Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page

9. Check if this filing amends a previously filed version of this report

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code HCR

16. Specific lobbying issues

HR 2751 - FDA Food Safety Modernization Act (Sections on dietary supplements, establishment of foreign FDA offices; and the establishment of voluntary food allergy and anaphylaxis management guidelines)
Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) and the Institute of Medicine of National Academies
HR 1259 - Dextromethorphan Distribution Act of 2009
HR 2891 - Access to Frontline Health Care Act of 2009
HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices

(Public Law 111-152) Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.]

(Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demonstration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program (ACOs); national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); improvements to the Medicare Part D MTM programs; exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MA-PD plans; improving formulary requirements for prescription drug plans and MA-PD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MA-PD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MA-PD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal...
medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); Medicare vaccine coverage issues (Medicare Part B vs. Part D); and funding for the grant program established in the section on medication management (MTM) services in treatment of chronic disease).]

(26 CFR Part 54/ 29 CFR Part 2590/ 45 CFR Parts 146 and 148) Medical Loss Ratios; Request for Comments Regarding Section 2718 of the Public Health Service Act
(RIN 0950-AA06) Health Insurance Issuers Implementing Medical Loss Ratio (MLR) Requirements Under the Patient Protection and Affordable Care Act; Interim Final Rule
(Docket Number: 75FR65495) National Institutes for Health; Interagency Pain Research Coordinating Committee; Call for Nominations
(Docket Number: 2010-28041) Solicitation for Nominations for Members of the U.S. Preventive Services Task Force
(Docket Number: CMS-0009-N) Health Insurance Reform; Announcement of Maintenance Changes to Electronic Data Transaction Standards Adopted Under the Health Insurance Portability and Accountability Act of 1996
(Docket Number: OCIIO-9992-IFC) Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient Protection and Affordable Care Act
(Docket Number: 75FR65359)AHRQ Common Formats for Patient Safety Data Collection and Event Reporting; Notice of availability

NAIC Regulation for Uniform Definitions and Standardized Rebate Calculation Methodology for Plan Years 2011, 2012 and 2013 per Section 2718 (b) of the Health Service Act
HHS Request for Comment on the Development of the National Health Care Quality Strategy and Plan
IRS Notice (2010-59) on: Section 105 - Amounts Received under Accident and Health Plans, Section 106 Contributions by
Employers to Accident and Health Plans, Section 125 - Cafeteria Plans, Section 220 Archer MSAs, Section 223 Health Savings Accounts (P.L. 111-148, Section 9003)
IRS Revised Notice (2011-5) on: Section 105 - Amounts Received under Accident and Health Plans, Section 106
Contributions by Employers to Accident and Health Plans, Section 125 Cafeteria Plans (P.L. 111-148, Section 9003)
HHS National Health Care Quality Strategy and Plan
IOM Study on the Determination of Essential Health Benefits in P.L. 111-148

Concept Opportunities for Pharmacist Clinical Services in Health Care Reform Provisions

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Health & Human Services - Dept of (HHS), Food & Drug Administration (FDA), Centers For Medicare and Medicaid Services (CMS), Natl Institutes of Health (NIH), Internal Revenue Service (IRS)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code BUD

16. Specific lobbying issues

(Public Law 111-148) Patient Protection and Affordable Care Act - Appropriations for the MTM Grant Program and for Programs to Establish Integrated and Coordinated Care Models

Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ)

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Centers For Medicare and Medicaid Services (CMS), Health & Human Services - Dept of (HHS)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code PHA

16. Specific lobbying issues

S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2010
S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010
HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009
Under Line 17: We would like to include the Office of National Drug Control Policy (ONDCP)
HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010
HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program
HR 1204 - The Community Pharmacy Fairness Act of 2009
S 754 - The Methadone Treatment and Protection Act of 2009
HR 2855 - The Drug Overdose Reduction Act
HR 163 - Prescription Drug Affordability Act
S 80 - Pharmaceutical Market Access Act of 2009
HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps

(Docket Number: FDA-2010-N-0001) Third Annual Sentinel Initiative Public Workshop
(Docket Number: FDA-2010-N-0128) Prescription Drug User Fee Act; Reopening of the Comment Period
(Docket Number: FRL-9197-7) EPA Best Management Practices for Unused Pharmaceuticals at Health Care Facilities
(Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings
(Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period
(Docket Number: DEA-338) Schedules of Controlled Substances: Placement of Propofol Into Schedule IV; Proposed Rule
(Docket Number: FDA-2010-N-0273) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Quality System Regulations
(Docket No. FDA-2010-N-0344) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products
(Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing
(Docket Number: FDA-2010-N-0477) Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request for Comments
(Docket Number: FDA2010N0486) Safe Use Initiative; Public Workshop; Request for Comments
(RIN 0720AB45) DoD Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/ TRICARE: Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of Pharmaceuticals
(Docket Number: DEA316N) Procedures for the Surrender of Unwanted Controlled Substances by Ultimate Users; Notice of Meeting
(Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information
(Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies

FDA Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information

Concept Standardizing REMS programs, components and development of a potential tiered REMS System
Concept 2010 National Drug Control Strategy (ONDCP)

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Food & Drug Administration (FDA), White House Office, Health & Human Services - Dept of (HHS), Environmental Protection Agency (EPA), Defense - Dept of (DOD), Drug Enforcement Administration (DEA)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code MMM

16. Specific lobbying issues

S 3543 - Medication Therapy Management Expanded Benefits Act of 2010
HR 3108 - Medication Therapy Management Benefits Act of 2009
Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC)
HR 5389 - Medicare Clinical Pharmacist Practitioner Services Coverage Act of 2010
HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act

(Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on long-term care pharmacy waste reduction programs, fraud, waste and abuse provisions, the Medicare durable medical equipment, prosthetics, orthotics, supplies (DMEPOS) accreditation requirements, the CMS Innovation Center, and pharmacists participation in Accountable Care Organizations (ACOs) and other integrated care models such as the Independence at Home demonstration program]

(Docket Number: CMS-4144-P) Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2012 and Other Proposed Changes; Proposed Rule
(Docket Number: CMS-1345-NC) Medicare Program: Request for Information Regarding Accountable Care Organizations and the Shared Savings Program
(Docket Number: CMS1503FC) Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2011; Final Rule
(Docket Number: CMS-6034-P) Medicaid Program; Recovery Audit Contractors
(Docket Number: CMS5055N) Medicare Program: Community-Based Care Transitions Program (CCTP) Meeting
(Docket Number: CMS-2238-P2) Medicaid Program; Withdrawal of Determination of Average Manufacturer Price, Multiple Source Drug Definition, and Upper Limits for Multiple Source Drugs
(RIN 0991-AB58) ONC Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Final Rule
(RIN 0991-AB76) ONC Health Information Technology: Revisions to Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology
(Docket Number: CMS-0033-F) Medicare and Medicaid Programs; Electronic Health Record Incentive Program
(Docket Number: FDA-2010-N-0308) Parallel Review of Medical Products
(Docket Number: CMS-6028-P) Medicare, Medicaid, and Children's Health Insurance Programs; Additional Screening Requirements, Application Fees, Temporary Enrollment Moratoria, Payment Suspensions and Compliance Plans for Providers and Suppliers
(Docket Number: CMS6010IFC) Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements

CMS Announcement of Calendar Year (CY) 2011: Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter
CMS Changes to CMS True-Out-Of-Pocket Facilitator for Medicare Part D
CMS 2011 Non-Matched NDC List
CMS Medicare Part D Coverage Gap Discount Program

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Centers For Medicare and Medicaid Services (CMS), Health & Human Services - Dept of (HHS), Food & Drug Administration (FDA)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

Information Update Page - Complete ONLY where registration information has changed.

20. Client new address

21. Client new principal place of business (if different than line 20)

22. New General description of client’s business or activities

LOBBYIST UPDATE

23. Name of each previously reported individual who is no longer expected to act as a lobbyist for the client

ISSUE UPDATE

24. General lobbying issue that no longer pertains

AFFILIATED ORGANIZATIONS

25. Add the following affiliated organization(s)

Internet Address:

26. Name of each previously reported organization that is no longer affiliated with the registrant or client

FOREIGN ENTITIES

27. Add the following foreign entities:

28. Name of each previously reported foreign entity that no longer owns, or controls, or is affiliated with the registrant, client or affiliated organization