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Modernizing Laboratory Test Standards for Patients Act of 2011
Legislative Progress
Introduced
October 14, 2011
Latest Action
October 14, 2011
Primary Sponsor
Michael C. BurgessRepublican(TX)
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
0pct
0d open
vs 6,662 other HR bills in the 112th — cohort avg 39d
No CRS summary is available for this bill yet. The source title, actions, sponsors, and text versions below come from Congress.gov.
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Filing registrants (30)
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Sources: Congress.gov
2013 · second_quarter · Medicare/Medicaid
Patient Protection and Affordable Care Act (PPACA) implementation issues, HR 2461- The Physician Pathology Continuity Act, HR 3207-Modernizing Lab Test Standards for Patients Act of 2011, Budget Control Act of 2011, Sustainable Growth Rate reform, Fee schedule placement of genomic and genetic tests, Proposed CY2012 Medicare Physician Fee Schedule Rule (CMS-1590-P).Medicare funding and beneficiary cost-sharing for Clinical Lab Fee Schedule in HR 3630-The Middle Class Tax Relief & Job Creation Act of 2012 and HR 3765-The Temporary Payroll Tax Cut Continuation Act of 2011, and Medicare Clinical Laboratory Fee Schedule reimbursement issues including pricing for and coverage of molecular diagnostic tests.
Client expense: $86,350 · 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), SENATE
2013 · second_quarter · Medical/Disease Research/Clinical Labs
Patient Protection and Affordable Care Act (PPACA) implementation issues, HR 2461- The Physician Pathology Continuity Act, HR 3207-Modernizing Lab Test Standards for Patients Act of 2011, Budget Control Act of 2011, Sustainable Growth Rate reform, Fee schedule placement of genomic and genetic tests, Proposed CY2012 Medicare Physician Fee Schedule Rule (CMS-1590-P).Medicare funding and beneficiary cost-sharing for Clinical Lab Fee Schedule in HR 3630-The Middle Class Tax Relief & Job Creation Act of 2012 and HR 3765-The Temporary Payroll Tax Cut Continuation Act of 2011, and Medicare Clinical Laboratory Fee Schedule reimbursement issues including pricing for and coverage of molecular diagnostic tests.
Client expense: $86,350 · 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), SENATE
2013 · second_quarter · Health Issues
Patient Protection and Affordable Care Act (PPACA) implementation issues, HR 2461- The Physician Pathology Continuity Act, HR 3207-Modernizing Lab Test Standards for Patients Act of 2011, Budget Control Act of 2011, Sustainable Growth Rate reform, Fee schedule placement of genomic and genetic tests, Proposed CY2012 Medicare Physician Fee Schedule Rule (CMS-1590-P).Medicare funding and beneficiary cost-sharing for Clinical Lab Fee Schedule in HR 3630-The Middle Class Tax Relief & Job Creation Act of 2012 and HR 3765-The Temporary Payroll Tax Cut Continuation Act of 2011, and Medicare Clinical Laboratory Fee Schedule reimbursement issues including pricing for and coverage of molecular diagnostic tests.
Client expense: $86,350 · 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), SENATE
2013 · second_quarter · Insurance
Patient Protection and Affordable Care Act (PPACA) implementation issues, HR 2461- The Physician Pathology Continuity Act, HR 3207-Modernizing Lab Test Standards for Patients Act of 2011, Budget Control Act of 2011, Sustainable Growth Rate reform, Fee schedule placement of genomic and genetic tests, Proposed CY2012 Medicare Physician Fee Schedule Rule (CMS-1590-P).Medicare funding and beneficiary cost-sharing for Clinical Lab Fee Schedule in HR 3630-The Middle Class Tax Relief & Job Creation Act of 2012 and HR 3765-The Temporary Payroll Tax Cut Continuation Act of 2011, and Medicare Clinical Laboratory Fee Schedule reimbursement issues including pricing for and coverage of molecular diagnostic tests.
Client expense: $86,350 · 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), SENATE
2013 · first_quarter · Health Issues
Patient Protection and Affordable Care Act (PPACA) implementation issues, HR 2461- The Physician Pathology Continuity Act, HR 3207-Modernizing Lab Test Standards for Patients Act of 2011, Budget Control Act of 2011, Sustainable Growth Rate reform, Fee schedule placement of genomic and genetic tests, Proposed CY2012 Medicare Physician Fee Schedule Rule (CMS-1590-P).Medicare funding and beneficiary cost-sharing for Clinical Lab Fee Schedule in HR 3630-The Middle Class Tax Relief & Job Creation Act of 2012 and HR 3765-The Temporary Payroll Tax Cut Continuation Act of 2011.
Client expense: $113,052 · 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), SENATE
| Republican |
| WA |
| Cliff Stearns | Republican | FL |
| David B. McKinley | Republican | WV |
| Erik Paulsen | Republican | MN |
| H. Morgan Griffith | Republican | VA |
| Howard Coble | Republican | NC |
| John Abney Culberson | Republican | TX |
| Kevin Yoder | Republican | KS |
| Leonard Lance | Republican | NJ |
| Marsha Blackburn | Republican | TN |
| Patrick J. Tiberi | Republican | OH |
| Patrick Meehan | Republican | PA |
| Pete Sessions | Republican | TX |
| Robert E. Latta | Republican | OH |
| Tim Murphy | Republican | PA |
2013 · first_quarter · Medical/Disease Research/Clinical Labs
Patient Protection and Affordable Care Act (PPACA) implementation issues, HR 2461- The Physician Pathology Continuity Act, HR 3207-Modernizing Lab Test Standards for Patients Act of 2011, Budget Control Act of 2011, Sustainable Growth Rate reform, Fee schedule placement of genomic and genetic tests, Proposed CY2012 Medicare Physician Fee Schedule Rule (CMS-1590-P).Medicare funding and beneficiary cost-sharing for Clinical Lab Fee Schedule in HR 3630-The Middle Class Tax Relief & Job Creation Act of 2012 and HR 3765-The Temporary Payroll Tax Cut Continuation Act of 2011.
Client expense: $113,052 · 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), SENATE
2013 · first_quarter · Medicare/Medicaid
Patient Protection and Affordable Care Act (PPACA) implementation issues, HR 2461- The Physician Pathology Continuity Act, HR 3207-Modernizing Lab Test Standards for Patients Act of 2011, Budget Control Act of 2011, Sustainable Growth Rate reform, Fee schedule placement of genomic and genetic tests, Proposed CY2012 Medicare Physician Fee Schedule Rule (CMS-1590-P).Medicare funding and beneficiary cost-sharing for Clinical Lab Fee Schedule in HR 3630-The Middle Class Tax Relief & Job Creation Act of 2012 and HR 3765-The Temporary Payroll Tax Cut Continuation Act of 2011.
Client expense: $113,052 · 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), SENATE
2013 · first_quarter · Insurance
Patient Protection and Affordable Care Act (PPACA) implementation issues, HR 2461- The Physician Pathology Continuity Act, HR 3207-Modernizing Lab Test Standards for Patients Act of 2011, Budget Control Act of 2011, Sustainable Growth Rate reform, Fee schedule placement of genomic and genetic tests, Proposed CY2012 Medicare Physician Fee Schedule Rule (CMS-1590-P).Medicare funding and beneficiary cost-sharing for Clinical Lab Fee Schedule in HR 3630-The Middle Class Tax Relief & Job Creation Act of 2012 and HR 3765-The Temporary Payroll Tax Cut Continuation Act of 2011.
Client expense: $113,052 · 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), SENATE
2012 · first_quarter · Health Issues
Health reform law implementation issues including application of the medical device tax to laboratory tests and the Clinical Laboratory Fee Schedule; the oversight of laboratory-developed tests, H.R. 3207, the Modernizing Laboratory Tests Standards for Patients Act of 2011; the Budget Control Act of 2011 (P.L. 112-225);in-office ancillary services exception to Stark law; H.R. 3060, the Middle Class Tax Relief and Job Creation Act of 2012 (P.L. 112-96).
Client expense: $192,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2012 · fourth_quarter · Medical/Disease Research/Clinical Labs
FDA draft guidance to regulate laboratory developed tests Legislation to regulate clinical labs (HR 3207, Modernizing Laboratory Test Standards for Patients Act of 2011); full bill
Client expense: $150,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2012 · fourth_quarter · Health Issues
Health reform law implementation issues including application of the medical device tax to clinical laboratories; in office ancillary services exemption to the Stark law; H.R. 3207, the Modernizing Laboratory Test Standards Act for Patients Act; H.R. 6118/S. 3391, the Taking Essential Steps for Testing Act; the coding, pricing, and placement of molecular pathology laboratory tests; Medicare Clinical Laboratory Fee Schedule reimbursement levels; H.R. 8, the American Taxpayer Relief Act of 2012
Client expense: $200,677 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), President of the U.S., SENATE
2012 · fourth_quarter · Medicare/Medicaid
Health reform law implementation issues including application of the medical device tax to clinical laboratories; in office ancillary services exemption to the Stark law; H.R. 3207, the Modernizing Laboratory Test Standards Act for Patients Act; H.R. 6118/S. 3391, the Taking Essential Steps for Testing Act; the coding, pricing, and placement of molecular pathology laboratory tests; Medicare Clinical Laboratory Fee Schedule reimbursement levels; H.R. 8, the American Taxpayer Relief Act of 2012
Client expense: $200,677 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), President of the U.S., SENATE
2012 · fourth_quarter · Health Issues
Patient Protection and Affordable Care Act implementation. S. 99, American Medical Isotopes Production Act of 2011; issues related to nuclear medicine. FDA approval process/510(k). Medical device tax. H.R. 3209, Premarket Predictability Act. H.R. 3203 / S. 1943, Novel Device Regulatory Relief Act. H.R. 3230, Keeping America Competitive through Harmonization Act. H.R. 3205, FDA Renewing Efficiency from Outside Review Management Act. H.R. 3211, Humanitarian Device Reform Act. H.R. 3208, Patients Come First Act. H.R. 3206, Cultivating Scientific Experts to Foster Innovation Act. H.R. 3214, Food and Drug Administration Mission Reform Act. H.R. 3207, Modernizing Laboratory Test Standards for Patients Act. H.R. 3204, Guidance Accountability and Transparency Act. S. 1700, The Medical Device Regulatory Improvement Act. S. 1865, The Patient Access to Medical Innovation Act. S. 1972, A bill to amend the Food and Drug Administrations mission. S. 1995, A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. CMS coverage for transcutaneous electrical nerve stimulation for lower back pain
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2012 · fourth_quarter · Health Issues
Healthcare issues related to clinical laboratories; FDA oversight of laboratory developed tests and related legislation (H.R. 3207); Medicare reimbursement levels for laboratory services
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2012 · fourth_quarter · Medical/Disease Research/Clinical Labs
FDA draft guidance to regulate laboratory developed tests Legislation to regulate clinical labs (HR 3207, Modernizing Laboratory Test Standards for Patients Act of 2011); full bill
Client expense: $100,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2012 · fourth_quarter · Health Issues
- Issues related to ensuring quality of supply chain for FDA regulated products. - Issues related to Accountable Care Organizations. - Issues related to Physician Payment Sunshine provisions. - Issues related to the "Regulation & Reimbursement of Diagnostics", regarding all provisions. - Implementation of the Health Care Reform Bill, regarding Medicare wellness benefit. - Issues related to maintaining the biosimilars statute without changes. - HR 2960, "National Diabetes Clinical Care Commission Act", regarding all provisions. - HR 3026, "Safeguarding America's Pharmaceutical Act of 2011", regarding all provisions. - Prescription Drug User Fee Act, regarding all provisions - Personalized Medicine Incentives and Regulation. - Issues related to Alzheimer's research. - HR 2939, "Pharmaceutical Stewardship Act of 2011", regarding all provisions. - HR 3497, "MODERN Cures Act of 2011", regarding all provisions. - HR 3207, "Modernizing Laboratory Test Standards for Patients Act of 2011", regarding all provisions. - S 1700, "Medical Device Regulatory Improvement Act", regarding all provisions. - S 1865, "Patient Access to Medical Innovation Act", regarding all provisions. - S 1995, "Medical Device Patient Safety Act", regarding all provisions. - Issues related to vision care coverage under PPACA. - Medical Device User Fee Act Reauthorization. - HR 1483, "The Drug Safety Enhancement Act of 2011", regarding all provisions. - HR 3847, "Safety of Untested and New Devices Act of 2012", regarding all provisions. - HR 3975, "A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007", regarding all provisions. - S 2113, "A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve public health." regarding all provisions. - S 2193, "Ensuring Safe Medical Devices for Patients", regarding all provisions. - HR 5, "Protecting Access to Healthcare (PATH) Act", regarding all provisions. - HR 452, "Medicare Decisions Accountability Act of 2011", regarding all provisions. - Issues related to the repeal and/or reform of Independent Payment Advisory Boards. - HR 5937, "Breast Cancer Patient Education Act of 2012", regarding all provisions. - HR 5998, "USPSTF Transparency and Accountability Act of 2012", regarding all provisions. - S 3187, "Food and Drug Administration Safety and Innovation Act", regarding all provisions. - S 2516, "Food and Drug Administration Safety and Innovation Act", regarding all provisions. - HR 6584, Verifying Authority and Legality In Drug Compounding Act of 2012, regarding all provisions.
Client expense: $880,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2012 · fourth_quarter · Health Issues
Patient Protection and Affordable Care Act (PPACA) implementation issues, HR 2461- The Physician Pathology Continuity Act, HR 3207-Modernizing Lab Test Standards for Patients Act of 2011, Budget Control Act of 2011, Sustainable Growth Rate reform, Fee schedule placement of genomic and genetic tests, Proposed CY2012 Medicare Physician Fee Schedule Rule (CMS-1590-P). Medicare funding and beneficiary cost-sharing for Clinical Lab Fee Schedule in HR 3630-The Middle Class Tax Relief & Job Creation Act of 2012 and HR 3765-The Temporary Payroll Tax Cut Continuation Act of 2011.
Client expense: $52,827 · 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), SENATE
2012 · fourth_quarter · Medical/Disease Research/Clinical Labs
Patient Protection and Affordable Care Act (PPACA) implementation issues, HR 2461- The Physician Pathology Continuity Act, HR 3207-Modernizing Lab Test Standards for Patients Act of 2011, Budget Control Act of 2011, Sustainable Growth Rate reform, Fee schedule placement of genomic and genetic tests, Proposed CY2012 Medicare Physician Fee Schedule Rule (CMS-1590-P). Medicare funding and beneficiary cost-sharing for Clinical Lab Fee Schedule in HR 3630-The Middle Class Tax Relief & Job Creation Act of 2012 and HR 3765-The Temporary Payroll Tax Cut Continuation Act of 2011.
Client expense: $52,827 · 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), SENATE
2012 · fourth_quarter · Insurance
Patient Protection and Affordable Care Act (PPACA) implementation issues, HR 2461- The Physician Pathology Continuity Act, HR 3207-Modernizing Lab Test Standards for Patients Act of 2011, Budget Control Act of 2011, Sustainable Growth Rate reform, Fee schedule placement of genomic and genetic tests, Proposed CY2012 Medicare Physician Fee Schedule Rule (CMS-1590-P). Medicare funding and beneficiary cost-sharing for Clinical Lab Fee Schedule in HR 3630-The Middle Class Tax Relief & Job Creation Act of 2012 and HR 3765-The Temporary Payroll Tax Cut Continuation Act of 2011.
Client expense: $52,827 · 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), SENATE
2012 · fourth_quarter · Medicare/Medicaid
Patient Protection and Affordable Care Act (PPACA) implementation issues, HR 2461- The Physician Pathology Continuity Act, HR 3207-Modernizing Lab Test Standards for Patients Act of 2011, Budget Control Act of 2011, Sustainable Growth Rate reform, Fee schedule placement of genomic and genetic tests, Proposed CY2012 Medicare Physician Fee Schedule Rule (CMS-1590-P). Medicare funding and beneficiary cost-sharing for Clinical Lab Fee Schedule in HR 3630-The Middle Class Tax Relief & Job Creation Act of 2012 and HR 3765-The Temporary Payroll Tax Cut Continuation Act of 2011.
Client expense: $52,827 · 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), SENATE
2012 · fourth_quarter · Health Issues
HR 8, American Taxpayer Relief Act of 2012, all sections relating to vision. HR 353, Glaucoma Screening Act of 2011., all sections relating to vision. HR 451, Healthcare Truth and Transparency Act of 2011, all sections relating to vision. HR 452, Medicare Decisions Accountability Act of 2011, all sections relating to vision. HR 531, Access to Frontline Health Care Act of 2011, all sections relating to vision. HR 605, Patients Freedom to Choose Act, all sections relating to vision. HR 969, Medical Practice Freedom Act of 2011, all sections relating to vision. HR 1195, National Health Service Corps Improvement Act of 2011, all sections relating to vision. HR 1206, Access to Professional Health Insurance Advisors Act of 2011, all sections relating to vision. HR 3183, To amend title XXVII of the Public Health Service Act to exempt licensed independent insurance producer remuneration from the medical loss ratio, all sections relating to vision. HR 3207, Modernizing Laboratory Test Standards for Patients Act of 2011, all sections relating to vision. S 312, Patients Freedom to Choose Act, all sections relating to vision. S 2068, Access to Independent Health Insurance Advisors Act of 2012, all sections relating to vision. S 2192, National Health Service Corps Improvement Act of 2012, all sections relating to vision. S 2297, A bill to amend the Controlled Substances Act to make any substance containing hydrocodone a schedule II drug, all sections relating to vision.
Client expense: $329,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2012 · fourth_quarter · Consumer Issues/Safety/Products
HR 451, Healthcare Truth and Transparency Act of 2011, all sections relating to vision. HR 605, Patients Freedom to Choose Act, all sections relating to vision. HR 3207, Modernizing Laboratory Test Standards for Patients Act of 2011, all sections relating to vision. S 312, Patients Freedom to Choose Act, all sections relating to vision. S 2297, A bill to amend the Controlled Substances Act to make any substance containing hydrocodone a schedule II drug, all sections relating to vision.
Client expense: $329,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2012 · fourth_quarter · Medical/Disease Research/Clinical Labs
Healthcare Reform Legislation and its impact on clinical laboratories and laboratory personnel; FDA initiatives to regulate laboratory-developed diagnostic tests; legislation concerning regulation of laboratory-developed diagnostic tests (including H.R. 3207); support Taking Essential Steps for Testing Act (H.R. 6118; S.3391).
Client expense: Not reported · Firm income: $10,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2012 · fourth_quarter · Health Issues
**see addendum page PL 111-148 - The Patient Protection and Affordable Care Act, implementation PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 3207 - Modernizing Laboratory Test Standards for Patients Act ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics
Client expense: Not reported · Firm income: $70,000
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2012 · fourth_quarter · Medical/Disease Research/Clinical Labs
Draft guidance regarding Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions; Provisions regarding FDA regulation of certain diagnostics. H.R. 3207: Modernizing Laboratory Test Standards for Patients Act of 2011; Provisions regarding lab developed tests. Draft regulation regarding Unique Device Identification System: Provisions regarding FDA requirements for medical device labeling.
Client expense: $150,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2012 · fourth_quarter · Health Issues
**see addendum page PL 111-148 - The Patient Protection and Affordable Care Act, implementation PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 3207 - Modernizing Laboratory Test Standards for Patients Act ***, no specific bills, FDA related issues, diagnostics, drug shortages
Client expense: Not reported · Firm income: $60,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2012 · fourth_quarter · Health Issues
**see addendum page PL 111-148 - The Patient Protection and Affordable Care Act, implementation PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 3207 - Modernizing Laboratory Test Standards for Patients Act ***, no specific bill(s), 510k reform, imaging policy, medical device user fee reauthorization and all related policies
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2012 · fourth_quarter · Medicare/Medicaid
Health reform law implementation issues including application of the medical device tax to clinical laboratories; in office ancillary services exemption to the Stark law; H.R. 3207, the Modernizing Laboratory Test Standards Act for Patients Act; H.R. 6118/S. 3391, the Taking Essential Steps for Testing Act; the coding, pricing, and placement of molecular pathology laboratory tests; Medicare Clinical Laboratory Fee Schedule reimbursement levels; H.R. 8, the American Taxpayer Relief Act of 2012
Client expense: $200,677 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), President of the U.S., SENATE
2012 · fourth_quarter · Health Issues
Health reform law implementation issues including application of the medical device tax to clinical laboratories; in office ancillary services exemption to the Stark law; H.R. 3207, the Modernizing Laboratory Test Standards Act for Patients Act; H.R. 6118/S. 3391, the Taking Essential Steps for Testing Act; the coding, pricing, and placement of molecular pathology laboratory tests; Medicare Clinical Laboratory Fee Schedule reimbursement levels; H.R. 8, the American Taxpayer Relief Act of 2012
Client expense: $200,677 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), President of the U.S., SENATE
See page three Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 6446 Improving Diagnostic Innovations Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 S. 1700 The Medical Device Regulatory Improvement Act S. 1865 The Patient Access to Medical Innovation Act S. 1943 Novel Device Regulatory Relief Act of 2011 S. 1995 Medical Device Patient Safety Act
Client expense: $70,000 · Firm income: Not reported
Government 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 & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), SENATE
See page 7 Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 6446 Improving Diagnostic Innovations Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 S. 1700 The Medical Device Regulatory Improvement Act S. 1865 The Patient Access to Medical Innovation Act S. 1943 Novel Device Regulatory Relief Act of 2011 S. 1995 Medical Device Patient Safety Act
Client expense: $70,000 · Firm income: Not reported
Government 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 & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), SENATE
See page five Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S.1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 6446 Improving Diagnostic Innovations Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 S. 1700 The Medical Device Regulatory Improvement Act S. 1865 The Patient Access to Medical Innovation Act S. 1943 Novel Device Regulatory Relief Act of 2011 S. 1995 Medical Device Patient Safety Act
Client expense: $70,000 · Firm income: Not reported
Government 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 & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), SENATE
2012 · fourth_quarter · Health Issues
Issues impacting the legislative and regulatory oversight of laboratory developed tests, reimbursement of diagnostic tests, DNA patents, workforce issues. No Bill#: Genomic Research and Accessibility Act; No Bill#: BETTER Patient Care Act; HR 3207: Modernizing Laboratory Test Standards for Patients Act; HR 3497 MODDERN Cures Act HR6446, Improving Diagnostic Innovations Act
Client expense: Not reported · Firm income: $30,000
Government targets: Agency for Healthcare Research & Quality (AHRQ), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE
2012 · fourth_quarter · Medical/Disease Research/Clinical Labs
Issues impacting the legislative and regulatory oversight of laboratory developed tests, reimbursement of diagnostic tests, DNA patents, workforce issues. No Bill#: Genomic Research and Accessibility Act; No Bill#: BETTER Patient Care; HR 3207: Modernizing Laboratory Test Standards for Patients Act; HR 3497 MODDERN Cures Act HR6446, Improving Diagnostic Innovations Act
Client expense: Not reported · Firm income: $30,000
Government targets: Agency for Healthcare Research & Quality (AHRQ), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE
2012 · fourth_quarter · Health Issues
HR 3207, The Modernizing Laboratory Test Standards for Patients Act of 2011, Issues associated with Laboratory Developed Tests. S. 3187, The Food and Drug Administration Safety and Innovation Act, provisions associated with Laboratory Developed Tests.
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2012 · fourth_quarter · Medicare/Medicaid
FDA regulation of laboratory developed tests. Medicare reimbursement for laboratory developed tests. HR 3207
Client expense: Not reported · Firm income: $20,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2012 · fourth_quarter · Medical/Disease Research/Clinical Labs
FDA regulation of laboratory developed tests. Medicare reimbursement for laboratory developed tests. HR 3207
Client expense: Not reported · Firm income: $20,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2012 · fourth_quarter · Health Issues
FDA regulation of laboratory developed tests. Medicare reimbursement for laboratory developed tests. HR 3207
Client expense: Not reported · Firm income: $20,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2012 · fourth_quarter · Medical/Disease Research/Clinical Labs
FDA regulation of laboratory developed tests. Medicare reimbursement for laboratory developed tests. HR 3207
Client expense: Not reported · Firm income: $10,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2012 · fourth_quarter · Health Issues
FDA regulation of laboratory developed tests. Medicare reimbursement for laboratory developed tests. HR 3207
Client expense: Not reported · Firm income: $10,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2012 · fourth_quarter · Medicare/Medicaid
FDA regulation of laboratory developed tests. Medicare reimbursement for laboratory developed tests. HR 3207
Client expense: Not reported · Firm income: $10,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2012 · fourth_quarter · Medical/Disease Research/Clinical Labs
Health reform law implementation issues including application of medical device tax to clinical laboratory tests and laboratory fee schedule. In-office ancillary services exception to Stark Law. H.R. 3207, The Modernizing Laboratory Test Standards for Patients Act. H.R. 6118, The Taking Essential Steps for Testing Act (Became PL 112-202 on December 4, 2012)
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2012 · third_quarter · Medical/Disease Research/Clinical Labs
Issues impacting the legislative and regulatory oversight of laboratory developed tests, reimbursement of diagnostic tests, DNA patents, workforce issues, standards development for diagnostics. No Bill#: Genomic Research and Accessibility Act; No Bill#: BETTER Patient Care; HR 3207: Modernizing Laboratory Test Standards for Patients Act; HR 3497 MODDERN Cures Act
Client expense: Not reported · Firm income: $30,000
Government targets: Agency for Healthcare Research & Quality (AHRQ), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE
2012 · third_quarter · Health Issues
Issues impacting the legislative and regulatory oversight of laboratory developed tests, reimbursement of diagnostic tests, DNA patents, workforce issues. No Bill#: Genomic Research and Accessibility Act; No Bill#: BETTER Patient Care Act; HR 3207: Modernizing Laboratory Test Standards for Patients Act; HR 3497 MODDERN Cures Act
Client expense: Not reported · Firm income: $30,000
Government targets: Agency for Healthcare Research & Quality (AHRQ), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE
2012 · second_quarter · Medical/Disease Research/Clinical Labs
Issues impacting the legislative and regulatory oversight of laboratory developed tests, reimbursement of diagnostic tests, DNA patents, workforce issues, standards development for diagnostics. No Bill#: Genomics and Personalized Medicine Act; No Bill#: Genomic Research and Accessibility Act; No Bill#: BETTER Patient Care; HR 3207: Modernizing Laboratory Test Standards for Patients Act; HR 3497 MODDERN Cures Act
Client expense: Not reported · Firm income: $30,000
Government targets: Agency for Healthcare Research & Quality (AHRQ), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE
2012 · second_quarter · Health Issues
Issues impacting the legislative and regulatory oversight of laboratory developed tests, reimbursement of diagnostic tests, DNA patents, workforce issues. No Bill#: Genomics and Personalized Medicine Act; No Bill#: Genomic Research and Accessibility Act; No Bill#: BETTER Patient Care Act; HR 3207: Modernizing Laboratory Test Standards for Patients Act; HR 3497 MODDERN Cures Act
Client expense: Not reported · Firm income: $30,000
Government targets: Agency for Healthcare Research & Quality (AHRQ), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE
2012 · first_quarter · Medical/Disease Research/Clinical Labs
Issues impacting the legislative and regulatory oversight of laboratory developed tests, reimbursement of diagnostic tests, DNA patents, workforce issues, standards development for diagnostics. No Bill#: Genomics and Personalized Medicine Act; No Bill#: Genomic Research and Accessibility Act; No Bill#: BETTER Patient Care; HR 1249, America Invents Act; HR 3207: Modernizing Laboratory Test Standards for Patients Act; HR 3497 MODDERN Cures Act
Client expense: Not reported · Firm income: $30,000
Government targets: Agency for Healthcare Research & Quality (AHRQ), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE
2012 · first_quarter · Health Issues
Issues impacting the legislative and regulatory oversight of laboratory developed tests, reimbursement of diagnostic tests, DNA patents, workforce issues. No Bill#: Genomics and Personalized Medicine Act; No Bill#: Genomic Research and Accessibility Act; No Bill#: BETTER Patient Care Act; HR 1249, America Invents Act; HR 3207: Modernizing Laboratory Test Standards for Patients Act; HR 3497 MODDERN Cures Act
Client expense: Not reported · Firm income: $30,000
Government targets: Agency for Healthcare Research & Quality (AHRQ), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE
2012 · second_quarter · Health Issues
Issues related to the 510(k) process for medical devices. [Elizabeth Sharp, Elizabeth Kegler, JC Scott] Issues related to diagnostics in the critical care setting. [Leah Kegler, Duane Wright] Issues related to the medical device user fee program [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S. 3187 Food and Drug Administration Safety and Innovation Act [Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright] S. 2516 Food and Drug Administration Safety and Innovation Act [Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright] H.R. 5651 Food and Drug Administration Reform Act of 2012 [Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright] Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. [Elizabeth Sharp, Elizabeth Kegler, JC Scott] Issues related to diagnostics regulation [Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright] Issues related to the definition of durable for durable medical equipment [Duane Wright] HR 3209 Premarket Predictability Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3203 Novel Device Regulatory Relief Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3230 Keeping America Competitive Through Harmonization Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3205 FDA Renewing Efficiency From Outside Reviewer Management Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3211 Humanitarian Device Reform Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3208 Patients Come First Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3206 Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3214 Food and Drug Administration Mission Reform Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3207 Modernizing Laboratory Test Standards for Patients Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright] HR 3204 Guidance Accountability and Transparency Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3847 Safety of Untested and New Devices Act of 2012 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3975 a bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 [Elizabeth Sharp, Elizabeth Kegler] HR 4056 Science and Technology Regulatory Relief Act [Elizabeth Sharp, Elizabeth Kegler] S 1700 Medical Device Regulatory Improvement Act[Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 1865 Patient Access to Medical Innovation Act [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 1943 Novel Device Regulatory Relief Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 1972 Food and Drug Administration Mission Reform Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 1995 Medical Device Patient Safety Act[Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 2067 Safe, Transparent, and Efficient Medical Device Act [Elizabeth Sharp, Elizabeth Kegler] S 2113 A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that encourage innovative products to benefit patients and improve public health [Elizabeth Sharp] S 2193 Ensuring Safe Medical Devices for Patients [Elizabeth Sharp, Elizabeth Kegler] S 2292 PATIENTS' FDA Act [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S. 2289 Better Pharmaceuticals and Devices for Children Act of 2012 [Elizabeth Sharp]
Client expense: $366,862 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2012 · third_quarter · Health Issues
Health reform law implementation issues including application of medical device tax to clinical laboratories; in-office ancillary services exception to the Stark law; H.R. 3207, the Modernizing Laboratory Test Standards for Patients Act; H.R. 6118.S.3391, the Taking Essential Steps for Testing Act; the coding and pricing and placement of molecular pathology laboratory tests
Client expense: $191,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE