Pediatricians Accelerate Childhood Therapies Act of 2023

Boston Children's Hospital advocates for medical research funding generally (eg NIH) and to assure an emphasis on pediatric research issues and concerns. In the current Congress, we have sought increases in the overall NIH appropriation level, and worked to assure better coordination across NIH institutes for pediatric initiatives. We have focused on the need to provide additional support for early career pediatric researchers through the planned reintroduction of the Pediatricians Accelerate Childhood Therapies (PACT) Act (S. 2345, H.R. 4714); inclusion of children within the All of Us research program, ARPA-H, and the 21st Century Cures 2.0. Our informatics research program has provided information on disease surveillance/pandemic preparedness, health IT and interoperability concerns to Congressional leaders.

Client expense: $80,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

S. 2345 and H.R. 4714, the Pediatricians Accelerate Childhood Therapies Act; Issues pertaining to recruitment and enrollment of children within the All of Us program; NIH reform modernization; Inclusion of child health activities within ARPA-H portfolio; Proposed changes to NICHD career development programs; National Academy assessment of NIH pediatric research activities.

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

Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

S 765/HR 1526: Reducing Hereditary Cancer Act of 2023- provide hereditary cancer genetic testing Increasing access to telehealth S 2016/HR 4189: CONNECT for Health Act- expands access to telehealth services Medicare physician payment reforms HR 2474: Strengthening Medicare for Patients and Providers Act- physician reimbursement HR 5013: Value in Health Care Act of 2023 - provides a multi-year commitment to reforming care delivery by extending MACRA's 5 percent advanced APM incentives for an additional two years. S 3503: Value in Health Care Act of 2023 - A bill to direct the Secretary of Health and Human Services to revise certain regulations in relation to the Medicare shared savings program and other alternative payment arrangements to encourage participation in such program, and for other purposes HR 6371: Provider Reimbursement Stability Act of 2023 - To provide for certain adjustments to the physician fee schedule under the Medicare program. H.R. 6369: To amend title XVIII of the Social Security Act to extend incentive payments for participation in eligible alternative payment models - Extend incentive payments for participation in alternative payment models HR 3674: Providing Relief and Stability for Medicare Patients Act of 2023 - increase the nonfacility practice expense relative value units for specified services furnished under the Medicare program Reducing burdens caused by prior authorization requirements HR 4968: GOLD CARD Act of 2023 - exempt qualifying providers from prior authorization requirements under Medicare Advantage plans S 2372/HR 4758: Accelerating Kids' Access to Care Act - improve childrens access to needed out-of-state health care by streamlining Medicaid provider screening and enrollment processes. HR 6364: Medicare Telehealth Privacy Act of 2023 - To amend title XVIII of the Social Security Act to maintain certain telehealth flexibilities relating to provider privacy under the Medicare program S 2764/HR 5391: Protecting Patient Access to Cancer and Complex Therapies Act of 2023 - ensures patients will be able to access critical medications and providers will be reimbursed fairly, unaffected by drug pricing negotiations between Medicare and drug manufacturers. S 2345/HR 4714: Pediatricians Accelerate Childhood Therapies Act of 2023 - requires the National Institutes of Health (NIH) to make awards to support early-career pediatric researchers. It also provides statutory authority for the NIH Pediatric Research Consortium to coordinate pediatric research across national health research institutions. S 3967/HR 7623: Telehealth Modernization Act of 2024 - permanently extends telehealth flexibilities for Medicare beneficiaries. S 4518/HR 8702: To Amend title XVIII of the Social Security Act to establish requirements with respect to the use of prior authorization under Medicare Advantage plans - prior authorization HR 7384: Creating Hope Reauthorization Act of 2024 - This bill extends until FY2029 a Food and Drug Administration program that awards priority review vouchers to manufacturers of drugs that treat rare pediatric diseases. HR 8412: Clinical Trial Modernization Act - To modernize clinical trials and remove barriers for participation in clinical trials, and for other purposes. S 2407/HR 4818: Treat and Reduce Obesity Act of 2023 - Expands Medicare coverage of intensive behavioral therapy for obesity. HR 6545: Physician Fee Schedule Update and Improvements Act - To amend title XVIII of the Social Security Act to make improvements to the physician fee schedule under the Medicare program. HR 6683: Preserving Seniors' Access to Physicians Act of 2023 - This bill increases payments under the Medicare physician fee schedule for 2024. S 4935: Physician Fee Stabilization Act - A bill to amend title XVIII of the Social Security Act to update the budget neutrality threshold under the Medicare physician fee schedule.

S. 2345 and H.R. 4714, the Pediatricians Accelerate Childhood Therapies Act; Issues pertaining to recruitment and enrollment of children within the All of Us program; NIH reform modernization; Inclusion of child health activities within ARPA-H portfolio; Proposed changes to NICHD career development programs.

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

Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

S 765/HR 1526: Reducing Hereditary Cancer Act of 2023- provide hereditary cancer genetic testing Increasing access to telehealth S 2016/HR 4189: CONNECT for Health Act- expands access to telehealth services Medicare physician payment reforms HR 2474: Strengthening Medicare for Patients and Providers Act- physician reimbursement HR 5013: Value in Health Care Act of 2023 - provides a multi-year commitment to reforming care delivery by extending MACRA's 5 percent advanced APM incentives for an additional two years. S 3503: Value in Health Care Act of 2023 - A bill to direct the Secretary of Health and Human Services to revise certain regulations in relation to the Medicare shared savings program and other alternative payment arrangements to encourage participation in such program, and for other purposes HR 6371: Provider Reimbursement Stability Act of 2023 - To provide for certain adjustments to the physician fee schedule under the Medicare program. H.R. 6369: To amend title XVIII of the Social Security Act to extend incentive payments for participation in eligible alternative payment models - Extend incentive payments for participation in alternative payment models HR 3674: Providing Relief and Stability for Medicare Patients Act of 2023 - increase the nonfacility practice expense relative value units for specified services furnished under the Medicare program Reducing burdens caused by prior authorization requirements HR 4968: GOLD CARD Act of 2023 - exempt qualifying providers from prior authorization requirements under Medicare Advantage plans S 2372/HR 4758: Accelerating Kids' Access to Care Act - improve childrens access to needed out-of-state health care by streamlining Medicaid provider screening and enrollment processes. HR 6364: Medicare Telehealth Privacy Act of 2023 - To amend title XVIII of the Social Security Act to maintain certain telehealth flexibilities relating to provider privacy under the Medicare program S 2764/HR 5391: Protecting Patient Access to Cancer and Complex Therapies Act of 2023 - ensures patients will be able to access critical medications and providers will be reimbursed fairly, unaffected by drug pricing negotiations between Medicare and drug manufacturers. S 2345/HR 4714: Pediatricians Accelerate Childhood Therapies Act of 2023 - requires the National Institutes of Health (NIH) to make awards to support early-career pediatric researchers. It also provides statutory authority for the NIH Pediatric Research Consortium to coordinate pediatric research across national health research institutions. S 3967/HR 7623: Telehealth Modernization Act of 2024 - permanently extends telehealth flexibilities for Medicare beneficiaries. S 4518/HR 8702: To Amend title XVIII of the Social Security Act to establish requirements with respect to the use of prior authorization under Medicare Advantage plans - prior authorization HR 7384: Creating Hope Reauthorization Act of 2024 - This bill extends until FY2029 a Food and Drug Administration program that awards priority review vouchers to manufacturers of drugs that treat rare pediatric diseases. HR 8412: Clinical Trial Modernization Act - To modernize clinical trials and remove barriers for participation in clinical trials, and for other purposes. S 2407/HR 4818: Treat and Reduce Obesity Act of 2023 - Expands Medicare coverage of intensive behavioral therapy for obesity.

H.R. 4714 & S. 2345, The Pediatricians Accelerate Childhood Therapies (PACT) Act H.R. 3226 & S.1573, The PREEMIE Reauthorization Act H.R. 3838 & S.2415, Preventing Maternal Deaths Reauthorization Act of 2023 H.R.7087 & S.3641, MOMS Who Serve Act H.R. 3312 & S. 1602, Moms Matter Act H.R. 5378, Lower Costs, More Transparency Act (hospital & 340B provisions) SUSTAIN 340B Act - Senate discussion draft H.R 7635, 340B PATIENTS Act H.R. 7808, Early Action and Responsiveness Lifts Youth (EARLY) Minds Act H.R. 2439 & S. 1135, Ally's Act H.R. 7542 & S. 3864, Stop CMV Act H.R. 7379, Patient Matching and Transparency in Certified Health IT (MATCH IT) Act H.R. 6664, Innovation in Pediatric Drug Act of 2023 H.R. 5012 & S. 2647, SHINE for Autumn Act H.R. 2412, Helping Kids Cope Act

Client expense: $190,219 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 765/HR 1526: Reducing Hereditary Cancer Act of 2023- provide hereditary cancer genetic testing Increasing access to telehealth S 2016/HR 4189: CONNECT for Health Act- expands access to telehealth services Medicare physician payment reforms HR 2474: Strengthening Medicare for Patients and Providers Act- physician reimbursement HR 5013: Value in Health Care Act of 2023 - provides a multi-year commitment to reforming care delivery by extending MACRA's 5 percent advanced APM incentives for an additional two years. S 3503: Value in Health Care Act of 2023 - A bill to direct the Secretary of Health and Human Services to revise certain regulations in relation to the Medicare shared savings program and other alternative payment arrangements to encourage participation in such program, and for other purposes HR 6371: Provider Reimbursement Stability Act of 2023 - To provide for certain adjustments to the physician fee schedule under the Medicare program. H.R. 6369: To amend title XVIII of the Social Security Act to extend incentive payments for participation in eligible alternative payment models - Extend incentive payments for participation in alternative payment models HR 3674: Providing Relief and Stability for Medicare Patients Act of 2023 - increase the nonfacility practice expense relative value units for specified services furnished under the Medicare program Reducing burdens caused by prior authorization requirements HR 4968: GOLD CARD Act of 2023 - exempt qualifying providers from prior authorization requirements under Medicare Advantage plans S 2372/HR 4758: Accelerating Kids' Access to Care Act - improve childrens access to needed out-of-state health care by streamlining Medicaid provider screening and enrollment processes. HR 6364: Medicare Telehealth Privacy Act of 2023 - To amend title XVIII of the Social Security Act to maintain certain telehealth flexibilities relating to provider privacy under the Medicare program S 2764/HR 5391: Protecting Patient Access to Cancer and Complex Therapies Act of 2023 - ensures patients will be able to access critical medications and providers will be reimbursed fairly, unaffected by drug pricing negotiations between Medicare and drug manufacturers. S 2345/HR 4714: Pediatricians Accelerate Childhood Therapies Act of 2023 - requires the National Institutes of Health (NIH) to make awards to support early-career pediatric researchers. It also provides statutory authority for the NIH Pediatric Research Consortium to coordinate pediatric research across national health research institutions. S 3967/HR 7623: Telehealth Modernization Act of 2024 - permanently extends telehealth flexibilities for Medicare beneficiaries.

S 765/HR 1526: Reducing Hereditary Cancer Act of 2023- provide hereditary cancer genetic testing Increasing access to telehealth S 2016/HR 4189: CONNECT for Health Act- expands access to telehealth services Medicare physician payment reforms HR 2474: Strengthening Medicare for Patients and Providers Act- physician reimbursement HR 5013: Value in Health Care Act of 2023 - provides a multi-year commitment to reforming care delivery by extending MACRA's 5 percent advanced APM incentives for an additional two years. S 3503: Value in Health Care Act of 2023 - A bill to direct the Secretary of Health and Human Services to revise certain regulations in relation to the Medicare shared savings program and other alternative payment arrangements to encourage participation in such program, and for other purposes HR 6371: Provider Reimbursement Stability Act of 2023 - To provide for certain adjustments to the physician fee schedule under the Medicare program. H.R. 6369: To amend title XVIII of the Social Security Act to extend incentive payments for participation in eligible alternative payment models - Extend incentive payments for participation in alternative payment models HR 3674: Providing Relief and Stability for Medicare Patients Act of 2023 - increase the nonfacility practice expense relative value units for specified services furnished under the Medicare program Reducing burdens caused by prior authorization requirements HR 4968: GOLD CARD Act of 2023 - exempt qualifying providers from prior authorization requirements under Medicare Advantage plans S 2372/HR 4758: Accelerating Kids' Access to Care Act - improve childrens access to needed out-of-state health care by streamlining Medicaid provider screening and enrollment processes. HR 6364: Medicare Telehealth Privacy Act of 2023 - To amend title XVIII of the Social Security Act to maintain certain telehealth flexibilities relating to provider privacy under the Medicare program S 2764/HR 5391: Protecting Patient Access to Cancer and Complex Therapies Act of 2023 - ensures patients will be able to access critical medications and providers will be reimbursed fairly, unaffected by drug pricing negotiations between Medicare and drug manufacturers. S 2345/HR 4714: Pediatricians Accelerate Childhood Therapies Act of 2023 - requires the National Institutes of Health (NIH) to make awards to support early-career pediatric researchers. It also provides statutory authority for the NIH Pediatric Research Consortium to coordinate pediatric research across national health research institutions. S 3967/HR 7623: Telehealth Modernization Act of 2024 - permanently extends telehealth flexibilities for Medicare beneficiaries.

S. 2345 and H.R. 4714, the Pediatricians Accelerate Childhood Therapies Act; Issues pertaining to recruitment and enrollment of children within the All of Us program; NIH reform modernization; Inclusion of child health activities within ARPA-H portfolio.

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

Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

S. 3085, Preventing Adverse Childhood Experiences (PACE) Act S. 1409, Kids Online Safety Act (KOSA) H.R. 4714 & S. 2345, The Pediatricians Accelerate Childhood Therapies (PACT) Act H.R. 3226 & S.1573, The PREEMIE Reauthorization Act H.R. 3838 & S.2415, Preventing Maternal Deaths Reauthorization Act of 2023 S. 3393, SUPPORT for Patients and Communities Reauthorization Act - advocated for inclusion of Community Mental Health Services Block Grant (MHBG) Prevention & Early Intervention Set Aside & S. 3085, PACE Act provisions in reauthorization H.R. 5378, Lower Costs, More Transparency Act (hospital & 340B provisions) H.R. 7808, Early Action and Responsiveness Lifts Youth (EARLY) Minds Act H.R. 2439 & S. 1135, Ally's Act H.R. 7379, Patient Matching and Transparency in Certified Health IT (MATCH IT) Act H.R. 6960 & S. 3765, Emergency Medical Services for Children (EMSC) Reauthorization Act of 2024 H.R. 6664, Innovation in Pediatric Drug Act of 2023 H.R. 6963, Pediatric Cancer Drug Supply Act of 2024 H.R. 3433, Give Kids a Chance Act SUSTAIN 340B Act - Senate discussion draft H.R. 4581 & S. 2231, Maternal and Child Health Stillbirth Prevention Act H.R. 5012 & S. 2647, SHINE for Autumn Act Pending telehealth legislation slated for end of 2024 H.R. 7542 & S. 3864, Stop CMV Act

Client expense: $211,059 · Firm income: Not reported

Medicaid program reforms, including telemedicine and prior authorization issues Section 340B Drug Pricing program, including H.R. 5378 (Lower Costs, More Transparency Act), Section 202 Drug pricing reforms generally Juvenile mental and behavioral health legislation generally "Food as medicine" nutrition programs generally Medicaid Disproportionate Share Hospital payments Advanced Research Projects Agency-Health program generally H.R. 3884 (Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023), all provisions H.R. 3391 (Gabriella Miller Kids First Research Act 2.0), all provisions H.R. 3887 (Children's Hospital GME Support Reauthorization Act of 2023), all provisions Implementation of Pediatric Specialty Loan Repayment Program Medicare "site neutral" payment policy generally, including H.R. 5378 (Lower Costs, More Transparency Act), Section 203 Pediatric cancer research generally Pediatric access to cell and gene therapies generally H.R. 4822 (Health Care Price Transparency Act of 2023), all provisions H.R. 4714 / S. 2345 (Pediatricians Accelerate Childhood Therapies (PACT) Act), all provisions H.R. 2412 (Helping Kids Cope Act), all provisions H.R. 5976 / S. 3060 (Youth Mental Health Research Act), all provisions S. 2556 (Improving Coordination and Access to Resources Equitably (CARE) for Youth Act), all provisions

Client expense: $180,000 · Firm income: Not reported

Medicaid program reforms, including telemedicine and prior authorization issues Section 340B Drug Pricing program, including H.R. 5378 (Lower Costs, More Transparency Act), Section 202 Drug pricing reforms generally Juvenile mental and behavioral health legislation generally "Food as medicine" nutrition programs generally Medicaid Disproportionate Share Hospital payments Advanced Research Projects Agency-Health program generally H.R. 3884 (Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023), all provisions H.R. 3391 (Gabriella Miller Kids First Research Act 2.0), all provisions H.R. 3887 (Children's Hospital GME Support Reauthorization Act of 2023), all provisions Implementation of Pediatric Specialty Loan Repayment Program Medicare "site neutral" payment policy generally, including H.R. 5378 (Lower Costs, More Transparency Act), Section 203 Pediatric cancer research generally Pediatric access to cell and gene therapies generally H.R. 4822 (Health Care Price Transparency Act of 2023), all provisions H.R. 4714 / S. 2345 (Pediatricians Accelerate Childhood Therapies (PACT) Act), all provisions H.R. 2412 (Helping Kids Cope Act), all provisions H.R. 5976 / S. 3060 (Youth Mental Health Research Act), all provisions S. 2556 (Improving Coordination and Access to Resources Equitably (CARE) for Youth Act), all provisions

Client expense: $180,000 · Firm income: Not reported

Pediatricians Accelerate Childhood Therapies Act of 2023 (S. 2345/H.R. 4714), support all provisions

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 765/HR 1526: Reducing Hereditary Cancer Act of 2023- provide hereditary cancer genetic testing Increasing access to telehealth S 2016/HR 4189: CONNECT for Health Act- expands access to telehealth services Medicare physician payment reforms HR 2474: Strengthening Medicare for Patients and Providers Act- physician reimbursement HR 5013: Value in Health Care Act of 2023 - provides a multi-year commitment to reforming care delivery by extending MACRA's 5 percent advanced APM incentives for an additional two years. S 3503: Value in Health Care Act of 2023 - A bill to direct the Secretary of Health and Human Services to revise certain regulations in relation to the Medicare shared savings program and other alternative payment arrangements to encourage participation in such program, and for other purposes HR 6371: Provider Reimbursement Stability Act of 2023 - To provide for certain adjustments to the physician fee schedule under the Medicare program. H.R. 6369: To amend title XVIII of the Social Security Act to extend incentive payments for participation in eligible alternative payment models - Extend incentive payments for participation in alternative payment models HR 3674: Providing Relief and Stability for Medicare Patients Act of 2023 - increase the nonfacility practice expense relative value units for specified services furnished under the Medicare program Reducing burdens caused by prior authorization requirements HR 4968: GOLD CARD Act of 2023 - exempt qualifying providers from prior authorization requirements under Medicare Advantage plans S 2372/HR 4758: Accelerating Kids' Access to Care Act - improve childrens access to needed out-of-state health care by streamlining Medicaid provider screening and enrollment processes. HR 6364: Medicare Telehealth Privacy Act of 2023 - To amend title XVIII of the Social Security Act to maintain certain telehealth flexibilities relating to provider privacy under the Medicare program S 2764/HR 5391: Protecting Patient Access to Cancer and Complex Therapies Act of 2023 - ensures patients will be able to access critical medications and providers will be reimbursed fairly, unaffected by drug pricing negotiations between Medicare and drug manufacturers. S 2345/HR 4714: Pediatricians Accelerate Childhood Therapies Act of 2023 - requires the National Institutes of Health (NIH) to make awards to support early-career pediatric researchers. It also provides statutory authority for the NIH Pediatric Research Consortium to coordinate pediatric research across national health research institutions.

S. 3085, Preventing Adverse Childhood Experiences (PACE) Act S. 1409, Kids Online Safety Act (KOSA) S. 1418, Children and Teens Online Privacy Protection Act (COPPA 2.0) H.R. 4714 & S. 2345, The Pediatricians Accelerate Childhood Therapies (PACT) Act Pediatric mental health recommendations to be developed. H.R. 3226 & S.1573, The PREEMIE Reauthorization Act H.R. 3838 & S.2415, Preventing Maternal Deaths Reauthorization Act of 2023 S. 2768, Safety From Violence for Healthcare Employees (SAVE) Act H.R. 5541, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act H.R. 1843 & S. 1001, Telehealth Expansion Act of 2023 S. 3393, SUPPORT for Patients and Communities Reauthorization Act - advocated for inclusion of Community Mental Health Services Block Grant (MHBG) Prevention & Early Intervention Set Aside in reauthorization H.R. 5378, Lower Costs, More Transparency Act (hospital & 340B provisions) H.R. 5976, S. 3060 Youth Mental Health Research Act Development of future patient ID/patient matching Legislation

Client expense: $177,763 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2345 and H.R. 4714, the Pediatricians Accelerate Childhood Therapies Act; Issues pertaining to recruitment and enrollment of children within the All of Us program; NIH reform modernization.

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

Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

Pediatricians Accelerate Childhood Therapies Act of 2023 (S. 2345/H.R. 4714), support all provisions; Life Saving Leave Act (HR 3024), support all provisions.

Client expense: $80,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 4714 & S. 2345, The Pediatricians Accelerate Childhood Therapies (PACT) Act Pediatric workforce recommendations to be developed. H.R. 3305 & S.1606, Black Maternal Health Momnibus Act H.R.3226 & S.1573 The PREEMIE Reauthorization Act of 2023 H.R. 3838 & S. 2415 Preventing Maternal Deaths Reauthorization Act of 2023 H.R.3841, To amend title III of the Public Health Service Act to reauthorize the program of payments to children's hospitals that operate graduate medical education programs. Recommendations to Senate on 340B S.2840, Bipartisan Primary Care and Health Workforce Act - Oppose provisions in Title III re: offsets H.R. 3331 & S. 754, Improving Mental Health and Wellness in Schools Act H.R. 5012 & S.2647, Stillbirth Health Improvement and Education (SHINE) For Autum Act Development of future patient ID Legislation

Client expense: $195,386 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2345 and H.R. 4714, the Pediatricians Accelerate Childhood Therapies Act. Issues pertaining to recruitment and enrollment of children within the All of Us program.

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

Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE