LAB Act

regulation and oversight of clinical laboratories, including laboratory developed test services and pharmacogenetic testing, the Diagnostic Accuracy and Innovation Act discussion draft and Verifying Accurate, Leading-edge IVCT Development Act discussion draft; reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, physician fee schedule, new test coding and pricing, TRICARE coverage and reimbursement, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); narrowing the in-office ancillary services exception to the federal self-referral statute to remove anatomic pathology, advanced diagnostic imaging, physical therapy, and radiation therapy; Medicare physician signature documentation requirements; National Diabetes Prevention Program; commercial laboratory surge capacity issues for response to pandemic/epidemic/public health crises, Anti-Kickback Law relating to clinical laboratories, surprise billing issues relating to clinical laboratory and ancillary providers. Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2020; Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2020; Medicare reimbursement of clinical laboratory services; SUPPORT for Patients and Communities Act (PL 115-271), H.R. 3584/S. 3049 Laboratory Access for Beneficiaries Act, H.R. 3630 No Surprises Act, S. 1895 Lower Health Care Costs Act, S. 1531 Stopping The Outrageous Practice of Surprise Medical Bills Act of 2019, S. 1266 Protecting Patients from Surprise Medical Bills Act, H.R. 3502 Protecting People from Surprise Medical Bills Act, H.R. 861 End Surprise Billing Act of 2019, H.R. 2328 Reauthorizing and Extending Americas Community Health Act, H.R. 3107 Improving Seniors' Timely Access to Care Act of 2019, H.R. 2143 Promoting Integrity in Medicare Act of 2019, H.R. 269 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, S. 1379 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, H.R. 3055 Commerce, Justice, Science, Agriculture, Rural Development, Food and Drug Administration, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2020, H.R. 2740 Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020, H.R. 4378 Continuing Appropriations Act, 2020, and Health Extenders Act, H.R. 3055 Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019, H.R. 1158 Consolidated Appropriations Act, 2020, H.R. 1865 Further Consolidated Appropriations Act, 2020. COVID-19 Pandemic Crisis Response, including COVID-19 laboratory capacity and testing, PL 116-123 Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020, PL 116-127 Families First Coronavirus Response Act, PL 116-136 Coronavirus AID, Relief, and Economic Security Act (CARES Act/H.R. 748/S.3548), PL 116-139 Paycheck Protection Program and Health Care Enhancement Act, H.R.6800 - Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, H.R.6585 - Equitable Data Collection and Disclosure on COVID-19 Act, S.3850 - Equitable Data Collection and Disclosure on COVID-19 Act, S.4198 - A bill to require health plans to provide coverage for COVID-19 serology testing, H.R.7667 - Commerce, Justice, Science, and Related Agencies Appropriations Act, 2021, H.R.7610 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2021, H.R.7614 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2021, H.R.7615 - To provide a payroll tax credit for certain expenses associated with protecting employees from COVID-19, H.R.7658 - To provide a payroll tax credit for certain costs of providing employees with testing for COVID-19, S.4214 - A bill to provide a payroll tax credit for certain expenses associated with protecting employees from COVID-19, S.4198 - Affordable Coronavirus Testing Act, H.R. 925 - Updated Heroes Act, S.178 - Uighur Intervention and Global Humanitarian Unified Response Act of 2019, S.4318 - American Workers, Families, and Employers Assistance Act, S.4322 - Safely Back to School and Back to Work Act, S.4740 - Public Health Infrastructure Saves Lives Act, H.R.8337 - Continuing Appropriations Act, 2021 and Other Extensions Act, H.R.133 Consolidated Appropriations Act, 2021, H.R.8900 Further Continuing Appropriations Act, 2021, and Other Extensions Act, H.R.1520 Further Extension of Continuing Appropriations Act, 2021.

Client expense: $450,946 · Firm income: Not reported

Government targets: 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), SENATE

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services); Policies impacting Medicare coverage and reimbursement for clinical laboratory services; FDA regulation of clinical laboratory services; Coronavirus impact and response; Surprise billing; Implementation of H.R.3584/S.3049, Laboratory Access for Beneficiaries Act (P.L.116-94); FY2021 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act (H.R.7614) and FY2021 Consolidated Appropriations Act (H.R.7617); Implementation of H.R.6201, Families First Coronavirus Response Act (P.L.116-127); Implementation of H.R.748, CARES Act (P.L.116-136); H.R.6800, The Heroes Act; Implementation of H.R.266, Paycheck Protection Program and Health Care Enhancement Act (P.L.116-139); H.R.8337, Continuing Appropriations Act, 2021 and Other Extensions Act; H.R.133, Making consolidated appropriations for the fiscal year ending September 30, 2021, providing coronavirus emergency response and relief, and for other purposes (P.L.116-260).

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

regulation and oversight of clinical laboratories, including laboratory developed test services and pharmacogenetic testing, the Diagnostic Accuracy and Innovation Act discussion draft and Verifying Accurate, Leading-edge IVCT Development Act discussion draft; reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, physician fee schedule, new test coding and pricing, TRICARE coverage and reimbursement, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); narrowing the in-office ancillary services exception to the federal self-referral statute to remove anatomic pathology, advanced diagnostic imaging, physical therapy, and radiation therapy; Medicare physician signature documentation requirements; National Diabetes Prevention Program; commercial laboratory surge capacity issues for response to pandemic/epidemic/public health crises, Anti-Kickback Law relating to clinical laboratories, surprise billing issues relating to clinical laboratory and ancillary providers. Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2020; Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2020; Medicare reimbursement of clinical laboratory services; SUPPORT for Patients and Communities Act (PL 115-271), H.R. 3584/S. 3049 Laboratory Access for Beneficiaries Act, H.R. 3630 No Surprises Act, S. 1895 Lower Health Care Costs Act, S. 1531 Stopping The Outrageous Practice of Surprise Medical Bills Act of 2019, S. 1266 Protecting Patients from Surprise Medical Bills Act, H.R. 3502 Protecting People from Surprise Medical Bills Act, H.R. 861 End Surprise Billing Act of 2019, H.R. 2328 Reauthorizing and Extending Americas Community Health Act, H.R. 3107 Improving Seniors' Timely Access to Care Act of 2019, H.R. 2143 Promoting Integrity in Medicare Act of 2019, H.R. 269 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, S. 1379 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, H.R. 3055 Commerce, Justice, Science, Agriculture, Rural Development, Food and Drug Administration, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2020, H.R. 2740 Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020, H.R. 4378 Continuing Appropriations Act, 2020, and Health Extenders Act, H.R. 3055 Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019, H.R. 1158 Consolidated Appropriations Act, 2020, H.R. 1865 Further Consolidated Appropriations Act, 2020. COVID-19 Pandemic Crisis Response, including COVID-19 laboratory capacity and testing, PL 116-123 Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020, PL 116-127 Families First Coronavirus Response Act, PL 116-136 Coronavirus AID, Relief, and Economic Security Act (CARES Act/H.R. 748/S.3548), PL 116-139 Paycheck Protection Program and Health Care Enhancement Act, H.R.6800 - Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, H.R.6585 - Equitable Data Collection and Disclosure on COVID-19 Act, S.3850 - Equitable Data Collection and Disclosure on COVID-19 Act, S.4198 - A bill to require health plans to provide coverage for COVID-19 serology testing, H.R.7667 - Commerce, Justice, Science, and Related Agencies Appropriations Act, 2021, H.R.7610 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2021, H.R.7614 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2021, H.R.7615 - To provide a payroll tax credit for certain expenses associated with protecting employees from COVID-19, H.R.7658 - To provide a payroll tax credit for certain costs of providing employees with testing for COVID-19, S.4214 - A bill to provide a payroll tax credit for certain expenses associated with protecting employees from COVID-19, S.4198 - Affordable Coronavirus Testing Act, H.R. 925 - Updated Heroes Act, S.178 - Uighur Intervention and Global Humanitarian Unified Response Act of 2019, S.4318 - American Workers, Families, and Employers Assistance Act, S.4322 - Safely Back to School and Back to Work Act, S.4740 - Public Health Infrastructure Saves Lives Act, H.R.8337 - Continuing Appropriations Act, 2021 and Other Extensions Act.

regulation and oversight of clinical laboratories, including laboratory developed test services and pharmacogenetic testing, the Diagnostic Accuracy and Innovation Act discussion draft and Verifying Accurate, Leading-edge IVCT Development Act discussion draft; reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, physician fee schedule, new test coding and pricing, TRICARE coverage and reimbursement, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); narrowing the in-office ancillary services exception to the federal self-referral statute to remove anatomic pathology, advanced diagnostic imaging, physical therapy, and radiation therapy; Medicare physician signature documentation requirements; National Diabetes Prevention Program; commercial laboratory surge capacity issues for response to pandemic/epidemic/public health crises, Anti-Kickback Law relating to clinical laboratories, surprise billing issues relating to clinical laboratory and ancillary providers. Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2020; Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2020; Medicare reimbursement of clinical laboratory services; SUPPORT for Patients and Communities Act (PL 115-271), H.R. 3584/S. 3049 Laboratory Access for Beneficiaries Act, H.R. 3630 No Surprises Act, S. 1895 Lower Health Care Costs Act, S. 1531 Stopping The Outrageous Practice of Surprise Medical Bills Act of 2019, S. 1266 Protecting Patients from Surprise Medical Bills Act, H.R. 3502 Protecting People from Surprise Medical Bills Act, H.R. 861 End Surprise Billing Act of 2019, H.R. 2328 Reauthorizing and Extending Americas Community Health Act, H.R. 3107 Improving Seniors' Timely Access to Care Act of 2019, H.R. 2143 Promoting Integrity in Medicare Act of 2019, H.R. 269 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, S. 1379 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, H.R. 3055 Commerce, Justice, Science, Agriculture, Rural Development, Food and Drug Administration, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2020, H.R. 2740 Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020, H.R. 4378 Continuing Appropriations Act, 2020, and Health Extenders Act, H.R. 3055 Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019, H.R. 1158 Consolidated Appropriations Act, 2020, H.R. 1865 Further Consolidated Appropriations Act, 2020. COVID-19 Pandemic Crisis Response, including COVID-19 laboratory capacity and testing, PL 116-123 Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020, PL 116-127 Families First Coronavirus Response Act, PL 116-136 Coronavirus AID, Relief, and Economic Security Act (CARES Act/H.R. 748/S.3548), PL 116-139 Paycheck Protection Program and Health Care Enhancement Act, H.R.6800 - Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, H.R.6585 - Equitable Data Collection and Disclosure on COVID-19 Act, S.3850 - Equitable Data Collection and Disclosure on COVID-19 Act, S.4198 - A bill to require health plans to provide coverage for COVID-19 serology testing, H.R.7667 - Commerce, Justice, Science, and Related Agencies Appropriations Act, 2021, H.R.7610 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2021, H.R.7614 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2021, H.R.7615 - To provide a payroll tax credit for certain expenses associated with protecting employees from COVID-19, H.R.7658 - To provide a payroll tax credit for certain costs of providing employees with testing for COVID-19, S.4214 - A bill to provide a payroll tax credit for certain expenses associated with protecting employees from COVID-19, S.4198 - Affordable Coronavirus Testing Act, H.R. 925 - Updated Heroes Act, S.178 - Uighur Intervention and Global Humanitarian Unified Response Act of 2019, S.4318 - American Workers, Families, and Employers Assistance Act, S.4322 - Safely Back to School and Back to Work Act, S.4740 - Public Health Infrastructure Saves Lives Act, H.R.8337 - Continuing Appropriations Act, 2021 and Other Extensions Act.

regulation and oversight of clinical laboratories, including laboratory developed test services and pharmacogenetic testing, the Diagnostic Accuracy and Innovation Act discussion draft and Verifying Accurate, Leading-edge IVCT Development Act discussion draft; reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, physician fee schedule, new test coding and pricing, TRICARE coverage and reimbursement, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); narrowing the in-office ancillary services exception to the federal self-referral statute to remove anatomic pathology, advanced diagnostic imaging, physical therapy, and radiation therapy; Medicare physician signature documentation requirements; National Diabetes Prevention Program; commercial laboratory surge capacity issues for response to pandemic/epidemic/public health crises, Anti-Kickback Law relating to clinical laboratories, surprise billing issues relating to clinical laboratory and ancillary providers. Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2020; Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2020; Medicare reimbursement of clinical laboratory services; SUPPORT for Patients and Communities Act (PL 115-271), H.R. 3584/S. 3049 Laboratory Access for Beneficiaries Act, H.R. 3630 No Surprises Act, S. 1895 Lower Health Care Costs Act, S. 1531 Stopping The Outrageous Practice of Surprise Medical Bills Act of 2019, S. 1266 Protecting Patients from Surprise Medical Bills Act, H.R. 3502 Protecting People from Surprise Medical Bills Act, H.R. 861 End Surprise Billing Act of 2019, H.R. 2328 Reauthorizing and Extending Americas Community Health Act, H.R. 3107 Improving Seniors' Timely Access to Care Act of 2019, H.R. 2143 Promoting Integrity in Medicare Act of 2019, H.R. 269 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, S. 1379 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, H.R. 3055 Commerce, Justice, Science, Agriculture, Rural Development, Food and Drug Administration, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2020, H.R. 2740 Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020, H.R. 4378 Continuing Appropriations Act, 2020, and Health Extenders Act, H.R. 3055 Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019, H.R. 1158 Consolidated Appropriations Act, 2020, H.R. 1865 Further Consolidated Appropriations Act, 2020. COVID-19 Pandemic Crisis Response, including COVID-19 laboratory capacity and testing, PL 116-123 Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020, PL 116-127 Families First Coronavirus Response Act, PL 116-136 Coronavirus AID, Relief, and Economic Security Act (CARES Act/H.R. 748/S.3548), PL 116-139 Paycheck Protection Program and Health Care Enhancement Act, H.R.6800 - Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, H.R.6585 - Equitable Data Collection and Disclosure on COVID-19 Act, S.3850 - Equitable Data Collection and Disclosure on COVID-19 Act, S.4198 - A bill to require health plans to provide coverage for COVID-19 serology testing, H.R.7667 - Commerce, Justice, Science, and Related Agencies Appropriations Act, 2021, H.R.7610 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2021, H.R.7614 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2021, H.R.7615 - To provide a payroll tax credit for certain expenses associated with protecting employees from COVID-19, H.R.7658 - To provide a payroll tax credit for certain costs of providing employees with testing for COVID-19, S.4214 - A bill to provide a payroll tax credit for certain expenses associated with protecting employees from COVID-19, S.4198 - Affordable Coronavirus Testing Act, H.R. 925 - Updated Heroes Act, S.178 - Uighur Intervention and Global Humanitarian Unified Response Act of 2019, S.4318 - American Workers, Families, and Employers Assistance Act, S.4322 - Safely Back to School and Back to Work Act, S.4740 - Public Health Infrastructure Saves Lives Act, H.R.8337 - Continuing Appropriations Act, 2021 and Other Extensions Act.

reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, physician fee schedule, new test coding and pricing, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); narrowing the in-office ancillary services exception to the federal self-referral statute to remove anatomic pathology, advanced diagnostic imaging, physical therapy, and radiation therapy; Medicare physician signature documentation requirements; Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2020; Medicare reimbursement of clinical laboratory services; H.R. 3584/S. 3049 Laboratory Access for Beneficiaries Act, H.R. 3107 Improving Seniors' Timely Access to Care Act of 2019, H.R. 2143 Promoting Integrity in Medicare Act of 2019, H.R. 3055 Commerce, Justice, Science, Agriculture, Rural Development, Food and Drug Administration, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2020, H.R. 2740 Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020, H.R. 4378 Continuing Appropriations Act, 2020, and Health Extenders Act, H.R. 3055 Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019, H.R. 1158 Consolidated Appropriations Act, 2020, H.R. 1865 Further Consolidated Appropriations Act, 2020. COVID-19 Pandemic Crisis Response, including COVID-19 laboratory capacity and testing, PL 116-123 Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020, PL 116-127 Families First Coronavirus Response Act, PL 116-136 Coronavirus AID, Relief, and Economic Security Act (CARES Act/H.R. 748/S.3548), PL 116-139 Paycheck Protection Program and Health Care Enhancement Act, H.R.6800 - Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, H.R.6585 - Equitable Data Collection and Disclosure on COVID-19 Act, S.3850 - Equitable Data Collection and Disclosure on COVID-19 Act, S.4198 - A bill to require health plans to provide coverage for COVID-19 serology testing, H.R.7667 - Commerce, Justice, Science, and Related Agencies Appropriations Act, 2021, H.R.7610 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2021, H.R.7614 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2021.

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services); Policies impacting Medicare coverage and reimbursement for clinical laboratory services; FDA regulation of clinical laboratory services; Coronavirus impact and response; Implementation of H.R.3584/S.3049, Laboratory Access for Beneficiaries Act (P.L.116-94); FY2021 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act (H.R.7614) and FY2021 Consolidated Appropriations Act (H.R.7617); Implementation of H.R.6201, Families First Coronavirus Response Act (P.L.116-127); Implementation of H.R.748, CARES Act (P.L.116-136); H.R.6800, The Heroes Act; Implementation of H.R.266, Paycheck Protection Program and Health Care Enhancement Act (P.L.116-139); H.R.8337, Continuing Appropriations Act, 2021 and Other Extensions Act.

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

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

Medicare payment for clinical laboratories and diagnostic tests; Medicare payment for patient self testing for prothrombin time; HR 3584 and S.3049, Laboratory Access for Beneficiaries Act

Client expense: $130,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Medicare payment for clinical laboratories and diagnostic tests; Medicare payment for patient self testing for prothrombin time; HR 3584 and S.3049, Laboratory Access for Beneficiaries Act

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services); Policies impacting Medicare coverage and reimbursement for clinical laboratory services; FDA regulation of clinical laboratory services; Coronavirus impact and response; S.1895, Lower Health Care Costs Act of 2019; Implementation of H.R.3584/S.3049, Laboratory Access for Beneficiaries Act (P.L.116-94); FY2021 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations; H.R.6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L.116-123); H.R.6201, Families First Coronavirus Response Act (P.L.116-127); H.R.748, CARES Act (P.L.116-136); H.R.6800, The Heroes Act; H.R.266, Paycheck Protection Program and Health Care Enhancement Act (P.L.116-139).

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

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

regulation and oversight of clinical laboratories, including laboratory developed test services and pharmacogenetic testing, the Diagnostic Accuracy and Innovation Act discussion draft and Verifying Accurate, Leading-edge IVCT Development Act discussion draft; reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, physician fee schedule, new test coding and pricing, TRICARE coverage and reimbursement, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); narrowing the in-office ancillary services exception to the federal self-referral statute to remove anatomic pathology, advanced diagnostic imaging, physical therapy, and radiation therapy; Medicare physician signature documentation requirements; National Diabetes Prevention Program; commercial laboratory surge capacity issues for response to pandemic/epidemic/public health crises, Anti-Kickback Law relating to clinical laboratories, surprise billing issues relating to clinical laboratory and ancillary providers. Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2020; Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2020; Medicare reimbursement of clinical laboratory services; SUPPORT for Patients and Communities Act (PL 115-271), H.R. 3584/S. 3049 Laboratory Access for Beneficiaries Act, H.R. 3630 No Surprises Act, S. 1895 Lower Health Care Costs Act, S. 1531 Stopping The Outrageous Practice of Surprise Medical Bills Act of 2019, S. 1266 Protecting Patients from Surprise Medical Bills Act, H.R. 3502 Protecting People from Surprise Medical Bills Act, H.R. 861 End Surprise Billing Act of 2019, H.R. 2328 Reauthorizing and Extending Americas Community Health Act, H.R. 3107 Improving Seniors' Timely Access to Care Act of 2019, H.R. 2143 Promoting Integrity in Medicare Act of 2019, H.R. 269 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, S. 1379 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, H.R. 3055 Commerce, Justice, Science, Agriculture, Rural Development, Food and Drug Administration, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2020, H.R. 2740 Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020, H.R. 4378 Continuing Appropriations Act, 2020, and Health Extenders Act, H.R. 3055 Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019, H.R. 1158 Consolidated Appropriations Act, 2020, H.R. 1865 Further Consolidated Appropriations Act, 2020. COVID-19 Pandemic Crisis Response, including COVID-19 laboratory capacity and testing, PL 116-123 Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020, PL 116-127 Families First Coronavirus Response Act, PL 116-136 Coronavirus AID, Relief, and Economic Security Act (CARES Act/H.R. 748/S.3548), PL 116-139 Paycheck Protection Program and Health Care Enhancement Act, H.R.6800 - Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, H.R.6585 - Equitable Data Collection and Disclosure on COVID-19 Act, S.3850 - Equitable Data Collection and Disclosure on COVID-19 Act, S.4198 - A bill to require health plans to provide coverage for COVID-19 serology testing, H.R.7667 - Commerce, Justice, Science, and Related Agencies Appropriations Act, 2021, H.R.7610 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2021, H.R.7614 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2021.

regulation and oversight of clinical laboratories, including laboratory developed test services and pharmacogenetic testing, the Diagnostic Accuracy and Innovation Act discussion draft and Verifying Accurate, Leading-edge IVCT Development Act discussion draft; reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, physician fee schedule, new test coding and pricing, TRICARE coverage and reimbursement, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); narrowing the in-office ancillary services exception to the federal self-referral statute to remove anatomic pathology, advanced diagnostic imaging, physical therapy, and radiation therapy; Medicare physician signature documentation requirements; National Diabetes Prevention Program; commercial laboratory surge capacity issues for response to pandemic/epidemic/public health crises, Anti-Kickback Law relating to clinical laboratories, surprise billing issues relating to clinical laboratory and ancillary providers. Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2020; Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2020; Medicare reimbursement of clinical laboratory services; SUPPORT for Patients and Communities Act (PL 115-271), H.R. 3584/S. 3049 Laboratory Access for Beneficiaries Act, H.R. 3630 No Surprises Act, S. 1895 Lower Health Care Costs Act, S. 1531 Stopping The Outrageous Practice of Surprise Medical Bills Act of 2019, S. 1266 Protecting Patients from Surprise Medical Bills Act, H.R. 3502 Protecting People from Surprise Medical Bills Act, H.R. 861 End Surprise Billing Act of 2019, H.R. 2328 Reauthorizing and Extending Americas Community Health Act, H.R. 3107 Improving Seniors' Timely Access to Care Act of 2019, H.R. 2143 Promoting Integrity in Medicare Act of 2019, H.R. 269 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, S. 1379 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, H.R. 3055 Commerce, Justice, Science, Agriculture, Rural Development, Food and Drug Administration, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2020, H.R. 2740 Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020, H.R. 4378 Continuing Appropriations Act, 2020, and Health Extenders Act, H.R. 3055 Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019, H.R. 1158 Consolidated Appropriations Act, 2020, H.R. 1865 Further Consolidated Appropriations Act, 2020. COVID-19 Pandemic Crisis Response, including COVID-19 laboratory capacity and testing, PL 116-123 Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020, PL 116-127 Families First Coronavirus Response Act, PL 116-136 Coronavirus AID, Relief, and Economic Security Act (CARES Act/H.R. 748/S.3548), PL 116-139 Paycheck Protection Program and Health Care Enhancement Act, H.R.6800 - Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, H.R.6585 - Equitable Data Collection and Disclosure on COVID-19 Act, S.3850 - Equitable Data Collection and Disclosure on COVID-19 Act, S.4198 - A bill to require health plans to provide coverage for COVID-19 serology testing, H.R.7667 - Commerce, Justice, Science, and Related Agencies Appropriations Act, 2021, H.R.7610 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2021, H.R.7614 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2021.

regulation and oversight of clinical laboratories, including laboratory developed test services and pharmacogenetic testing, the Diagnostic Accuracy and Innovation Act discussion draft and Verifying Accurate, Leading-edge IVCT Development Act discussion draft; reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, physician fee schedule, new test coding and pricing, TRICARE coverage and reimbursement, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); narrowing the in-office ancillary services exception to the federal self-referral statute to remove anatomic pathology, advanced diagnostic imaging, physical therapy, and radiation therapy; Medicare physician signature documentation requirements; National Diabetes Prevention Program; commercial laboratory surge capacity issues for response to pandemic/epidemic/public health crises, Anti-Kickback Law relating to clinical laboratories, surprise billing issues relating to clinical laboratory and ancillary providers. Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2020; Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2020; Medicare reimbursement of clinical laboratory services; SUPPORT for Patients and Communities Act (PL 115-271), H.R. 3584/S. 3049 Laboratory Access for Beneficiaries Act, H.R. 3630 No Surprises Act, S. 1895 Lower Health Care Costs Act, S. 1531 Stopping The Outrageous Practice of Surprise Medical Bills Act of 2019, S. 1266 Protecting Patients from Surprise Medical Bills Act, H.R. 3502 Protecting People from Surprise Medical Bills Act, H.R. 861 End Surprise Billing Act of 2019, H.R. 2328 Reauthorizing and Extending Americas Community Health Act, H.R. 3107 Improving Seniors' Timely Access to Care Act of 2019, H.R. 2143 Promoting Integrity in Medicare Act of 2019, H.R. 269 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, S. 1379 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, H.R. 3055 Commerce, Justice, Science, Agriculture, Rural Development, Food and Drug Administration, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2020, H.R. 2740 Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020, H.R. 4378 Continuing Appropriations Act, 2020, and Health Extenders Act, H.R. 3055 Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019, H.R. 1158 Consolidated Appropriations Act, 2020, H.R. 1865 Further Consolidated Appropriations Act, 2020. COVID-19 Pandemic Crisis Response, including COVID-19 laboratory capacity and testing, PL 116-123 Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020, PL 116-127 Families First Coronavirus Response Act, PL 116-136 Coronavirus AID, Relief, and Economic Security Act (CARES Act/H.R. 748/S.3548), PL 116-139 Paycheck Protection Program and Health Care Enhancement Act, H.R.6800 - Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, H.R.6585 - Equitable Data Collection and Disclosure on COVID-19 Act, S.3850 - Equitable Data Collection and Disclosure on COVID-19 Act, S.4198 - A bill to require health plans to provide coverage for COVID-19 serology testing, H.R.7667 - Commerce, Justice, Science, and Related Agencies Appropriations Act, 2021, H.R.7610 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2021, H.R.7614 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2021.

reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, physician fee schedule, new test coding and pricing, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); narrowing the in-office ancillary services exception to the federal self-referral statute to remove anatomic pathology, advanced diagnostic imaging, physical therapy, and radiation therapy; Medicare physician signature documentation requirements; Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2020; Medicare reimbursement of clinical laboratory services; H.R. 3584/S. 3049 Laboratory Access for Beneficiaries Act, H.R. 3107 Improving Seniors' Timely Access to Care Act of 2019, H.R. 2143 Promoting Integrity in Medicare Act of 2019, H.R. 3055 Commerce, Justice, Science, Agriculture, Rural Development, Food and Drug Administration, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2020, H.R. 2740 Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020, H.R. 4378 Continuing Appropriations Act, 2020, and Health Extenders Act, H.R. 3055 Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019, H.R. 1158 Consolidated Appropriations Act, 2020, H.R. 1865 Further Consolidated Appropriations Act, 2020. COVID-19 Pandemic Crisis Response, including COVID-19 laboratory capacity and testing, PL 116-123 Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020, PL 116-127 Families First Coronavirus Response Act, PL 116-136 Coronavirus AID, Relief, and Economic Security Act (CARES Act/H.R. 748/S.3548), PL 116-139 Paycheck Protection Program and Health Care Enhancement Act, H.R.6800 - Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, H.R.6585 - Equitable Data Collection and Disclosure on COVID-19 Act, S.3850 - Equitable Data Collection and Disclosure on COVID-19 Act, S.4198 - A bill to require health plans to provide coverage for COVID-19 serology testing, H.R.7667 - Commerce, Justice, Science, and Related Agencies Appropriations Act, 2021, H.R.7610 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2021, H.R.7614 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2021.

Healthcare issues related to clinical laboratories; H.R. 6102/S. 3404, the Verifying Accurate Leading-edge IVCT Development (VALID) Act, provisions relating to FDA oversight of laboratory-developed tests; Federal policy relating to FDA oversight of pharmacogenetic tests, including potential inclusion in the Fiscal Year 2021 Agriculture-FDA appropriations bill; H.R. 748, the Coronavirus Aid, Relief, and Economic Security (CARES) Act, provisions relating to coverage and reimbursement of COVID-19 diagnostic tests, Medicare reimbursement for clinical laboratory tests, funding for child care for laboratory personnel, and emergency funding for COVID-19 related revenue losses and expenses not otherwise reimbursed; H.R. 3584/ S. 3049, the Laboratory Access for Beneficiaries (LAB) Act, provisions relating to modification of reporting of private-sector payments used to establish Medicare rates for clinical diagnostic laboratory tests and directing a third party study and report including recommendations on private-sector payment data collection requirements and Medicare rate methodologies. H.R. 1865, the Further Consolidated Appropriations Act, Section 105 of Division N, provisions incorporating the LAB Act; Federal policy relating to drug development; and Federal policy relating to anti-kickback requirements in Section 8122 of the Support for Patients and Communities Act, Pub. L. 115-271 (18 U.S.C. 220) including potential inclusion in the Fiscal Year 2021 Labor-HHS appropriations bill.

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

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services); Policies impacting Medicare coverage and reimbursement for clinical laboratory services; FDA regulation of clinical laboratory services; Coronavirus impact and response; S.1895, Lower Health Care Costs Act of 2019; H.R.3584/S.3049, Laboratory Access for Beneficiaries Act; FY2021 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations; H.R.6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L.116-123); H.R.6201, Families First Coronavirus Response Act (P.L.116-127); H.R.748, CARES Act (P.L.116-136).

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

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

reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, physician fee schedule, new test coding and pricing, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); narrowing the in-office ancillary services exception to the federal self-referral statute to remove anatomic pathology, advanced diagnostic imaging, physical therapy, and radiation therapy; Medicare physician signature documentation requirements; Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2020; Medicare reimbursement of clinical laboratory services; H.R. 3584/S. 3049 Laboratory Access for Beneficiaries Act, H.R. 3630 No Surprises Act, S. 1895 Lower Health Care Costs Act, H.R. 2328 Reauthorizing and Extending Americas Community Health Act, H.R. 3107 Improving Seniors' Timely Access to Care Act of 2019, H.R. 2143 Promoting Integrity in Medicare Act of 2019, H.R. 3055 Commerce, Justice, Science, Agriculture, Rural Development, Food and Drug Administration, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2020, H.R. 2740 Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020, H.R. 4378 Continuing Appropriations Act, 2020, and Health Extenders Act, H.R. 3055 Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019, H.R. 1158 Consolidated Appropriations Act, 2020, H.R. 1865 Further Consolidated Appropriations Act, 2020. COVID-19 Pandemic Crisis Response, including COVID-19 laboratory capacity and testing, PL 116-123 Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020, PL 116-127 Families First Coronavirus Response Act, PL 116-136 Coronavirus AID, Relief, and Economic Security Act (CARES Act/H.R. 748/S.3548).

reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, physician fee schedule, new test coding and pricing, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); narrowing the in-office ancillary services exception to the federal self-referral statute to remove anatomic pathology, advanced diagnostic imaging, physical therapy, and radiation therapy; Medicare physician signature documentation requirements; Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2020; Medicare reimbursement of clinical laboratory services; H.R. 3584/S. 3049 Laboratory Access for Beneficiaries Act, H.R. 3630 No Surprises Act, S. 1895 Lower Health Care Costs Act, H.R. 2328 Reauthorizing and Extending Americas Community Health Act, H.R. 3107 Improving Seniors' Timely Access to Care Act of 2019, H.R. 2143 Promoting Integrity in Medicare Act of 2019, H.R. 3055 Commerce, Justice, Science, Agriculture, Rural Development, Food and Drug Administration, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2020, H.R. 2740 Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020, H.R. 4378 Continuing Appropriations Act, 2020, and Health Extenders Act, H.R. 3055 Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019, H.R. 1158 Consolidated Appropriations Act, 2020, H.R. 1865 Further Consolidated Appropriations Act, 2020. COVID-19 Pandemic Crisis Response, including COVID-19 laboratory capacity and testing, PL 116-123 Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020, PL 116-127 Families First Coronavirus Response Act, PL 116-136 Coronavirus AID, Relief, and Economic Security Act (CARES Act/H.R. 748/S.3548).

regulation and oversight of clinical laboratories, including laboratory developed test services and pharmacogenetic testing, the Diagnostic Accuracy and Innovation Act discussion draft and Verifying Accurate, Leading-edge IVCT Development Act discussion draft; reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, physician fee schedule, new test coding and pricing, TRICARE coverage and reimbursement, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); narrowing the in-office ancillary services exception to the federal self-referral statute to remove anatomic pathology, advanced diagnostic imaging, physical therapy, and radiation therapy; Medicare physician signature documentation requirements; National Diabetes Prevention Program; commercial laboratory surge capacity issues for response to pandemic/epidemic/public health crises, Anti-Kickback Law relating to clinical laboratories, surprise billing issues relating to clinical laboratory and ancillary providers. Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2020; Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2020; Medicare reimbursement of clinical laboratory services; SUPPORT for Patients and Communities Act (PL 115-271), H.R. 3584/S. 3049 Laboratory Access for Beneficiaries Act, H.R. 3630 No Surprises Act, S. 1895 Lower Health Care Costs Act, S. 1531 Stopping The Outrageous Practice of Surprise Medical Bills Act of 2019, S. 1266 Protecting Patients from Surprise Medical Bills Act, H.R. 3502 Protecting People from Surprise Medical Bills Act, H.R. 861 End Surprise Billing Act of 2019, H.R. 2328 Reauthorizing and Extending Americas Community Health Act, H.R. 3107 Improving Seniors' Timely Access to Care Act of 2019, H.R. 2143 Promoting Integrity in Medicare Act of 2019, H.R. 269 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, S. 1379 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, H.R. 3055 Commerce, Justice, Science, Agriculture, Rural Development, Food and Drug Administration, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2020, H.R. 2740 Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020, H.R. 4378 Continuing Appropriations Act, 2020, and Health Extenders Act, H.R. 3055 Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019, H.R. 1158 Consolidated Appropriations Act, 2020, H.R. 1865 Further Consolidated Appropriations Act, 2020. COVID-19 Pandemic Crisis Response, including COVID-19 laboratory capacity and testing, PL 116-123 Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020, PL 116-127 Families First Coronavirus Response Act, PL 116-136 Coronavirus AID, Relief, and Economic Security Act (CARES Act/H.R. 748/S.3548).

reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, physician fee schedule, new test coding and pricing, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); narrowing the in-office ancillary services exception to the federal self-referral statute to remove anatomic pathology, advanced diagnostic imaging, physical therapy, and radiation therapy; Medicare physician signature documentation requirements; Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2020; Medicare reimbursement of clinical laboratory services; H.R. 3584/S. 3049 Laboratory Access for Beneficiaries Act, H.R. 3630 No Surprises Act, S. 1895 Lower Health Care Costs Act, H.R. 2328 Reauthorizing and Extending Americas Community Health Act, H.R. 3107 Improving Seniors' Timely Access to Care Act of 2019, H.R. 2143 Promoting Integrity in Medicare Act of 2019, H.R. 3055 Commerce, Justice, Science, Agriculture, Rural Development, Food and Drug Administration, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2020, H.R. 2740 Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020, H.R. 4378 Continuing Appropriations Act, 2020, and Health Extenders Act, H.R. 3055 Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019, H.R. 1158 Consolidated Appropriations Act, 2020, H.R. 1865 Further Consolidated Appropriations Act, 2020. COVID-19 Pandemic Crisis Response, including COVID-19 laboratory capacity and testing, PL 116-123 Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020, PL 116-127 Families First Coronavirus Response Act, PL 116-136 Coronavirus AID, Relief, and Economic Security Act (CARES Act/H.R. 748/S.3548).

Medicare payment for clinical laboratories and diagnostic tests; Medicare payment for patient self testing for prothrombin time; HR 3584 and S.3049, Laboratory Access for Beneficiaries Act

Client expense: $110,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Healthcare issues related to clinical laboratories; FDA oversight of laboratory-developed tests, including the discussion draft of the Verifying Accurate Leading-edge IVCT Development (VALID) Act; H.R. 3584/ S. 3049, the Laboratory Access for Beneficiaries (LAB) Act, provisions relating to modification of reporting of private-sector payments used to establish Medicare rates for clinical diagnostic laboratory tests and directing a third party study and report including recommendations on private-sector payment data collection requirements and Medicare rate methodologies. H.R. 1865, the Further Consolidated Appropriations Act, Section 105 of Division N, provisions incorporating the LAB Act; Federal policy relating to drug development; and Federal policy relating to anti-kickback requirements in Section 8122 of the Support for Patients and Communities Act, Pub. L. 115-271 (18 U.S.C. 220).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of P.L.113-93, Protecting Access to Medicare Act of 2014 (changes to reimbursement for clinical laboratory services). Policies impacting Medicare coverage and reimbursement for clinical laboratory services. FDA regulation of clinical laboratory services. H.R.2740, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2020; H.R.1865, Further Consolidated Appropriations Act, 2020 (P.L.116-94). S.1895, Lower Health Care Costs Act of 2019. H.R.3584/S.3049, Laboratory Access for Beneficiaries Act.

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

Government targets: Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, SENATE

Medicare payment for clinical laboratories and diagnostic tests; Medicare payment for patient self testing for prothrombin time; HR 3584 and S.3049, Laboratory Access for Beneficiaries Act)

Client expense: $110,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

The Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2018 Discussion draft; Laboratory Access for Beneficiaries Act, (H.R. 3584/S. 3049).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2018 Discussion draft; Laboratory Access for Beneficiaries Act, (H.R. 3584/S. 3049).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

regulation and oversight of clinical laboratories, including laboratory developed test services and pharmacogenetic testing, the Diagnostic Accuracy and Innovation Act discussion draft and Verifying Accurate, Leading-edge IVCT Development Act discussion draft; reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, physician fee schedule, new test coding and pricing, TRICARE coverage and reimbursement, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); narrowing the in-office ancillary services exception to the federal self-referral statute to remove anatomic pathology, advanced diagnostic imaging, physical therapy, and radiation therapy; Medicare physician signature documentation requirements; National Diabetes Prevention Program; commercial laboratory surge capacity issues for response to pandemic/epidemic/public health crises, Anti-Kickback Law relating to clinical laboratories, surprise billing issues relating to clinical laboratory and ancillary providers. Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2020; Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2020; Medicare reimbursement of clinical laboratory services; SUPPORT for Patients and Communities Act (PL 115-271), H.R. 3584/S. 3049 Laboratory Access for Beneficiaries Act, H.R. 3630 No Surprises Act, S. 1895 Lower Health Care Costs Act, S. 1531 Stopping The Outrageous Practice of Surprise Medical Bills Act of 2019, S. 1266 Protecting Patients from Surprise Medical Bills Act, H.R. 3502 Protecting People from Surprise Medical Bills Act, H.R. 861 End Surprise Billing Act of 2019, H.R. 2328 Reauthorizing and Extending Americas Community Health Act, H.R. 3107 Improving Seniors' Timely Access to Care Act of 2019, H.R. 2143 Promoting Integrity in Medicare Act of 2019, H.R. 269 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, S. 1379 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, H.R. 3055 Commerce, Justice, Science, Agriculture, Rural Development, Food and Drug Administration, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2020, H.R. 2740 Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020, H.R. 4378 Continuing Appropriations Act, 2020, and Health Extenders Act, H.R. 3055 Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019, H.R. 1158 Consolidated Appropriations Act, 2020, H.R. 1865 Further Consolidated Appropriations Act, 2020.

regulation and oversight of clinical laboratories, including laboratory developed test services and pharmacogenetic testing, the Diagnostic Accuracy and Innovation Act discussion draft and Verifying Accurate, Leading-edge IVCT Development Act discussion draft; reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, physician fee schedule, new test coding and pricing, TRICARE coverage and reimbursement, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); narrowing the in-office ancillary services exception to the federal self-referral statute to remove anatomic pathology, advanced diagnostic imaging, physical therapy, and radiation therapy; Medicare physician signature documentation requirements; National Diabetes Prevention Program; commercial laboratory surge capacity issues for response to pandemic/epidemic/public health crises, Anti-Kickback Law relating to clinical laboratories, surprise billing issues relating to clinical laboratory and ancillary providers. Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2020; Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2020; Medicare reimbursement of clinical laboratory services; SUPPORT for Patients and Communities Act (PL 115-271), H.R. 3584/S. 3049 Laboratory Access for Beneficiaries Act, H.R. 3630 No Surprises Act, S. 1895 Lower Health Care Costs Act, S. 1531 Stopping The Outrageous Practice of Surprise Medical Bills Act of 2019, S. 1266 Protecting Patients from Surprise Medical Bills Act, H.R. 3502 Protecting People from Surprise Medical Bills Act, H.R. 861 End Surprise Billing Act of 2019, H.R. 2328 Reauthorizing and Extending Americas Community Health Act, H.R. 3107 Improving Seniors' Timely Access to Care Act of 2019, H.R. 2143 Promoting Integrity in Medicare Act of 2019, H.R. 269 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, S. 1379 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, H.R. 3055 Commerce, Justice, Science, Agriculture, Rural Development, Food and Drug Administration, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2020, H.R. 2740 Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020, H.R. 4378 Continuing Appropriations Act, 2020, and Health Extenders Act, H.R. 3055 Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019, H.R. 1158 Consolidated Appropriations Act, 2020, H.R. 1865 Further Consolidated Appropriations Act, 2020.

regulation and oversight of clinical laboratories, including laboratory developed test services and pharmacogenetic testing, the Diagnostic Accuracy and Innovation Act discussion draft and Verifying Accurate, Leading-edge IVCT Development Act discussion draft; reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, physician fee schedule, new test coding and pricing, TRICARE coverage and reimbursement, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); narrowing the in-office ancillary services exception to the federal self-referral statute to remove anatomic pathology, advanced diagnostic imaging, physical therapy, and radiation therapy; Medicare physician signature documentation requirements; National Diabetes Prevention Program; commercial laboratory surge capacity issues for response to pandemic/epidemic/public health crises, Anti-Kickback Law relating to clinical laboratories, surprise billing issues relating to clinical laboratory and ancillary providers. Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2020; Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2020; Medicare reimbursement of clinical laboratory services; SUPPORT for Patients and Communities Act (PL 115-271), H.R. 3584/S. 3049 Laboratory Access for Beneficiaries Act, H.R. 3630 No Surprises Act, S. 1895 Lower Health Care Costs Act, S. 1531 Stopping The Outrageous Practice of Surprise Medical Bills Act of 2019, S. 1266 Protecting Patients from Surprise Medical Bills Act, H.R. 3502 Protecting People from Surprise Medical Bills Act, H.R. 861 End Surprise Billing Act of 2019, H.R. 2328 Reauthorizing and Extending Americas Community Health Act, H.R. 3107 Improving Seniors' Timely Access to Care Act of 2019, H.R. 2143 Promoting Integrity in Medicare Act of 2019, H.R. 269 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, S. 1379 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, H.R. 3055 Commerce, Justice, Science, Agriculture, Rural Development, Food and Drug Administration, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2020, H.R. 2740 Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020, H.R. 4378 Continuing Appropriations Act, 2020, and Health Extenders Act, H.R. 3055 Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019, H.R. 1158 Consolidated Appropriations Act, 2020, H.R. 1865 Further Consolidated Appropriations Act, 2020.

reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, physician fee schedule, new test coding and pricing, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); narrowing the in-office ancillary services exception to the federal self-referral statute to remove anatomic pathology, advanced diagnostic imaging, physical therapy, and radiation therapy; Medicare physician signature documentation requirements; Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2020; Medicare reimbursement of clinical laboratory services; H.R. 3584/S. 3049 Laboratory Access for Beneficiaries Act, H.R. 3630 No Surprises Act, S. 1895 Lower Health Care Costs Act, H.R. 2328 Reauthorizing and Extending Americas Community Health Act, H.R. 3107 Improving Seniors' Timely Access to Care Act of 2019, H.R. 2143 Promoting Integrity in Medicare Act of 2019, H.R. 3055 Commerce, Justice, Science, Agriculture, Rural Development, Food and Drug Administration, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2020, H.R. 2740 Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020, H.R. 4378 Continuing Appropriations Act, 2020, and Health Extenders Act, H.R. 3055 Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019, H.R. 1158 Consolidated Appropriations Act, 2020, H.R. 1865 Further Consolidated Appropriations Act, 2020.

Client expense: $324,826 · Firm income: Not reported

Healthcare issues related to clinical laboratories; FDA oversight of laboratory-developed tests, including the discussion draft of the Verifying Accurate Leading-edge IVCT Development (VALID) Act; H.R. 3584/ S. 3049, the Laboratory Access for Beneficiaries (LAB) Act, provisions relating to modification of reporting of private-sector payments used to establish Medicare rates for clinical diagnostic laboratory tests and directing a third party study and report including recommendations on private-sector payment data collection requirements and Medicare rate methodologies. H.R. 1865, the Further Consolidated Appropriations Act, Section 105 of Division N, provisions incorporating the LAB Act; H.R. 3235, the Access to Genetic Counselor Services Act, provisions relating to Medicare coverage of genetic counseling services, and S. 2246, the Removing Barriers to Allergy Diagnostic Tests Act, provisions relating to Medicare and Medicaid coverage of allergy diagnostic tests; Cures 2.0, potential legislative initiative (Reps. Upton and DeGette); Federal policy relating to drug development; Federal policy relating to anti-kickback requirements in Section 8122 of the Support for Patients and Communities Act, Pub. L. 115-271 (18 U.S.C. 220); Federal policy relating to subject matter eligibility for patents of laboratory tests; and H.R. 3630, the No Surprises Act, H.R. 2328, the Reauthorizing and Extending Americas Community Health (REACH) Act, and S. 1895, the Lower Health Care Costs Act, provisions relating to surprise medical billing.

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