant pharmacy; issues related to PDUFA including Senate amendment on hydrocodone abuse; H.R.4215, Medicare Pharmacy Transparency and Fair Auditing Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

P.L 111-148 - The Affordable Care Act implementation relating to the essential health benefits package, exchange establishment, cost-sharing subsidies and the multi-state plan program; S. 1058 - Pharmacy Competition and Consumer Choice Act; H.R. 4215 - Medicare Pharmacy Transparency and Fair Auditing Act; H.R. 1971 & S. 1058 - Pharmacy Competition and Consumer Choice Act of 2011

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

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

Issues related to Medicare Part D and anti-PBM legislation. Other issues include health care delivery system reforms, cost containment, medication adherence, restrictions on PBM cost saving tools like mail order, generics and restrictions on PBM audit practices. HR 979 - FEHBP Prescription Drug Integrity, Transparency and Cost Savings Act S 1058 Pharmacy Competition and Consumer Choice HR 1971 Pharmacy Competition and Consumer Choice HR 4215-Medicare Pharmacy Transparency & Fair Auditing Act

Client expense: $2,930,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1971/S. 1058 - the "Pharmacy Competition and Consumer Choice Act of 2011," all provisions related to requirement of Pharmacy Benefit Managers annual reporting to Part D plan sponsors of number and total cost of prescriptions under a contract, payments to pharmacies, payments from pharmaceuticals manufacturers and generic and brand name drugs dispensed. H.R. 4215 - the "Medicare Pharmacy Transparency and Fair Auditing Act," amends Medicare Part D to require each contract entered into with a prescription drug plan (PDP) sponsor for the offering of a prescription drug plan to prohibit PDP sponsor from contracting with any pharmacy benefits manager (PBM) to manage the prescription drug coverage under such plan or control the costs of such coverage, unless the manager satisfies specific PBM audit and disclosure requirements. H.R. 6638, the Supporting Access to Formulated and Effective (SAFE) Compounded Drugs Act, all provisions requiring compounding pharmacies to register their facility with the FDA, requiring compounded drugs to be labeled appropriately, establishing an FDA database on compounding pharmacies and having the FDA set minimum production standards. Issues relating to regulations that would establish an effective drug identification and tracking system through which drug manufacturers, repackagers, wholesale distributors and dispensers may authenticate the wholesale distribution history of any prescription drug that is subject to a requirement for a standardized numerical identifier. No specific legislation.

Client expense: $790,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 891, Medication Therapy Management Benefits Act of 2011 S. 44, Medicare Prescription Drug Price Negotiation Act of 2011 S. 274, Medication Therapy Management Empowerment Act of 2011 S. 1356, A Bill to amend title XIX of the Social Security Act to encourage states to increase generic drug utilization under Medicaid H.R. 4215, Medicare Pharmacy Transparency and Fair Auditing Act S. 1251, Medicare and Medicaid FAST Act H.R. 1936, Medicare Access to Diabetes Supplies Act of 2011 H.R. 8, American Taxpayer Relief Act of 2012

Client expense: $440,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), SENATE

S.1058 and H.R. 1971, the Pharmacy Competition and Consumer Choice Act of 2011; H.R. 1936, the Medicare Access to Diabetes Act of 2011; H.R. 1946, the Preserving Our Hometown Independent Pharmacies Act of 2011; S. 1560, Nursing Home Resident Pain Relief Act of 2011; S. 1699, a bill to reduce the costs of prescription drugs under the Medicare program; S. 296, Preserving Access to Life-Savings Medications Act; Drug Cost Reduction Act; S. 2002 and H.R. 4095, Online Pharmacy Safety Act; SEE ADDENDUM S. 1251, Medicare and Medicaid FAST Act; S. 882, STOP Act; S.319, Pharmaceutical Market Access and Drug Safety Act of 2011; S. 1002, SAFE Doses Act; H.R. 4215, The Medicare Pharmacy Transparency and Fair Auditing Act; Prescription Drug User Fee Act; Pharmaceutical Supply Chain Security Drug Shortages legislation; Prescription drug diversion and abuse; TRICARE Pharmacy Benefit/Provisions for inclusion in the National Defense Authorization Act for FY2013; Medicare Part B Revalidation; Hydrocodone Issues; S. 3376, PACT Act, S. 2467 and S. 3254 and H.R. 4310, he National Defense Authorization Act for FY2013; S. 3604, Improving Dementia Care Treatment for Older Adults Act of 2012; Deficit Reduction Issues

Client expense: $320,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), Office of Personnel Management (OPM), SENATE

All legislative and executive actions concerning healthcare reform, including provisions related to medication therapy management (MTM), average manufacturer's price (AMP), durable medical equipment (DME), pharmacy dispensing fees, pharmacy benefit managers, privacy, drug safety, reimportation, increased generic utilization, prescription drug diversion, drug shortages and issues related to compounding pharmacies. S. 274 - The Medication Therapy Management Empowerment Act H.R. 891 - The Medication Therapy Management Benefits Act S. 1058 - Pharmacy Competition and Consumer Choice Act of 2011 H.R. 1971 - Pharmacy Competition and Consumer Choice Act of 2011 S. 3187 - Food and Drug Administration Safety and Innovation Act H.R. 4215 - Medicare Pharmacy Transparency and Fair Auditing Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Medicare Part D and anti-PBM legislation. H.R.979, FEHBP Prescription Drug Integrity, Transparency and Cost Savings Act; S.1058/H.R. 1971, Pharmacy Competition and Consumer Choice; H.R. 4215, Medicare Pharmacy Transparency & Fair Auditing Act.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Insurance Coverage Issues. HR 4215

Client expense: Not reported · Firm income: $45,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1409: All provisions of the Quality Health Care Coalition Act of 2011; H.R. 891/S. 274: All provisions of the Medication Therapy Management Benefits Act of 2011; H.R. 905 /S. 733:All provisions of the legislation to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare; H.R. 979 - All provisions of the FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act H.R. 605 / S. 312 -All provisions of the Patients Freedom to Choose Act S. 27 - All provisions of the Preserve Access to Affordable Generics Act S. 31 - All provisions of the Prescription Drug and Health Improvement Act of 2011 S. 44 -All provisions of the Medicare Prescription Drug Price Negotiation Act of 2011 H.R. 999 / S. 560 - All provisions of the Medicare Prescription Drug Savings and Choice Act of 2011 H.R. 1839 - All provisions of the Community Pharmacy Fairness Act of 2011; H.R. 1946 - All provisions of the Preserving or Hometown Independent Pharmacies Act of 2011; H.R. 1971 / S. 1058 - All provisions of the Pharmacy Competition and Consumer Choice Act of 2011 Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, closing the Part D coverage gap Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, value-based insurance design, e-prescribing, PBM disclosure requirements, and medical loss ratio) Regulatory and proposed legislative changes to Medicare part D including EGWP waivers, MTM expansion, long term care short-term fills, recovery audit contractors Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs FDA issues related to the Prescription Drug User Fee Act (PDUFA) (generic user fees, pedigree, REMs); implementation of approval pathway for generic biologic drugs 340b program H.R. 2672 the Preserving Access to Orphan Drugs Act H.R. 2182 the Generating Antibiotic Incentives Now Act H.R. 3026 the Safeguarding Americas Pharmaceuticals Act H.R. 2746 the Cancer Drug Coverage Parity Act H.R.4215 - All provisions of the Medicare Pharmacy Transparency and Fair Auditing Act

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

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

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

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

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

H.R. 1971/S. 1058 - the "Pharmacy Competition and Consumer Choice Act of 2011," all provisions related to requirement of Pharmacy Benefit Managers annual reporting to Part D plan sponsors of number and total cost of prescriptions under a contract, payments to pharmacies, payments from pharmaceuticals manufacturers and generic and brand name drugs dispensed. H.R. 4215 - the "Medicare Pharmacy Transparency and Fair Auditing Act," amends Medicare Part D to require each contract entered into with a prescripotion drug plan (PDP) sponsor for the offering of a prescription drug plan to prohibit PDP sponsor from contracting with any pharmacy benefits manager (PBM) to manage the prescription drug coverage under such plan or control the costs of such coverage, unless the manager satisfies specific PBM audit and disclosure requirements. H.R. 3026 - the "Safeguarding America's Pharmaceutical Act," all provisions; Requires the Secretary of Health and Human Services (HHS) to issue regulations to establish an effective drug identification and tracking system through which drug manufacturers, repackagers, wholesale distributors, and dispensers may authenticate the wholesale distribution history of any prescription drug that is subject to a requirement for a standardized numerical identifier. Issues relating to regulations that would establish an effective drug identification and tracking system through which drug manufacturers, repackagers, wholesale distributors and dispensers may authenticate the wholesale distribution history of any prescription drug that is subject to a requirement for a standardized numerical identifier. No specific legislation.

Client expense: $320,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Medicare prescription Part D program Medication adherence Issues related to mail order and pharmacies in Medicare Part D Program. H.R. 4215, Medicare Pharmacy Transparency and Fair Auditing Act

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 5651, Food and Drug Administration Reform Act of 2012 S. 3187, Food and Drug Administration Safety and Innovation Act H.R. 4215, Medicare Pharmacy Transparency and Fair Auditing Act

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to pharmacy benefit managers, particularly H.R. 1971/S. 1058, Pharmacy Competition and Consumer Choice Act of 2011; H.R. 4215, the Medicare Pharmacy Transparency and Fair Auditing Act.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Drug diversion/cash transactions initiative; Tricare pharmacy copays; H.R. 4215, Medicare Pharmacy Transparency and Fair Auditing Act of 2012

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 4215, Medicare Pharmacy Transparency and Fair Auditing Act of 2012

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 891, Medication Therapy Management Benefits Act of 2011 S. 44, Medicare Prescription Drug Price Negotiation Act of 2011 S. 274, Medication Therapy Management Empowerment Act of 2011 S. 1356, A Bill to amend title XIX of the Social Security Act to encourage states to increase generic drug utilization under Medicaid H.R. 4215, Medicare Pharmacy Transparency and Fair Auditing Act S. 1251, Medicare and Medicaid FAST Act H.R. 1936, Medicare Access to Diabetes Supplies Act of 2011

Client expense: $440,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), SENATE

Health reform proposals that impact Medicare Part D such as formulary requirements, PBM disclosure provisions, closing of the Part D coverage gap. General reg/leg Part D issues such as direct negotiation (HR 2190, HR 2248, S 1206) & MTM expansion (HR 891/S 274). Statutory implementation of changes to the definition of AMP in Medicaid. Exclusion of specialty distributors' prompt pay discounts from the definition of Average Sales Price (HR 905/S 733). Medicare audit restrictions (HR 4215)

Client expense: $423,292 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE, White House Office

Issues related to the corporate business model, Medicare Part D and anti-PBM legislation. Other issues include health care delivery system reforms, cost containment, medication adherence, restrictions on PBM cost saving tools like mail order, generics and restrictions on PBM audit practices. H.R.979, FEHBP Prescription Drug Integrity, Transparency and Cost Savings Act; S.1058/H.R. 1971, Pharmacy Competition and Consumer Choice; H.R. 4215, Medicare Pharmacy Transparency & Fair Auditing Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

HR 4215: Support legislation relating to standardized audit standards for pharmacies with Medicare drug benefit sponsors

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Medicare Part D and anti-PBM legislation. Other issues include health care delivery system reforms, cost containment, medication adherence, restrictions on PBM cost saving tools like mail order, generics and restrictions on PBM audit practices. HR 979 - FEHBP Prescription Drug Integrity, Transparency and Cost Savings Act S 1058 Pharmacy Competition and Consumer Choice HR 1971 Pharmacy Competition and Consumer Choice HR 4215-Medicare Pharmacy Transparency & Fair Auditing Act

Client expense: $2,320,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

S.1560, Nursing Home Resident Pain Relief Act of 2011; issues related to the implementation of the Affordable Care Act (ACA), DEA enforcement of controlled substances in nursing homes and the practice of consultant pharmacy; issues related to PDUFA including Senate amendment on hydrocodone abuse; H.R.4215, Medicare Pharmacy Transparency and Fair Auditing Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

All legislative and executive actions concerning healthcare reform, including provisions related to medication therapy management (MTM), average manufacturer's price (AMP), durable medical equipment (DME), pharmacy dispensing fees, pharmacy benefit managers, privacy, drug safety, reimportation, increased generic utilization, and prescription drug diversion. Proposed merger of Medco Health Solutions and Express Scripts, Inc. S. 274 - The Medication Therapy Management Empowerment Act H.R. 891 - The Medication Therapy Management Benefits Act S. 1058 - Pharmacy Competition and Consumer Choice Act of 2011 H.R. 1971 - Pharmacy Competition and Consumer Choice Act of 2011 S. 3187 - Food and Drug Administration Safety and Innovation Act H.R. 4215 - Medicare Pharmacy Transparency and Fair Auditing Act

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

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

P.L 111-148 - The Affordable Care Act relating to the essential health benefits package and exchange establishment; S. 1058 - Pharmacy Competition and Consumer Choice Act; H.R. 4215 - Medicare Pharmacy Transparency and Fair Auditing Act; H.R. 5651 & S. 2516 & S. 3187 FDA Safety and Innovation Act; H.R. 1971 & S. 1058 - Pharmacy Competition and Consumer Choice Act of 2011

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

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

S. 1058 and H.R. 1971, the Pharmacy Competition and Consumer Choice Act of 2011; H.R. 1936, the Medicare Access to Diabetes Act of 2011; H.R. 1946, the Preserving Our Hometown Independent Pharmacies Act of 2011; S. 1560, Nursing Home Resident Pain Relief Act of 2011; S. 1699, a bill to reduce the costs of prescription drugs under the Medicare program; SEE ADDENDUM S. 296, Preserving Access to Life-Savings Medications Act; Drug Cost Reduction Act; S. 2002 and H.R. 4095, Online Pharmacy Safety Act; S. 1251, Medicare and Medicaid FAST Act; S. 882, STOP Act; S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011; S. 1002, SAFE Doses Act; H.R. 4215, The Medicare Pharmacy Transparency and Fair Auditing Act; Prescription Drug User Fee Act; Pharmaceutical Supply Chain Security; Drug Shortages legislation; Prescription drug diversion and abuse; TRICARE Pharmacy Benefit/Provisions for inclusion in National Defense Authorization Act for FY2013; Medicare Part B Revalidation; Hydrocodone Issues; S. 3376, PACT Act, S. 2467 and S. 3254 and H.R. 4310, the National Defense Authorization Act for Fiscal Year 2013; S. 3604, Improving Dementia Care Treatment for Older Adults Act of 2012;

Client expense: $300,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), Office of Personnel Management (OPM), SENATE

Prime Specialty Pharmacy Facility Opening H.R. 4215 Medicare Pharmacy Transparency and Fair Auditing Act H.R. 1971 Pharmacy Competition and Consumer Choice Act of 2011 S. 1058 Pharmacy Competition and Consumer Choice Act of 2011

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Specialty pharmacy facility opening H.R. 4215: Medicare Pharmacy Transparency and Fair Auditing Act H.R. 1971: Pharmacy Competition and Consumer Choice Act of 2011 S. 1058: Pharmacy Competition and Consumer Choice Act of 2011

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1971/S. 1058 - the "Pharmacy Competition and Consumer Choice Act of 2011," all provisions related to requirement of Pharmacy Benefit Managers annual reporting of number and total cost of prescriptions under a contract, payments to pharmacies, payments from pharmaceuticals manufacturers and generic and brand name drugs dispensed. H.R. 3026 - the "Safeguarding America's Pharmaceutical Act," all provisions; Requires the Secretary of Health and Human Services (HHS) to issue regulations to establish an effective drug identification and tracking system through which drug manufacturers, repackagers, wholesale distributors, and dispensers may authenticate the wholesale distribution history of any prescription drug that is subject to a requirement for a standardized numerical identifier. H.R. 4095 - the "Online Pharmacy Safety Act," all provisions regarding requiring the U.S. Department of Health and Human Services (HHS) to create a public registry of legitimate online pharmacy websites. H.R. 4215 - the "Medicare Pharmacy Transparency and Fair Auditing Act," amends Medicare Part D to require each contract entered into with a prescripotion drug plan (PDP) sponsor for the offering of a prescription drug plan to prohibit the PDP sponsor from contracting with any pharmacy benefits manager (PBM) to manage the prescription drug coverage under such plan, or to control the costs of such coverage, unless the manager satisfies specified PBM audit and disclosure requirements. S. 1584 - the "Drug Safety and Accountability Act," all provisions; Authorizes the Secretary of Health and Human Services (HHS) to order an establishment to promptly revise its quality management plan in response to a significant threat to public health and requires each registered drug producer to report on each producer, manufacturer, distributor, and shipper involved in the production of a drug or the production or transport of the active ingredients of a drug. Requires the Secretary to develop and maintain information systems to track and assess every establishment that is involved in the manufacturing, preparation, propagation, compounding, or processing of a drug or active ingredient of a drug.

Client expense: $540,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Medicare Part D and anti-PBM legislation. Other issues include health care delivery system reforms, cost containment, medication adherence, restrictions on PBM cost saving tools like mail order, generics and restrictions on PBM audit practices. HR 979 - FEHBP Prescription Drug Integrity, Transparency and Cost Savings Act S 1058 Pharmacy Competition and Consumer Choice HR 1971 Pharmacy Competition and Consumer Choice HR 4215-Medicare Pharmacy Transparency & Fair Auditing Act

Client expense: $2,255,000 · Firm income: Not reported

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

Issues related to pharmacy benefit managers, particularly H.R. 1971/S. 1058, Pharmacy Competition and Consumer Choice Act of 2011; H.R. 4215, the Medicare Pharmacy Transparency and Fair Auditing Act.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 891, Medication Therapy Management Benefits Act of 2011 S. 44, Medicare Prescription Drug Price Negotiation Act of 2011 S. 274, Medication Therapy Management Empowerment Act of 2011 S. 1356, A Bill to amend title XIX of the Social Security Act to encourage states to increase generic drug utilization under Medicaid H.R. 4215, Medicare Pharmacy Transparency and Fair Auditing Act S. 1251, Medicare and Medicaid FAST Act H.R. 1936, Medicare Access to Diabetes Supplies Act of 2011

Client expense: $560,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), SENATE

S.1560, Nursing Home Resident Pain Relief Act of 2011; issues related to the implementation of the Affordable Care Act (ACA), DEA enforcement of controlled substances in nursing homes and the practice of consultant pharmacy; issues related to PDUFA including Senate amendment on hydrocodone abuse; H.R.4215, Medicare Pharmacy Transparency and Fair Auditing Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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