mr VINCENT STINE

* On September 26, ADLM wrote to Rep.Richard Hudson (R-NC) in support of his legislation, H.R.5269, the Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act, which would create a new, more equitable Medicare clinical laboratory fee schedule.

*On August 15th, an ADLM led coalition of healthcare groups wrote to the House and Senate Labor, Health and Human Services, Education, & Relation Agencies subcommittees urging them to include $10 million in the FY26 budget for the Centers for Disease Control and Prevention (CDC) to improve pediatric reference intervals (PRIs). On September 29th, ADLM wrote to the Department of Health and Human Services urging it to providing $10 million to CDC to improve the quality of PRIs.

On July 9th, ADLM joined a coalition letter of more than 100 groups in writing to the Senate Health Education Labor & Pensions and House Energy and Commerce committees urging them to protect the integrity of the United States Preventive Services Task Force (USPSTF). On August 29th, ADLM wrote to Rep. Kelly Morrison (D-MN) in support of H.R.4709, the Newborn Screening Saves Lives Reauthorization Act, which would preserve advances in newborn screening programs.

* ADLM wrote letters to HHS Secretary Kennedy separately, and jointly, urging the reinstatement of the Clinical Laboratory Improvement Advisory Committee * ADLM wrote letters to HHS Secretary Kennedy separately, and jointly, urging the reinstatement of the Advisory Committee on Heritable Disorders in Newborns and Children * ADLM joined with other healthcare groups in urging HHS Secretary Kennedy to not appeal a federal court decision in ACLA vs FDA that ruled the agency did not have statutory authority over laboratory developed tests

* ADLM joined with other healthcare groups in writing to House and Senate Labor HHS subcommittee leaders urging that Congress appropriate $155 million for improving the CDC public health data network *ADLM joined with other healthcare groups in writing to House and Senate Labor HHS subcommittee leaders urging that Congress not approve proposed administration cuts in the HHS research, scientific, and health budgets *ADLM joined with other healthcare groups in writing to House and Senate Labor HHS subcommittee leaders urging that it appropriate $220 million in the FY26 budget for the National Center for Health Statistics * ADLM joined with other healthcare groups in writing to House and Senate Labor HHS subcommittee leaders urging Congress to appropriate $11.581 billion for CDC in the FY26 budget * ADLM joined with other healthcare groups in writing to House and Senate Labor HHS subcommittee leaders urging Congress to appropriate an additional $7.2 million in the FY26 CDC budget for harmonizing clinical laboratory test results * ADLM met with House and Senate congressional staff seeking support for including $10 million in the FY26 CDC budget to improve pediatric reference intervals

* ADLM conducted a briefing for congressional staff on the impact of the Food and Drug Administration laboratory developed test rule on children's health. * ADLM endorsed the Freedom for Lab Innovation and Testing Act, which would prevent the FDA from using federal funds to implement the LDT rule; the association also initiated a grassroots campaign in support of the bill. * ADLM joined a coalition letter to House and Senate leaders seeking congressional support for getting public health data restored to agency websites. * ADLM released a position statement raising concerns about barriers to children getting laboratory testing.

* ADLM organized and sent a coalition letter to key House and Senate appropriators in support of a $10 million increase in funding for the Centers for Disease Control and Preventing to improve pediatric reference intervals. * ADLM met with House and Senate congressional staff seeking an additional $7.2 million for the CDC to harmonize clinical laboratory testing results. * ADLM wrote to the National Institutes of Health objecting to proposed cuts in the indirect costs provided to healthcare institutions obtaining federal grants.

* On November 22, ADLM joined a coalition letter to House and Senate appropriators urging them to include House report language directing the FDA to pause implementation of the May 6, 2024 FDA rule on LDTs in any final budget agreement. * December 13, ADLM met with congressional staff to discuss efforts to obtain funding to improve the quality of pediatric reference intervals.

* On October 30, ADLM released a position statement on direct to consumer testing urging various federal agencies to improve the quality and oversight of such testing and to prosecute labs engaging in misleading or fraudulent practices. * On November 7, ADLM wrote to Rep. Deborah Ross endorsing H.R.9849, the Medical Laboratory Personnel Shortage Relief Act, which would use federal funding to reduce the healthcare shortage in underserved areas. * On November 20, ADLM wrote to President-elect Donald Trump's transition team urging him to withdraw the FDA's May 6, 2024 final rule regulating Laboratory Developed Tests. * On November 21, ADLM joined a coalition letter to President-elect Donald Trump's transition team urging him to withdraw the FDA's May 6, 2024 final rule regulating LDTs. * On December 10, ADLM wrote to the House and Senate Department of Government Efficiency (DOGE) caucuses urging them to support revocation of the May 6, 2024 final rule on LDTs.

* On July 7, ADLM joined with other healthcare providers in supporting a resolution to employ the Congressional Review Act as it pertains to the FDAs Proposed Rule, Docket No. FDA-2023-N-2177, Medical Devices: Laboratory Developed Tests. * On September 5, ADLM wrote to House and Senate leaders providing survey results indicating the clinical laboratories will have problems complying with the FDA final rule regulating LDTs. * On August 15 and September 4, ADLM initiated grassroots campaigns urging House and Senate members to support future legislative efforts to revoke the FDA LDT final rule. * On September 10th, ADLM participating in Rare Disease Congress Caucus outlining concern about FDA LDT final rule.

* On July 23, ADLM wrote to Senate Appropriators urging that House report language in support for the Centers for Disease Control and Prevention initiating efforts to improve pediatric reference intervals be included in the Senate Labor HHS Education and Related Agencies fiscal year 2025 appropriations bill. On September 25, ADLM wrote to the Department of Health and Human Services urging the Department to include funding for the harmonization of clinical laboratory test results and improving PRIs in the fiscal year 2026 budget. On August 7th, 21st, & September 9th ADLM conducted grassroots campaigns in support the Saving Access to Laboratory Services Act, which would modify the method used by the Centers for Medicare and Medicaid Services in setting reimbursement rates for laboratory tests.

* On April 30, ADLM joined with other healthcare groups in writing to House and Senate appropriators in support of providing $340 million to fund the Centers for Disease Control and Prevention Public Health Data Modernization program. *On May 14, ADLM joined with other healthcare groups in writing Senate appropriators in support of providing $100 mllion for the Public Health Workforce Loan Repayment Program and $50 million to launch a Bio-Preparedness Workforce Pilot Program in the FY25 budget. * On May 31, ADLM joined with other healthcare groups in submitting testimony to the Select Subcommittee on the Coronavirus Pandemic, Committee on Oversight and Accountability, in support of strengthening the nation's public health workforce.

* On April 2, ADLM provided feedback to Senator Bill Cassidy (R-LA) on the need diagnostic testing reform.v * On April 8, ADLM provided survey results to Senator Bill Cassidy (R-LA) illustrating problems with the Food and Drug Administration's October 3, 2023 proposed rule to regulate laboratory developed tests. * On June 24, 2024 ADLM provided additional survey results to Senate HELP and House Energy & Commerce Committee leaders identifying concerns with the May 6, 2024 FDA final rule on LDTs. * ADLM met with House and Senate legislative staff in support of the Saving Access to Laboratory Services Act, H.R.1835 & S.1000, and conducted a grassroots campaign in support of the bill. *ADLM conducted a grassroots campaign in support of congressional action to revoke the May 6, 2024 FDA rule on LDTs.

* On January 18, ADLM joined with other healthcare groups in writing to House and Senate appropriators in support of increased funding for federal newborn screening programs in the FY24 budget. *On February 26, ADLM joined with other healthcare groups in writing House and Senate appropriators in support of providing the Agency for Healthcare Research and Quality at least $500 million in the FY25 budget. * On March 18, an ADLM led coalition of more than 40 healthcare groups wrote to House and Senate appropriators requesting $10 million for the Centers for Disease Control and Prevention in the FY25 budget to improve pediatric reference intervals. * On March 22, an ADLM led coalition of more than 25 healthcare groups wrote to House and Senate appropriators seeking an additional $7.2 million in the FY25 budget for CDC to better harmonize clinical laboratory test results. * On March 28, ADLM joined with other healthcare groups in seeking $220 million in the FY25 budget for the National Center for Health Statistics.

On October 31, ADLM (formerly AACC) joined with 89 other organizations in requesting the Food and Drug Administration to extend its comment period for responding to Docket No. FDA-2023-N-2177, Medical Devices: Laboratory Developed Tests (LDTs). On November 1st, ADLM (formerly AACC) joined with other groups in writing to the leadership of the Senate Health Education Labor & Pensions and House Energy and Commerce committees urging that they address oversight of LDTs through the modernization of the CLIA regulations. On December 12th, ADLM (formerly AACC) wrote to the leaders of the Senate Health Education Labor & Pensions and House Energy and Commerce committees urging them to direct the Food and Drug Administration to withdrawal their proposed rule (Docket No. FDA-2023-N-2177, Medical Devices: Laboratory Developed Tests) governing LDTs.

ADLM (formerly AACC) held a briefing for congressional staff on October 10th, where it educated participants on the need to improve the quality of pediatric reference intervals and recommended the inclusion of $10 million in the FY25 budget for the Centers for Disease Control and Prevention (CDC) to take up this task. On November 3rd, ADLM (formerly AACC) joined with other healthcare groups in writing to key House and Senate appropriators recommending that Congress provide $40 million to the Centers for Disease Control and Prevention in the FY 24 budget for its Advanced Molecular Detection (AMD) program.

AACC/ADLM wrote a joint letter to the Secretary of the Department of Health and Human Services and the Director of the Office of Management and Budget seeking the inclusion of $10 million in the FY25 budget for the Centers for Disease Control and Prevention (CDC) to improve pediatric reference intervals and an additional $7.2 million for CDC to harmonize clinical laboratory test results (total $9.2 million), AACC/ADLM joined with other healthcare groups in writing to leaders within the House of Representatives and Senate in support of providing at least $187 million in the FY24 budget for the National Center for Health Statistics.

AACC/ADLM wrote and met with the Office of Management and Budget to raise concerns about advancing a proposed rule [Docket No. FDA-2023-N-2177], which would extend the authority of the Food and Drug Administration to regulate laboratory developed tests.

AACC submitted testimony to the Senate Labor HHS Subcommittee in support of providing $10 million to the Centers for Disease Control and Prevention (CDC) for improving pediatric reference intervals and an additional $7.2 million to CDC for harmonizing clinical laboratory test results. AACC sent a joint letter to the House and Senate Labor HHS Subcommittees leadership urging them to provide an additional $7.2 million to CDC to harmonize clinical laboratory test results.

AACC joined a coalition of healthcare providing in writing to the House and Senate leadership in support of S.1000/H.R.2377, the Saving Access to Laboratory Services Act (SALSA), which would update the methodology used by the Center for Medicare and Medicaid Services in setting laboratory fees. AACC sent a separate letter to Rep. Richard Hudson endorsing SALSA.

Joined with other healthcare organizations in writing to the House and Senate Labor HHS Subcommittees in support of providing $100 million for the Public Health Workforce Loan Repayment Program and $50 million to initiate a new Bio-Preparedness Workforce Pilot program in the FY24 Labor, Health and Human Services, Education, and related agencies appropriations bill. Joined with other healthcare organizations in writing to the House and Senate Labor HHS Subcommittees in support of providing $175 million for the Centers for Disease Control and Prevention Advanced Molecular Detection program in the FY24 Labor, Health and Human Services, Education, and related agencies appropriations bill. Joined with other healthcare organizations in writing to the House and Senate Labor HHS Subcommittees in support of providing $11.581 billion for the Centers for Disease Control and Prevention programs in the FY24 Labor, Health and Human Services, Education, and related agencies appropriations bill. Joined with other healthcare organizations in writing to the House and Senate Labor HHS Subcommittees in support of providing $215 million for the National Center for Health Statistics in the FY24 Labor, Health and Human Services, Education, and related agencies appropriations bill. Joined with other healthcare organizations in writing to the House and Senate Labor HHS Subcommittees in support of providing $500 million for the Agency for Healthcare Research and Quality in the FY24 Labor, Health and Human Services, Education, and related agencies appropriations bill. Joined with other healthcare organizations in writing to the House and Senate Labor HHS Subcommittees in support of providing $10 million for the Centers for Disease Control and Prevention to develop better pediatric reference intervals in the FY24 Labor, Health and Human Services, Education, and related agencies appropriations bill.

AACC wrote to the Centers for Disease Control and Clinical Laboratory Improvement Advisory Committee (CLIAC) urging the panel to conduct a public hearing on a proposal to recognize the Doctorate of Clinical Laboratory Sciences as an acceptable degree for serving as a high complexity laboratory director under the CLIA requirements.

* AACC met with House and Senate staff, conducted grassroots campaigns, and circulated an advocacy video urging legislators not to include the Verifying Accurate Leading-edge IVCT Development (VALID) Act in the Consolidated Appropriations Act, 2023 * AACC signed a joint letter to House and Senate leaders urging them not to include the Verifying Accurate Leading-edge IVCT Development (VALID) Act in the Consolidated Appropriations Act, 2023 * AACC signed a joint letter to House and Senate leaders and conducted a grassroots campaign urging legislators to include S.4449 - Saving Access to Laboratory Services Act in Consolidated Appropriations Act, 2023

AACC joined with other healthcare groups in urging legislators to support H.R.8188/S.4449, the Saving Access to Laboratory Services Act, which would update the Medicare payment structure for clinical laboratory service.

* AACC met with House and agency staff urging that funding in the Labor, HHS, Education, and Related Agencies appropriations bill be allocated to the Centers for Disease Control and Prevention so the agency could start work on improving pediatric reference intervals.

* AACC joined with other healthcare groups in urging the House and Senate committees on Labor, HHS, Education, and Related Agencies to provide $11 billion in funding for the Centers for Disease Control and Prevention in FY23. * AACC met with House and Senate staff recommending that $10 million be included in the Labor, HHS, Education, and Related Agencies appropriations bill for CDC to improve pediatric reference intervals. * AACC initiated grassroots campaigns directed towards the House and Senate urging legislators to provide $10 million for CDC to improve PRIs and increase its funding the agency's funding by $7.2 million to expand its program for harmonizing clinical laboratory test results.

AACC joined with other healthcare groups in providing input to the Senate HELP Committee on the provisions in the Food and Drug Administration Safety and Landmark Advances Act pertaining to the Verifying Accurate Leading-edge IVCT Development Act. AACC met with House and Senate staff and conducted a grassroots campaign urging Congress to keep the VALID Act out of the FDASLA legislation.

AACC joined with other healthcare groups in writing to the Senate HELP leadership endorsing S.3534, the Tracking Pathogens Act, which would support and enhance existing genomic sequencing and surveillance activities. AACC met with House and Senate staff urging that the Verifying Accurate Leading-edge IVCT Development (VALID) Act not be included in the Medical Device User Fee Amendments V legislative package that will be considered by Congress. AACC provided input to the Senate HELP committee on its draft "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act," which would rebuild and strengthen our nations public health infrastructure.

* AACC joined with other healthcare groups in urging the Senate Health, Education, Labor, and Pensions (HELP) Committee to support an increase in newborn screening funding in FY22 to $49 million. * AACC joined with other healthcare groups in urging House and Senate leaders to include the Newborn Screening Saves Lives Re-authorization Act in the omnibus budget package. * AACC joined with other healthcare groups in urging the House and Senate Labor, Health, Education and Pensions subcommittees to include $10 million for CDC in the FY23 Labor, HHS, Education and Related Agencies appropriations bill to improve pediatric reference intervals * AACC joined with other healthcare groups in urging the House and Senate Labor, Health, Education and Pensions subcommittees to include $500 in the FY23 Labor, HHS, Education and Related Agencies for the Agency for Healthcare Research and Quality * AACC joined with other healthcare groups in recommending that the House and Senate Labor, HHS, Education & Related Agencies subcommittees provide CDC with an additional $7.2 million to harmonize clinical laboratory test results. *AACC met with CDC personnel to discuss improving pediatric reference intervals and the harmonization of clinical laboratory test results

* AACC joined with other healthcare groups in urging House and Senate appropriators to include $40 million in the FY22 Labor HHS appropriations bill for the Centers for Disease Control and Prevention Advanced Molecular Detection Program. * AACC joined with other healthcare groups in urging House and Senate appropriators in include the $10.5 billion in funding set aside for the CDC in the House passed FY22 Labor HHS appropriations bill. * AACC joined with other healthcare groups in urging House and Senate leaders to support a $12 million increase in federal funding for Health Resources and Services Administration and CDC newborn screening included in the House FY22 Labor HHS appropriations bill

AACC joined with other healthcare groups in writing to House and Senate leaders seeking a delay in calendar year 2022 spending cuts in Medicare laboratory fees and laboratory requirements as required under the Protecting Access to Medicare Act. AACC joined with other healthcare groups in writing to the CDC requesting that the Clinical Laboratory Improvement Amendments Advisory Committee take up the issue of laboratory developed tests during one of its future public meetings. AACC wrote to the House and Senate sponsors of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, HR 4128 and S.2209, expressing concerns about the legislation.

AACC met with House and Senate staff to express support for including $10 million in the Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations Bill for the Centers for Disease Control and Prevention to improve pediatric reference intervals. AACC met with CDC staff to express its continued support for the harmonization of clinical laboratory test results. AACC released a position statement, Data Analytics and Laboratory Medicine, urging greater federal involvement in addressing issues pertaining to the use of healthcare data in improving patient care.

AACC met House and Senate staff to express opposition to H.R.4128 & S.2209, the Verifying Accurate Leading-edge IVCT Development (VALID) Act, which would extend Food and Drug Administration oversight to laboratory developed tests (LDTs). AACC joined with other healthcare groups in supporting S.1666, the Verified Innovative Testing in American Laboratories (VITAL) Act, which would codify the existing regulatory model for overseeing LDTs.

On May 21st, AACC wrote to HHS Secretary Becerra raising concerns about ongoing efforts to extend Food and Drug Administration oversight to laboratory developed tests.

On May 19th, AACC submitted testimony to the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies supporting an increase in funding for the Centers for Medicare Services in the fiscal year 2022 budget to expand its activities to harmonize clinical laboratory test results and initiate efforts to improve pediatric reference intervals. A similar document was sent to the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies on June 24th. AACC also reached out to several House offices to discuss including funding for CDC in the budget to improve pediatric reference intervals in the FY2022 budget as well.

On January 27, AACC wrote to the White House Pandemic Board raising issues pertaining to lab supply shortages involving COVID-19 testing and offering assistance. On February 2, AACC submitted a statement to the House Energy and Commerce Committee raising concerns about lab supply shortages pertaining to COVID-19 testing. On February 2, AACC wrote to House and Senate leaders expressing concerns about ongoing shortages of supplies needed to perform COVID-19 testing On February 15, AACC wrote to Rep. Roybal-Allard endorsing H.R482, the Newborn Screening Saves Lives Reauthorization Act On March 8, AACC wrote to Senator Paul endorsing the Verified Innovative Testing in American Laboratories Act On March 15, AACC wrote to Senator Hassan endorsing S.350, the Newborn Screening Saves Lives Reauthorization Act

On January 28, AACC wrote to HHS requesting that the Department reverse a cut in Medicare payments for certain COVID-19 tests when the results are not reported within two days of the specimen being collected.

On October 19, AACC wrote to the Centers for Disease Control and Prevention urging the agency to retain the current high complexity standards for laboratory directors under the Clinical Laboratory Improvement Amendments.

On October 5, AACC wrote to House and Senate leaders seeking greater federal involvement in the production and distribution of laboratory supplies needed to perform COVID-19 testing. On October 6, AACC wrote to the Vice-President seeking greater federal involvement in the production and distribution of laboratory supplies needed to perform COVID-19 testing. On December 2, AACC joined with other lab groups in writing to President-elect Biden in seeking his help in addressing the shortage of COVID-19 laboratory supplies once he assumes office. On December 8, AACC wrote to President-elect Biden seeking his help in reducing the shortage of lab supplies needed for COVID-19 testing once he assumes office as well recommending that he repeal the Centers for Medicare and Medicaid Services October 15, 2020 decision to cut fees for certain COVID-19 tests by 25% if they are not completed within two days.

On July 8, AACC joined with other laboratory groups in writing to Vice-President Pence outlining problems clinical laboratories are encountering in obtaining COVID-19 supplies and requesting access to a list of state coordinators distributing supplies. On July 10, AACC joined with other healthcare groups writing to HHS requesting an extension of the COVID-19 public health emergency. On July 28th, AACC wrote to the White House Coronavirus Task Force requesting greater transparency and coordination of the distribution of laboratory supplies for COVID-19 testing. On September 21st, AACC joined with AMP in writing to HHS in support of its recent decision to require that the FDA use the rulemaking process if it wants to regulate laboratory developed tests.

On September 9th, AACC joined with other healthcare groups in writing to House and Senate appropriators urging that $41 million be allocated for newborn screening programs in fiscal year 2021.

On April 3rd, AACC joined with other healthcare groups in writing House and Senate leadership in support for additional federal funding to rebuild the public health infrastructure. On April 3rd, AACC joined with other healthcare groups in writing to the Department of Health and Human Services seeking greater access to personal protective equipment. On April 16th, AACC wrote to the White House Coronavirus Task Force requesting greater urgency in addressing COVID-19 testing supply chain issues. On April 30th, AACC wrote to the Food and Drug Administration (FDA) expressing concerns with home collection kits for COVID-19 tests. On May 16th, AACC wrote to the FDA seeking greater transparency regarding Emergency Use Authorization decisions. On May 26th, AACC joined with other healthcare groups in endorsing S.3737, the Strengthening the Public Workforce Act, which would create a loan forgiveness program for individuals willing to work in the public health community. On May 26th, AACC wrote to the Senate leadership seeking the inclusion of various provisions in a future COVID-19 package, including a more integrated testing plan, financial assistance to healthcare providers, a more coordinated system for addressing supply chain issues, rebuilding the public health infrastructure, and additional serological testing. On June 15th, AACC wrote to the White House Coronavirus Task Force urging greater federal involvement in COVID-19 testing supply chain issues. On June 18th, AACC had a conference call with HHS to express its concerns regarding the supply chain issues pertaining to COVID-19 testing. On June 26th, AACC joined with other healthcare groups in writing to Senate leaders seeking the inclusion of S.3737, the Strengthening the Public Workforce Act, in future COVID-19 legislation.

On February 28, 2020 AACC wrote to the Food and Drug Administration requesting that the agency permit laboratories develop laboratory developed tests to detect COVID-19 without having to obtain an Emergency Use Authorization from the agency. On March 25, 2020 AACC wrote to the Department of Health and Human Services requesting that pathologists and related staff be permitted to work offside during the COVID-19 pandemic under their existing CLIA lab certificate. On March 27, 2020 AACC endorsed S.3512, the Verified Innovative Testing in American Laboratories (VITAL) Act, which would codify federal regulation of laboratory developed tests under the Clinical Laboratory Improvement Amendment regulations overseen by the Centers for Medicare and Medicaid Services.

On February 20, 2020 AACC and 19 other organizations wrote to the leadership of the House and Senate Appropriation Subcommittee for Labor, Health, Education & Related Agencies seeking $7.2 million in fiscal year 2021 for the Centers for Disease Control and Prevention to expand its activities to harmonize clinical laboratory test results. On February 26, 2020 AACC joined 157 other groups in writing to the House and Senate Appropriation Subcommittee for Labor, Health, Education & Related Agencies seeking an allocation of $8.3 billion in fiscal year 2021 for the Centers for Disease Control and Prevention. On February 27, 2020 AACC joined 28 other organizations in writing to the leadership of the House and Senate Appropriation Subcommittee for Labor, Health, Education & Related Agencies seeking $10 million in fiscal year 2021 for the Centers for Disease Control and Prevention to improve pediatric reference intervals. On March 13, 2020 AACC joined with other groups in recommending that the House and Senate Appropriation Subcommittee for Labor, Health, Education & Related Agencies allocate $189 in the fiscal year 2021 budget for the National Center for Health Statistics. On March 30, 2020 AACC joined with other organizations in writing to the House and Senate Appropriations Committees recommending that funding be included in the fiscal 2021 budget to conduct an assessment of the federal response to the COVID-19 pandemic.

On December 2, 2019, AACC joined with other members of the healthcare community in writing to the House and Senate in support of H.R.3584, the Laboratory Access for Beneficiaries (LAB) Act, which would delay the reporting of lab financial data for one year and require the Medicare Payment Advisory Committee (MedPAC) to conduced a study on the payment methodology used by the Centers for Medicare Services for reimbursing clinical laboratories. On December 5, 2019, AACC met with House and Senate lawmakers and staff in support of H.R.3584, the LAB Act. On December 11 & 18, 2019, AACC conducted a grassroots campaign targeted towards House and Senate members in support of H.R.3584. On October 3, 2019, AACC conducted a congressional briefing on point of care testing for House and Senate congressional staff. The association urged the congressional offices to request the Department of Health and Human Services Office of the Inspector General to conduct a study on the quality of testing provided by Certificate of Waiver testing sites under the Clinical Laboratory Improvement Amendments and make recommendations for improvement.

On July 19, AACC, along with its partner groups, wrote to key members on the Senate Labor Health and Human Services Education and Related Agencies Subcommittee in support of providing the Centers for Disease Control and Prevention with an additional $10 million in FY20 for improving the quality of pediatric reference intervals. On July 25, 2019 AACC wrote to key members on the Senate Appropriations Committee seeking their support for providing the Centers for Disease Control with an additional $4 million for the harmonization of clinical laboratory test results, which was included in H.R.2740, the Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020.

On July 10, 2019 AACC wrote to Rep. Scott Peters endorsing H.R.3584, the Laboratory Access for Beneficiaries Act, which seeks to ensure that the payment amounts on the new market-based clinical laboratory fee schedule, authorized under the Protecting Access to Medicare Act (PAMA), are accurate. On August 20, 2019 ACC wrote to Rep. Judy Chu endorsing H.R.3031, which would reauthorize the National Quality Forum (NQF) through 2024 at $30 million annually.

On June 5, 2019 AACC members met with House and Senate congressional staff in support of providing the Centers for Disease Control and Prevention with an additional $10 million in FY20 for improving the quality of pediatric reference intervals. On June 5, 2019 AACC members met with House congressional staff in support of providing the Centers for Disease Control with an additional $4 million for the harmonization of clinical laboratory test results, which was included in H.R.2740, the Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020. On June 11, 2019 AACC joined with the CDC Coalition in writing to Senators in support for the spending amount of the overall spending level allocated to the Centers for Disease Control and Prevention in H.R.2740, the Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020, which was passed by the House of Representatives.

On February 6, 2019 AACC joined with other groups in writing to the Labor HHS Appropriation subcommittees seeking $7.2 in additional funding for CDC in FY2020 to work on harmonizing clinical laboratory test results. On March 14, 2019 AACC joined with other groups in writing to the Labor HHS Appropriations subcommittees seeking $10 million in additional funding for CDC in FY2020 to develop better pediatric reference intervals. The association also conducted a February 27, 2019 congressional briefing on the topic and met with congressional staff. On March 15, 2019 AACC joined with other groups in writing to House and Senate appropriators in opposing cuts in National Center for Health Statistics spending for FY2020.

On January 31, 2019 AACC joined with other groups in writing to the Centers for Medicare and Medicaid Services regarding Pub 100-03 Medicare National Coverage Determination. The groups were concerned that the document would limit patient access to medically necessary and relevant testing of germline mutations in cancer patients. On March 17, 2019 AACC joined with other groups in writing to CMS regarding concerns pertaining to updates to the National Correct Coding Initiative Policy Manual for Medicaid Services that took effect on January 1, 2019. The groups requested that CMS withdraw a number of recommendations pertaining to how clinical laboratories report test procedures for payment purposes.

AACC met with House and Senate staff to discuss the creation of a new program within the Centers for Disease Control and Prevention to improve the quality of pediatric reference intervals. AACC developed and published a position statement that will be used to urge legislators and CMS to expand federal oversight of certificate of waiver laboratories under the Clinical Laboratory Improvement Amendments.

AACC met with congressional staff urging legislative action to correct a problem with how the Centers for Medicare and Medicaid Services is implementing Section 216 of the Protecting Access to Medicare Act. AACC is concerned that the agency did not gather financial data from a sufficient number of laboratories, which resulted in lower than expected payment rates. AACC also conducted a grassroots campaign urging its members to contact their legislators in support of legislative action to require CMS to gather more 'representative' payment data and to streamline the process for submitting the data.

AACC join with other healthcare entities in writing to legislators in the House and Senate seeking legislative action to correct a problem with how the Centers for Medicare and Medicaid Services is implementing Section 216 of the Protecting Access to Medicare Act. Our groups are concerned that the agency did not gather financial data from a sufficient number of laboratories, which resulted in lower than expected payment rates. AACC also conducted a grassroots campaign urging its members to contact their legislators in support of legislative action to require CMS to gather more 'representative' payment data and to streamline the process for submitting the data.

AACC joined with other healthcare entities in writing to House and Senate leaders seeking $35.8 million in FY19 for the newborn screening programs within the Centers for Disease Control and Prevention and the Health Resources and Services Administration.

AACC joined with other healthcare entities in writing to House and Senate leaders seeking $35.8 million in FY19 for the newborn screening programs within the Centers for Disease Control and Prevention and the Health Resources and Services Administration.

AACC join with other healthcare entities in writing to legislators in the House and Senate seeking legislative action to correct a problem with how the Centers for Medicare and Medicaid Services is implementing Section 216 of the Protecting Access to Medicare Act. Our groups are concerned that the agency did not gather financial data from a sufficient number of laboratories, which resulted in lower than expected payment rates. AACC also conducted a grassroots campaign urging its members to contact their legislators in support of legislative action to require CMS to gather more 'representative' payment data and to streamline the process for submitting the data.

AACC joined with other healthcare entities in writing to House and Senate leaders seeking an increase of $12 million in federal funding in FY19 for newborn screening programs within the Centers for Disease Control and Prevention and the Health Resources and Services Administration. This would bring their spending levels to $42.55 million. AACC joined with the Friends of the National Center for Health Statistics in writing House and Senate leaders in seeking an increase of $15 million for NCHS in FY19. This would raise the Center's budget to $175 million.

AACC met with House and Senate legislators and congressional staff to request legislative action to correct a problem with how the Centers for Medicare and Medicaid Services is implementing Section 216 of the Protecting Access to Medicare Act. AACC is concerned that the agency did not gather financial data from a sufficient number of laboratories, which resulted in lower than expected payment rates.

AACC met with staff from the Centers for Disease Control and Prevention to discuss the creation of a new program to improve the quality of pediatric reference intervals.

AACC and its partners wrote to key House and Senate appropriators seeking a $9.2 million increase in federal funding for the Centers for Disease Control Environmental Health Laboratory to harmonize clinical laboratory test results.

AACC joined with other healthcare groups in writing to the Administrator of the Centers for Medicare and Medicaid Services requesting that the agency notify state Medicaid agencies of the recent federal cuts in the clinical laboratory fee schedule (as a result of Section 216 of the Protecting Access to Medicare Act) and how additional state rate reductions in lab fees could adversely affect patient access to testing services.

AACC met with legislators and congressional staff, sent letters, initiated several grassroots campaigns, and joined with other healthcare groups in urging that the Centers for Medicare and Medicaid Services revise its new proposed clinical laboratory fee schedule to include more payment data from a greater cross-section of the laboratory community. CMS was required to revise the CLFS to reflect private sector payment rates under Section 216 of the Protecting Access to Medicare Act.

AACC met with House and Senate legislators and staff to urge that Congress increase spending to the Centers for Disease Control Environmental Health Laboratory by $9.2 million to fund agency efforts to harmonize clinical laboratory test results.

AACC joined with the March of Dimes and other healthcare groups in writing to House and Senate appropriators opposing proposed Administration cuts in HRSA and CDC newborn screening programs for FY'18.

AACC met with House and Senate members and staff to express concerns about legislative efforts to extend Food and Drug Administration oversight to laboratory developed tests, which are currently regulated by the Centers for Medicare and Medicaid Services under CLIA'88.

AACC wrote to Senator Johnny Isakson endorsing S.794, the Local Coverage Determination Clarification Act of 2017, whioh would make the Medicare local coverage determination decision-making process more transparent.

AACC joined with other healthcare providers in writing to House and Senate Appropriators in seeking FY18 federal funding to combat the Zika virus. AACC joined with the March of Dimes and other healthcare groups in writing to House and Senate Appropriators supporting federal funding for federal newborn screening programs for FY 17. AACC joined with the Friends of AHRQ in writing House and Senate Appropriators seeking federal funding for the Agency for Healthcare Research and Quality in FY17. AACC joined with other healthcare groups in writing to House and Senate Appropriators seeking additional federal funding for CDC in FY18 to harmonize clinical laboratory test results.

AACC wrote to Rep. Phil Roe, MD, endorsing H.R.849, the Protecting Seniors' Access to Medicare Act of 2017, which would eliminate the Independent Payment Advisory Board created by the Affordable Care Act of 2010. AACC also endorsed the companion bill, S.260, introduced by Senator John Cornyn in the Senate.

AACC endorsed H.R.6283, the Truth in Regulations Act of 2016, which would increase the administrative requirements on agencies using guidance in lieu of rulemaking.

AACC conducted a congressional briefing for House and Senate staff to educate them about the need for harmonizing clinical laboratory test results.

AACC contacted Senate HELP leaders to urge that the CLIA amendments be modernized to address concerns regarding oversight of laboratory developed tests rather than expanding Food and Drug Administration oversight of the tests.

AACC and a number of other healthcare groups wrote to key House and Senate Leaders and Leaders on the House and Senate appropriators in support of report language accompanying the FY 2017 House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Bill that requires the Centers for Disease Control and Prevention to describe its ongoing and future efforts to harmonize clinical laboratory test results.

AACC joined with the March of Dimes and other healthcare groups in urging House and Senate leaders to provide emergency supplemental funding to assist federal agencies deal with the Zika virus in the United States. AACC and a number of other healthcare groups wrote to House and Senate appropriators seeking an additional $9.2 million for the Centers for Disease Control and Prevention Environmental Health Laboratory in the fiscal year 2017 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Bill to harmonize clinical laboratory test results. AACC also met with congressional staff to discuss this issue. AACC wrote to House leaders supporting the inclusion of report language in the Labor HHS Education and Related Agencies appropriations bill that directs the FDA to stop work on the laboratory developed test guidance until Congress takes action.

AACC contacted Senate leaders in support of an amendment included in S.2700, the FDA and NIH Workforce Authorities Modernization Act, which would require the FDA to explain its rationale for choosing to set policy via guidance rather that the ulemaking process. AACC contacted the Centers for Medicare and Medicaid Services and requested that the agency suspend a provision in Memorandum S&C 16-18-CLIA, which grants equivalency to nursing degrees for the purposes of qualifying nurses as high and moderate complexity healthcare personnel. The Association suggested that such changes should have been considered through the rulemaking process. AACC met with congressional staff in support of maintaining CLIA'88 oversight of laboratory developed tests.

AACC joined with the Friends of AHRQ in writing legislators in support of increasing funding for AHRQ in the fiscal year 2017 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Bill. AACC joined with the March of Dimes and other healthcare groups in urging House and Senate leaders to provide emergency supplemental funding to assist federal agencies deal with the Zika virus in the United States. AACC and a number of other healthcare groups wrote to House and Senate appropriators seeking an additional $9.2 million for the Centers for Disease Control and Prevention Environmental Health Laboratory in the fiscal year 2017 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Bill to harmonize clinical laboratory test results.

Harmonization of Clinical Laboratory Tests -- AACC and its representatives met with and educated congressional staff about the need to provide additional federal funding to the Centers for Disease Control and Prevention to harmonize clinical laboratory test results. AACC and its representatives met with and educated congressional staff about its concerns with ongoing efforts to expand Food and Drug Administration oversight to laboratory developed tests. AACC asserted that the existing regulatory structure should be maintained and that the Centers for Medicare and Medicaid Services should remain the primary oversight body of LDTs. Direct-to-Consumer Testing -- AACC and its representatives educated congressional staff about the expanded use of DTC testing and the need for agencies to ensure that testing facilities performing such tests comply with federal quality and marketing practices. In addition, AACC recommended that FDA and CMS establish requirements mandating that DTC providers disclose sufficient information about their products and services to consumers. Precision Medicine - AACC and its representatives educated congressional staff on the value of personalized medicine in improving patient care. AACC recommended that Congress urge government agencies to streamline regulations that hinder the development of this promising field and ensure that such tests are adequately reimbursed.

AACC joined with other healthcare groups in supporting funding for the National Children's Study Alternative, which is included in both the Senate (S.1695) and House (H.R.3020), Labor, HHS, Education, and Related Agencies Appropriations bills under the National Institutes of Health Office of the Director. AACC joined with the Friends of AHRQ, and separately, in writing legislators opposing elimination of AHRQ funding in H.R. 3020, the 2016 Labor, HHS, Education and Related Agencies Appropriations bill.

AACC met with Centers for Disease and Prevention staff to discuss funding for the harmonization of clinical laboratory test results. The Accompanying Language to the Consolidated and Further Continuing Appropriations Act of 2015 included a recommendation that CDC work with the private sector in promoting harmonization.

AACC endorsed H.R.1190, the "Protecting Seniors' Access to Medicare Act of 2015", which would eliminate the Independent Payment Advisory Board (IPAB) created by the Affordable Care Act (ACA) of 2010. This Board is empowered to make cuts in Medicare reimbursement without congressional authorization.

AACC contacted House and Senate staff and legislators to express concerns about ongoing efforts to expand Food and Drug Administration oversight to laboratory developed tests. Currently LDTs are regulated by the Centers for Medicare and Medicaid Services. AACC also contacted House and Senate staff and legislators to discuss the harmonization of clinical laboratory test results. The Accompanying Language to the Consolidated and Further Continuing Appropriations Act of 2015 included a recommendation under the Centers for Disease Control Prevention Environmental Health section that encourages CDC to work with the private sector in promoting harmonization. AACC mentioned its intent to develop and circulate a legislative proposal to satisfy that recommendation. AACC also expressed its support for federal efforts to advance personalized medicine with House, Senate and White House personnel.

AACC joined with the Friends of AHRQ in recommending that Congress appropriate $375 million in budget authority in fiscal year 2016. AHRQ is one of the leading federal agencies in comparative effectiveness research and patient safety.

AACC endorsed H.R.260, the Protect Medical Innovation Act, and S.149, the Medical Device Access and Innovation Act. Each bill would repeal the 2.3 percent excise tax imposed on medical devices as part of the 2010 Affordable Care Act.

AACC endorsed S.141, the Protecting Seniors' Access to Medicare Act, which would eliminate the Independent Payment Advisory board created by the Affordable Care Act of 2010.

AACC endorsed S.141, the Protecting Seniors' Access to Medicare Act, which would eliminate the Independent Payment Advisory board created by the Affordable Care Act of 2010.

AACC wrote to House and Senate Appropriators endorsing the President's Precision Medicine Initiative, which would provide $215 million to establish more effective treatment options for cancer patients and establish a voluntary national research cohort of health data for better assessing disease risk.

AACC contacted House and Senate offices in support of H.R.1281, the Newborn Screening Saves Lives Reauthorization Act, which would continue the current federal-state partnership ensuring that babies are tested for certain metabolic conditions. The Association also held a congressional briefing for legislative staff focusing on the need for enacting this legislation.

AACC joined with other health care groups in meeting with Health Resources and Services Administration staff to discuss funding opportunities for allied health grant programs.

AACC joined with other health care groups in writing to the Health Resources and Services Administration in support of creating an office for allied health and laboratory medicine professions.

AACC contacted House and Senate offices in support of getting report language included in the Labor, HHS, Education and Related Agences appropriations bills recognizing the need to harmonize clinical laboratory test results.

AACC contacted congressional offices urging support of H.R.1281 and S.1417, the Newborn Screening Saves Lives Reauthorization Act

AACC contacted the Centers for Medicare and Medicaid Services regarding H.R.4302, the Protecting Access to Medicare Act of 2014, regarding Section 216, which requires the Agency to modify the Clinical Laboratory Fee Schedule so that laboratory test payments reflect private market based rates. The Association urged CMS to do a preliminary impact analysis study to determine what affect the new market rates may have on beneficiary access to care and the laboratory market.

AACC joined with the Friends of AHRQ in supporting increased federal funding for the Agency for Healthcare Research and Quality.

AACC has written and contacted House and Senate offices in support of getting report language in the Labor, HHS, Education and Related Agencies appropriations bills recognizing the need for the harmonization of clinical laboratory test results.

AACC contacted House and Senate legislators opposing a provision in the President's FY'2015 budget extending a provision from the Affordable Care Act that cuts the laboratory consumer price index by 1.75 percent through 2015. The President's proposal would extend this cut through 2023.

AACC wrote Senators Orrin Hatch (R-UT) and Kay Hagan (D-NC) endorsing their legislation S.1417, the Newborn Screening Saves Lives Reauthorization Act of 2013.

* AACC joined with other laboratory groups in writing to the HHS OIG raising concerns regarding the findings of a June 2013 OIG report on laboratory reimbursement. *AACC joined with other laboratory groups in writing to CMS in opposition to proposed cuts in pathology reimbursement rates outlined in the July 19, 2013 Physician Fee Schedule for CY 2014

* AACC joined with other laboratory groups in writing to the HHS OIG raising concerns regarding the findings of a June 2013 OIG report on laboratory reimbursement. * AACC joined with other laboratory groups in writing to CMS in opposition to proposed cuts in pathology reimbursement rates outlined in the July 19, 2013 Physician Fee Schedule for CY 2014

AACC wrote Senators Orrin Hatch (R-UT) and Kay Hagan (D-NC) endorsing their legislation S.1417, the Newborn Screening Saves Lives Reauthorization Act of 2013.

AACC endorsed a provision of S.1284, the Department of Labor, Health and Human Services, and Education, and Related Agencies Appropriations bill. The provision was located within the Centers for Disease Control and Prevention, Environmental Health sections. The provision would provide CDC with funding to standardize chronic disease markers.

AACC urged its members to write to Congress to oppose additional cuts in laboratory reimbursement.

* AACC joined with other laboratory groups in writing to the HHS OIG raising concerns regarding the findings of a June 2013 OIG report on laboratory reimbursement. * AACC joined with other laboratory groups in writing to CMS in opposition to proposed cuts in pathology reimbursement rates outlined in the July 19, 2010 Physician Feee Schedule Proposed Rule for CY 2014.

AACC wrote Senators Orrin Hatch (R-UT) and Kay Hagan (D-NC) endorsing their legislation S.1417, the Newborn Screening Saves Lives Reauthorization Act of 2013.

AACC joined with other organizations on a joint letter to Senate members opposing Senate Amendment 67 to the Continuing Resolution, H.R.933, which would have limited the number of government employees who could attend any meeting or conference to 25.

* AACC wrote to House and Senate leaders opposing a provision in the President's 2014 proposed federal budget that would extend a 1.75 percent cut in the annual laboratory consumer price index throught 2023.

* AACC wrote key House members endorsing H.R.1281, the Newborn Screening Saves Lives Reauthorization Act of 2013.

* AACC wrote to key legislators opposing additional cuts in Medicare reimbursement for clinical laboratories. * AACC wrote to key legislators opposing the establishment of a Medicare beneficiary copayment for clinical laboratory services.

*AACC wrote letters endorsing H.R.523, the Protect Medical Innovation Act, and S. 232, the Medical Device Access and Innovation Protection Act, which would repeal the 2.3 percent medical device excise tax imposed on medical device manufacturers as part of the Affordable Care Act (Section 9009).

AACC joined the Clinical Laboratory Coalition in writing to Members of Congress in opposition to additional Medicare cuts in laboratory reimbursement

AACC is working to 'harmonize' test results generated by different medical devices. This initiative would result in uniform reportable test values for clinical interpretation regardless of device. Medical device manufacturers are concerned changes in test reporting would require them to submit them to new a 510(k). AACC recommended that FDA not require a new 510(k) when a change to the device only alters the understanding of the result, not the actual result itself.

AACC wrote to House Appropriations members opposing a provision of the draft FY'13 Labor, Health and Human Services, Education, and Related Agencies bill (Title II, Department of Health and Human Services, Section 227(a)), which eliminated funding for the Agency for Healthcare Research and Quality.

AACC endorsed S.3391 & H.R.6118, the "Taking Essential Steps for Testing Act," which would modify the Clinical Laboratory Improvement Amendments of 1988 to give the Centers for Medicare and Medicaid Services greater latitude in determining what penalties it could impose on laboratories that referred a proficiency testing specimen to an outside laboratory for analysis.

AACC joined with other groups in urging House and Senate members to amend Title 18 of the Social Security Act to classify appropriately qualified doctoral scientists as Qualified Health Care Practitioners, eligible to be paid by Medicare directly for their professional interpretative services for molecular pathology.

AACC contacted House leaders to support provisions Sections 721 and 203(f) of H.R.5651, Food and Drug Administration Reform Act of 2012, which sought to streamline the FDA de novo medical device review process and give the HHS Secretary authority to waive FDA medical device user fees in the interest of public health.

AACC joined with the Friends of AHRQ Coalition in recommending that House and Senate legislators increase funding for the Agency for Healthcare Research and Quality in the FY'13 Labor, Health and Human Services, Education and Related Agencies Appropriations bill.

AACC joined with Association of American Publishers and DC Principles Coalition in writing to Congress in opposition to the Federal Research Public Access Act (S.2096 & H.R.4004), which would require the final manuscripts of peer-reviewed, private-sector journal articles authored by federally-funded researchers to be made freely available to the world through federal agency web sites no later than six months after their publication in journals.

AACC joined with other laboratory and health care groups in writing House and Senate leaders urging them to extend a provision in the law that was to expire December 31, 2011, which allowed independent laboratories to bill Medicare directly for the technical component of pathology services provided to hospitals.

AACC joined with Members of the Clinical Laboratory Coalition in writing to Members of the House and Senate in opposing the adoption of a clinical laboratory co-payment as part of any debt reduction package. AACC joined with Members of the Clinical Laboratory Coalition in writing to members of the Joint Select Committee on Deficit Reduction in opposition to a clinical laboratory co-payment as part of any debt reduction package. AACC wrote separately to House and Senate Members of the Joint Select Committee on Deficit Reduction to oppose the establishment of a clinical laboratory co-payment as part of any debt reduction package.

AACC wrote to House and Senate legislators in opposition to efforts to establish a laboratory co-payment for Medicare services.

AACC joined with the Friends of AHRQ Coalition in recommending that House and Senate legislators increase funding for the Agency for Healthcare Research and Quality in the FY2012 Labor, Health and Human Services, Education, and Related Agencies Appropriations Bill.

AACC endorsed H.R.4, the Small Business Paperwork Mandate Elimination Act of 2011, which would repeal Section 9006 of the Patient Protection and Affordable Care Act of 2010. This provision would require employers to issue an IRS form 1099 to all their vendors that receive payments in excess of $600 annually.

AACC wrote to House and Senate appropriators urging full funding for the NIH National Children's Study in the forthcoming fiscal year 2012 Department of Labor, Health and Human Services, and Education and Related Agencies Appropriations Bill.

AACC joined with other laboratory and health care groups in writing to CMS in opposition to a provision of the November 29, 2010 Medicare Physician Fee Schedule Final Rule [Section 3104: Extension of Payment for Technical Component of Certain Physician Pathology Services] that requires a physician's or qualified non physician practitioner's signature on all requisitions for clinical diagnostic laboratory tests paid for on the basis of the Clinical Laboratory Fee Schedule.

AACC joined with other organizations in supporting repeal of Sec. 9006. Expansion of information reporting requirements, of P.L. 111-148.

AACC joined with the DC Principles Coalition in opposing H.R.5037, the Federal Research Public Access Act, which would require that final manuscripts of peer-reviewed, private sector journal articles reporting on federally-funded reseach be made freely available on government-run websites no later than six months after publication.

H.R.3962, the Affordable Health Care for America Act; Division B - Medicare and Medicaid Improvements; Title I - Improving Health Care Value; Subtitle B - Provisions Related to Part B; Part 2 - Market Basket Updates; Section 1131, Incorporating Productivity Improvements into Market Basket Updates that do not already incorporate such improvements; (d) Laboratory Services. AACC joined with Clinical Laboratory Coalition in writing to House legislators urging them to amend (cont. on next page)

AACC joined with other health care groups in writing House and Senate leaders urging them to extend a provision in the law that expired on December 31, 2009, which allowed independent laboratories to bill Medicare directly for the technical component of pathology services provided to hospital patients.

S.1679, the Affordable Health Choices Act, Title II, Improving the Quality and Efficiency of Health Care, Subtitle B, Section 219, Center for Health Outcomes Research and Evaluation, Section 937, Center for Health Outcomes Research and Evaluation. AACC joined with other health care organizations in sending a coalition letter to Senate legislators in support of retaining AHRQ as the leading federal agency responsible for comparative effectiveness research.

S.1213, the Patient-Centered Outcomes Research Act of 2009. AACC wrote legislators expressing support for the measure, which would increase federal funding for comparative effectiveness reseach. S. 1679, the Affordable Health Choices Act, Title II, Improving the Quality and Efficiency of Health Care, Subtitle B, Section 219, Center for Health Outcomes Research and Evaluation, Section 937, Center for Health Outcomes Research and Evaluation. AACC wrote to the Senate Health Education Labor and Pensions Committee and contacted Senate staff to express support for retaining the Agency for Healthcare Research and Quality as the leading federal agency responsible for comparative effectiveness research. S. 1679, the Affordable Health Choices Act, Title II, Improving the Quality and Efficiency of Health Care, Subtitle B, Section 219, Center for Health Outcomes Research and Evaluation, Section 937, Center for Health Outcomes Research and Evaluation. AACC joined with other health care organizations in sending a coalition letter to Senate legislators in support of retaining AHRQ as the leading federal agency responsible for comparative effectiveness research. H.R. 3200, America's Affordable Health Choices Act, Division A, Title IV Quality, Section A Comparative Effectiveness Research Section 1401. AACC joined with other health care organizations in sending a coalition letter to House legislators in support of retaining AHRQ as the leading federal agency responsible for comparative effectiveness research.

AACC wrote to the Agency for Healthcare Research and Quality recommending priority research areas for how the $300 million it received for comparative effectiveness under S.1, the American Recovery and Reinvestment Act of 2009, Title VIII, HHS, AHRQ, Health Research and Quality, should be allocated

AACC, separately, as as part of the Clinical Laboratory Coalition, sent letters to key House, Senate and White House health leaders outlining principles for health care reform.

FY'10 Appropriations, Agency for Healthcare Research and Quality. AACC joined the Friends of AHRQ in recommending an increase in AHRQ funding.

AACC met with Senate staff, as part of the Personalized Medicine Coalition, to discuss comparative effectiveness legislation.

AACC requested that NIH continue to provide funding for the Centers for Disease Control and Prevention's Lipid Standardization Program, which standardizes assays that assist health care providers make more informed decisions.

Met with HHS staff as part of coalition to discuss with Secretary's Advisory Committee on Genetics, Health and Society in regards to recommendations regarding government oversight of laboratory developed tests and a registry of laboratory tests. The group raised concerns and questions about the two issues.

S.3101, the Medicare Improvements for Patients and Providers Act of 2008, Sections 101 and 146. Section 101 allows HHS to add new preventive services without congressional approval. Section 146 repeals CMS' authority to conduct a competitive bidding demonstration project for clinical laboratory services. AACC wrote legislators in support of Sections 101 and 146. AACC joined a coalition in support of Section 146. AACC also urged its members to contact their Senators in favor of Section 146.

Department of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act of 2009, Title II, HHS, NIH, Office of Director. AACC urged its members to contact House and Senate legislators in support of funding for the NIH National Children's Study

H.R.3800, the Wired for Health Care Quality Act. AACC wrote letter endorsing the legislation.

AACC, as a member of the Friends of AHRQ, recommended that Appropriators increase FY'09 funding for the Agency for Healthcare Research and Quality. AACC, as a member of the Friends of the National Center for Health Statistics, recommended that Appropriators increase FY'09 funding for the Center.

P.L.108-173, H.R.1, Section 302, Medicare Prescription Drug, Improvement and Modernization Act of 2003, requires a competitive bidding demonstration project for laboratory services. AACC endorsed legislation, H.R.3453 and S.2099, which would repeal Section 302 and thereby bar CMS from conducting the competitive bidding demonstration project.

H.R.3043 (Section 218), S.1710 (Section 221), Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2008. AACC opposed these provisions, which required NIH funded investigators to submit to PubMed Central an electronic version of their final, peer-reviewed manuscripts no later than 12 months after the official date of publication.

1. AACC endorsed H.R.1501, the Medicare Laboratory Services Access Act of 2007, which would increase the fee Medicare pays health care providers for collecting patient specimens.

1. AACC endorsed S.224 and H.R.325, the Standards to Provide Educational Achievement for Kids Act, which would develop and promote voluntary math and science educational standards for studnents from kindergarten through grade 12.

2. H.R.3043, S.1710, Departs. of Labor, Health and Human Services, and Education, and Related Agencies Approp. Act of 2008, Title II, HHS, AHRQ. AACC joined with the Friends of AHRQ coalition in writing in support of increased funding for AHRQ research studies. 3. H.R.3043, S.1710, Departs. of Labor, Health and Human Services, and Education, and Related Agencies Approp. Act of 2008, Title II, HHS, CDC. AACC joined with the Friends of the National Center for Health Statistics coalition in support of increased funding NCHS activities. 1. H.R.3043, S.1710, Departs. of Labor, Health and Human Services, and Education, and Related Agencies Approp. Act of 2008, Title II, HHS, NIH, Office of the Director. AACC wrote to legislators in support of funding for the NIH National Children's study.

1. AACC endorsed H.R.1501, the Medicare Laboratory Services Access Act of 2007, which would increase the fee Medicare pays health care providers for collecting patient specimens.

2. H.R.3043, S.1710, Departs. of Labor, Health and Human Services, and Education, and Related Agencies Approp. Act of 2008, Title II, HHS, AHRQ. AACC joined with the Friends of AHRQ coalition in writing in support of increased funding for AHRQ research studies. 3. H.R.3043, S.1710, Departs. of Labor, Health and Human Services, and Education, and Related Agencies Approp. Act of 2008, Title II, HHS, CDC. AACC joined with the Friends of the National Center for Health Statistics coalition in support of increased funding NCHS activities. 1. H.R.3043, S.1710, Departs. of Labor, Health and Human Services, and Education, and Related Agencies Approp. Act of 2008, Title II, HHS, NIH, Office of the Director. AACC wrote to legislators in support of funding for the NIH National Children's study.

H.R.5647, S.3708, Departs. of Labor, Health and Human Services, and Education, and Related Agencies Approp. Act of 2007, Title II, HHS, NIH. AACC urged its members to write their legislators in support of funding for the NIH National Children's Study.

PL 108-173, H.R.1, Section 302, Medicare Prescription Drug, Improvement and Modernization Act of 2003, requires a competitive bidding demonstration project for laboratory services. AACC worked with other laboratory groups to urge a more open decision-making process.

ADLM is interested in a variety of appropriations, research, regulatory, & payment issues affecting laboratory medicine.

ADLM is interested in a variety of appropriations, research, regulatory, & payment issues affecting laboratory medicine.