Loading…
Drug-Price Transparency in Communications Act
Legislative Progress
Introduced
November 16, 2017
Latest Action
November 16, 2017
Primary Sponsor
Richard J. DurbinDemocratic(IL)
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
0pct
0d open
vs 3,805 other S bills in the 115th — cohort avg 41d
Drug-Price Transparency in Communications Act This bill amends the Federal Food, Drug, and Cosmetic Act to impose a civil penalty on any person who disseminates a direct-to-consumer drug advertisement that does not include the wholesale acquisition cost (the manufacturer's list price to wholesalers or direct purchasers) for a 30-day supply of the drug. The bill requires any representative of a drug manufacturer who communicates with a health care practitioner about a drug manufactured by the drug manufacturer to disclose the wholesale acquisition cost for a 30-day supply of the drug.
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (10)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2018 · fourth_quarter · Education
FY 19 Labor, HHS, Education Appropriations HR 2475 Rebuild Americas Schools Act S 1674 School Building Improvement Act H.R. 5199 Education Savings Accounts for Military Families S. 2157 Education Savings Accounts for Military Families H.R. 6830 Impact Aid Infrastructure Act
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
Preserve Access to Primary Care Services: Address the shortage of primary care physicians; provide scholarships and loan forgiveness in exchange for primary care service commitments to practice in critical shortage areas; provide grants for medical school mentorship programs and primary care training in community health centers; increase Title VII funding for primary care health programs; increase funding for the National Health Service Corps, provide regulatory relief for primary care physicians; H.R. 7192/S. 1174, the Preserving Patient Access to Primary Care Act (as first introduced in the 111th Congress). Support the Affordable Care Act (P.L. 111-148, P.L. 111-152) by: Expanding coverage and improving Medicare benefits; Providing needed protections to guard against insurance practices that unfairly limit, deny or rescind coverage based on health status; public and private health insurers should encourage preventive health care by providing full coverage, with no cost-sharing, for preventive services recommended by an expert advisory group, such as the U.S. Preventive Services Task Force; Ensuring access to primary care physicians; and beginning to bend the cost curve; Prohibiting insurers from excluding or charging excessive rates to children based on pre-existing conditions, which later will be expanded to all persons; Covering young adults on their parents' plans; Eliminating lifetime and annual limits on health insurance coverage; Requiring that health insurers spend more on patient care and less on administration; support enactment of S. 248, the Empowering States to Innovate Act, which amends the Patient Protection and Affordable Care Act (ACA) to: (1) allow states to apply for waivers of certain health insurance coverage requirements in such Act (including requirements for the establishment of qualified health plans and health insurance exchanges) for plan years beginning on or after January 1, 2014 (currently, January 1, 2017), and (2) require the waiver application process to begin not later than 180 days after the enactment of this Act; Phasing out the Medicare Part D doughnut hole; Eliminating patient cost-sharing for preventive services offered by Medicare or private insurers; Increasing Medicare and Medicaid payments to primary care physicians; Supporting the Patient-Centered Outcomes Research Institute to help physicians and patients make care decisions based on the best available evidence; Supporting the Center on Medicare and Medicaid Innovation to fund pilots of delivery models to improve outcomes and reduce costs, including patient-centered medical homes. Improve Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Provide sliding scale subsidies based on income to buy coverage from qualified plans; Qualified plans should: provide evidence-based benefits, including preventive services; and be prohibited from excluding persons with pre-existing conditions, charging them more, cherry-picking enrollees, or cancelling or failing to renew coverage; Expand Medicaid to cover all persons below the Federal Poverty Level and ensure fair payments to participating physicians; As coverage becomes affordable, all persons should participate and coverage should be guaranteed; Responsibility for financing should be shared by individuals, employers and government. Pilot test Medicare payment models that re-align incentives to support effective, efficient, patient-centered, coordinated care. Priority should be given to models designed to support the value of services provided by primary care physicians as well as to models that would create incentives, across physician specialties and sites of services, to improve the quality, effectiveness, and efficiency of care provided. Policy criteria for selecting the most promising models for pilot testing should be developed, in consultation with outside experts; The Patient-Centered Medical Home (PCMH), which has shown great promise in meeting the policy objectives suggested above, should be among the models selected for broader testing on a national pilot basis; the use of the medical home model for treatment or services under private health plans, the requirement of health plans to provide incentives to promote and report on medical home services provided, the establishment of community health teams and a primary care extension program to educate and support primary care practices in the delivery of medical home services, and the establishment of a demonstration project to educate physicians and other clinicians in training in the competencies required to deliver care consistent with the medical home care model. Veterans Care: Regarding the VA Mission Act of 2018 (H.R. 5674), the College urged Congress to ensure that veterans have access to timely, contiguous care across the spectrum of health care services, with coordination and management of that care in the hands of a primary clinician or clinical care team; that the expansion of care to non-VHA facilities does not come at the cost of maintaining or improving existing VHA services or infrastructure; and that recruitment and retention of clinicians to the VHA is valued appropriately, including reimbursement for services provided; Advocated with Congress on the need for adequate funding for the VHA for FY2019 and the long-term. Expand Coverage and Stabilizing the Insurance Market: Congress should work to help stabilize the individual health insurance market and expand coverage. Specifically by develop and introduce comprehensive market stabilization legislation that includes reinsurance options to help stabilize the markets; Expanding cost-sharing assistance eligibility to purchase insurance in the exchanges as well as increase the level of premium tax credits and cost sharing subsidies offered to purchase a qualified health plan; Introducing legislation that would block the expansion of access to short-term health plans or Association Health Plans that allow insurers to charge more to individuals with pre-existing conditions and permit them to exclude from coverage essential medical care; Supporting $690 million in discretionary funding for federal exchanges within CMS Program Operations as part of the FY2019 Labor, Health and Human Services, and Education Appropriations bill. Reduce Unnecessary Administrative Tasks on Physicians and Patients: Congress should accelerate its efforts to reduce administrative burdens on clinicians and patients, including: Passing the Standardizing Electronic Prior Authorization for Safe Prescribing Act (H.R. 4841), which standardizes electronic prior authorization for prescription drugs under Medicare Part D. Adopt even greater harmonization of such standards across the health care industry; Passing the CONNECTIONS Act (H.R. 5812) by Reps. Griffith (R-VA) and Pallone (D-NJ) that would authorize CDC grants to state-run PDMPs to improve data collection and integration into physician clinical workflow specifically, of controlled substances overdose prevention and surveillance activities; Urging health care committees in Congress with jurisdiction over Medicare to exercise their oversight authority of CMS effort to overhaul clinical documentation guidelines with input from practicing clinicians; Passing the Improving Access to Medicare Coverage Act of 2017 (S. 568/H.R. 1421), which deems patients under observation as inpatients for the purposes of satisfying the Medicare 3-day inpatient stay requirement. Health Information Technology (HIT): The College provided feedback on the Centers for Disease Control and Prevention (CDC) Request for Information (RFI) Regarding a National Test Collaborative (NTC), which sought approaches for developing a NTC that would allow for the field testing of health information technology (HIT) in a live clinical setting; expressed concern that building an entirely new testing network will be prohibitively difficult and execution could go wrong unless it is carefully designed, piloted, and tested. Emailing and conference calling with every level of every organization is labor intensive and getting participants engaged in this process will be an enormous effort; urged the need to address the patient privacy issues associated with production settings. These privacy issues may cause concern amongst hospitals and may prevent them from wanting to participate unless addressed; recommended that CDC consider building a CDC-Vendor-End User communication methodology that may be a more manageable undertaking utilizing existing infrastructures. Such a system could allow for CDC to notify EHR vendors who would notify product users when they receive an alert or guidance from CDC, using a process similar to how software updates are released. This approach does not require the sharing of protected health information nor does it require direct access into the production system. Reduce Prescription Drug Costs: Congress should increase transparency and accountability in prescription drug pricing and improve access to lower-cost generic medications by passing the Drug Price Transparency in Communications Act (S. 2157), which would require drug companies to disclose the Wholesale Acquisition Cost of an Rx in Direct-to-Consumer Advertising. Representatives should introduce the companion bill; Passing the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2017 (S. 974/H.R. 2212), which would improve patient access to alternative low-cost prescription drugs and biological products by preventing prescription drug manufacturers from misusing the FDAs Risk Evaluation and Mitigation Strategies (REMS) process to make it difficult for competing generics to be brought to the market; Passing the Medicare Prescription Drug Price Negotiation Act of 2017 (S. 41/H.R. 242), which would grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for high�cost drugs and biologics covered under Part D; Passing the Fair Accountability and Innovative Research (FAIR) Pricing Act (S. 1131/H.R. 2439), which would require drug manufacturers to disclose and provide more information about planned drug price increases, including R&D costs. Fund Workforce, Medical and Health Services Research, Public Health Initiatives: Congress should ensure funding in FY 2019 for federal programs/initiatives designed to support primary care and reject funding rescissions that would harm childrens health coverage or CMS Innovation Center. This includes funding the Primary Care and Training Enhancement (PCTE) at $71 million in order to maintain and expand the pipeline for individuals training in primary care; Funding the National Health Service Corps (NHSC) at least at $415 million in total program funding to fund scholarships and loan repayment to health care professionals to help expand the countrys primary care workforce and meet the health care needs of underserved communities; Funding the Centers for Disease Control and Prevention (CDC) and Prevention and Public Health Fund (PPHF) at $8.45 billion; including PPHF funding at $805 million; Funding the Agency for Healthcare Research and Quality (AHRQ) at $454 million, restoring the agency to its FY2010 enacted level adjusting for inflation after cuts in FY2016 and FY2017 and a small increase in FY2018 so it can help clinicians help patients by making evidence-informed decisions, fund research that serves as the evidence engine for much of the private sectors work to keep patients safe; Funding the National Institutes of Health (NIH) at $39 billion so that this nations biomedical research can continue to fund cures for disease and maintain the U.S. standing as the world leader in medical and biomedical research. Promote Continued Action to Address the Epidemic of Opioid Use: Congress should pass a comprehensive legislative package to improve prevention, education, treatment and recovery for those suffering from opioid-related addictions, including: Providing for sufficient and increased funding to address the opioid epidemic, building and expanding upon the $4.65 billion in the omnibus bill approved by Congress, with at least $1 billion for programs as authorized by CARA 2.0; Expanding access and coverage for medication assisted treatment (methadone, buprenorphine, and naltrexone to prevent opioid and substance use disorders; Rejecting any proposal to impose a three day prescribing limit for initial opioid prescriptions to ensure that doctors have appropriate flexibility to determine the proper duration of each opioid prescription; Passing the Comprehensive Addiction and Recovery Act 2.0 of 2018 (S. 2456/H.R. 5311) as a step toward a more comprehensive opioids-related package. Reduce Firearms-Related Injury and Death: Congress should pass the Assault Weapons Ban of 2018 (S. 2095/H.R. 5077), which would ban the sale of high velocity, rapid file assault rifles and large capacity ammunition magazines and bump stocks; Pass the Brady Background Expansion Act (S. 2009), to expand background checks to virtually all firearm sales in the United States; Pass the Stop Illegal Trafficking in Firearms Act of 2017 (S. 1185), and the Stop Straw Purchases Act (H.R. 5134). Both would increase penalties for individuals who unlawfully purchase firearms for other persons who are prohibited from possessing firearms (known as straw purchasers); Support $50 million in funding for the CDC to conduct such research; Pass S. 834/H.R. 1832 that authorizes funding for the CDC to conduct such research. Make Graduate Medical Education (GME) Funding More Effective: Congress should develop and pass legislation to reform GME to prioritize funding toward physician specialties where millions of patients lack access, including internal medicine specialists trained in comprehensive primary care, to: Increase the number of GME slots by at least 3,000 per year over five years for specialties facing shortages, including internal medicine, as contained in the Resident Physician Shortage Reduction Act of 2017 (S. 1301/H.R. 2267); Combine DGME/IME into a single, more functional program; broaden the GME financing structure to include all payers; Allocate GME funds transparently and to activities that further the educational mission of teaching and training residents/fellows with input from practicing clinicians and in collaboration with their professional organizations; Support continued adequate funding for the VHA and its substantial contributions to the ongoing training of the next generation of physicians. 2019 Physician Fee Schedule (PFS) and Quality Payment Program (QPP): Commented on CMS final rule on the 2019 PFS and QPP including - Urged additional refinements are needed to the final E/M documentation and payment policies to provide for immediate documentation relief, ensure the needs of complex patients are appropriately addressed, and avert negative downstream consequences; supports separate payment for technology-based communication services but urges the Agency to reconsider patient cost sharing and burdensome consent polices which may prevent uptake of these critical services; appreciates the burden relief that will result from allowing physicians to delegate Appropriate Use Criteria (AUC) consultations to appropriate clinical staff, but reiterates need to reimburse clinicians for the additional time required to conduct these consultations and pilot testing AUC in limited clinical priority areas before deploying on a larger scale to prevent widespread payment disruptions. With regard to QPP, urged greater simplifying of MIPS scoring by basing point values for individual measures on their relative value to the total MIPS score, taking every opportunity to award cross category credit, and instituting a consistent minimum 90-day reporting period across all categories; develop more Advanced APMs, particularly for small and specialty practices; opposes the use of cost measures that are deemed unreliable or inaccurate and urges CMS not to increase the weight of the Cost Category until every measure meets rigorous reliability and accuracy standards; reduce overall number of quality measures and use only those deemed valid, relevant, and reliable, such as those recommended by ACPs Performance Measurement Committee. Public Charge: The College provided comments on the Department of Homeland Securitys Notice of Proposed Rulemaking: Inadmissibility on Public Charge Grounds (DHS Docket No. USCIS-2010-0012). ACP oppose the DHS proposed rule on public charge because if finalized it would put the health of millions of children and families at risk. The proposed changes would expand the number of programs that the federal government would consider in public charge determinations to include Medicaid, the Medicare Part D Low-Income Subsidy Program, the Supplemental Nutrition Assistance Program, and potentially the Childrens Health Insurance Program (CHIP), among others. By widening public charge determinations in this way, the proposed rule would make it much more likely that lawfully present immigrants and those seeking to lawfully immigrate to the U.S. could be denied lawful permanent resident status, be denied visas, or even be deported, merely on the basis of seeking essential health, nutrition, and housing services for themselves or their families. The proposed rule would undermine the physician-patient relationship and disrupt care continuity, and it is antithetical to the Colleges mission to ensure meaningful access to health care for our patients. Immigrant Children and Pregnant Women in U.S. Custody: The College commented to the U.S. Department of Homeland Security that conditions in the U.S. Customs and Border Protection (CBP) custody are inconsistent with evidence-based recommendations for appropriate care and treatment of children and pregnant women. As such, they are not appropriate for children or pregnant women. ACP calls for a full, transparent, and public investigation of Jakelin Caal Maquins (from Guatemala) death and the circumstances surrounding it, as well as any other deaths that may have occurred in CBP or Immigration and Customs Enforcement custody. The College strongly urges the Department of Homeland Security (DHS) to implement specific meaningful steps to ensure that all children and pregnant women in CBP custody receive appropriate medical and mental health screening and necessary follow-up care by trained providers.
Client expense: $249,755 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), President of the U.S., SENATE
2018 · fourth_quarter · Health Issues
Preserve Access to Primary Care Services: Address the shortage of primary care physicians; provide scholarships and loan forgiveness in exchange for primary care service commitments to practice in critical shortage areas; provide grants for medical school mentorship programs and primary care training in community health centers; increase Title VII funding for primary care health programs; increase funding for the National Health Service Corps, provide regulatory relief for primary care physicians; H.R. 7192/S. 1174, the Preserving Patient Access to Primary Care Act (as first introduced in the 111th Congress). Support the Affordable Care Act (P.L. 111-148, P.L. 111-152) by: Expanding coverage and improving Medicare benefits; Providing needed protections to guard against insurance practices that unfairly limit, deny or rescind coverage based on health status; public and private health insurers should encourage preventive health care by providing full coverage, with no cost-sharing, for preventive services recommended by an expert advisory group, such as the U.S. Preventive Services Task Force; Ensuring access to primary care physicians; and beginning to bend the cost curve; Prohibiting insurers from excluding or charging excessive rates to children based on pre-existing conditions, which later will be expanded to all persons; Covering young adults on their parents' plans; Eliminating lifetime and annual limits on health insurance coverage; Requiring that health insurers spend more on patient care and less on administration; support enactment of S. 248, the Empowering States to Innovate Act, which amends the Patient Protection and Affordable Care Act (ACA) to: (1) allow states to apply for waivers of certain health insurance coverage requirements in such Act (including requirements for the establishment of qualified health plans and health insurance exchanges) for plan years beginning on or after January 1, 2014 (currently, January 1, 2017), and (2) require the waiver application process to begin not later than 180 days after the enactment of this Act; Phasing out the Medicare Part D doughnut hole; Eliminating patient cost-sharing for preventive services offered by Medicare or private insurers; Increasing Medicare and Medicaid payments to primary care physicians; Supporting the Patient-Centered Outcomes Research Institute to help physicians and patients make care decisions based on the best available evidence; Supporting the Center on Medicare and Medicaid Innovation to fund pilots of delivery models to improve outcomes and reduce costs, including patient-centered medical homes. Improve Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Provide sliding scale subsidies based on income to buy coverage from qualified plans; Qualified plans should: provide evidence-based benefits, including preventive services; and be prohibited from excluding persons with pre-existing conditions, charging them more, cherry-picking enrollees, or cancelling or failing to renew coverage; Expand Medicaid to cover all persons below the Federal Poverty Level and ensure fair payments to participating physicians; As coverage becomes affordable, all persons should participate and coverage should be guaranteed; Responsibility for financing should be shared by individuals, employers and government. Pilot test Medicare payment models that re-align incentives to support effective, efficient, patient-centered, coordinated care. Priority should be given to models designed to support the value of services provided by primary care physicians as well as to models that would create incentives, across physician specialties and sites of services, to improve the quality, effectiveness, and efficiency of care provided. Policy criteria for selecting the most promising models for pilot testing should be developed, in consultation with outside experts; The Patient-Centered Medical Home (PCMH), which has shown great promise in meeting the policy objectives suggested above, should be among the models selected for broader testing on a national pilot basis; the use of the medical home model for treatment or services under private health plans, the requirement of health plans to provide incentives to promote and report on medical home services provided, the establishment of community health teams and a primary care extension program to educate and support primary care practices in the delivery of medical home services, and the establishment of a demonstration project to educate physicians and other clinicians in training in the competencies required to deliver care consistent with the medical home care model. Veterans Care: Regarding the VA Mission Act of 2018 (H.R. 5674), the College urged Congress to ensure that veterans have access to timely, contiguous care across the spectrum of health care services, with coordination and management of that care in the hands of a primary clinician or clinical care team; that the expansion of care to non-VHA facilities does not come at the cost of maintaining or improving existing VHA services or infrastructure; and that recruitment and retention of clinicians to the VHA is valued appropriately, including reimbursement for services provided; Advocated with Congress on the need for adequate funding for the VHA for FY2019 and the long-term. Expand Coverage and Stabilizing the Insurance Market: Congress should work to help stabilize the individual health insurance market and expand coverage. Specifically by develop and introduce comprehensive market stabilization legislation that includes reinsurance options to help stabilize the markets; Expanding cost-sharing assistance eligibility to purchase insurance in the exchanges as well as increase the level of premium tax credits and cost sharing subsidies offered to purchase a qualified health plan; Introducing legislation that would block the expansion of access to short-term health plans or Association Health Plans that allow insurers to charge more to individuals with pre-existing conditions and permit them to exclude from coverage essential medical care; Supporting $690 million in discretionary funding for federal exchanges within CMS Program Operations as part of the FY2019 Labor, Health and Human Services, and Education Appropriations bill. Reduce Unnecessary Administrative Tasks on Physicians and Patients: Congress should accelerate its efforts to reduce administrative burdens on clinicians and patients, including: Passing the Standardizing Electronic Prior Authorization for Safe Prescribing Act (H.R. 4841), which standardizes electronic prior authorization for prescription drugs under Medicare Part D. Adopt even greater harmonization of such standards across the health care industry; Passing the CONNECTIONS Act (H.R. 5812) by Reps. Griffith (R-VA) and Pallone (D-NJ) that would authorize CDC grants to state-run PDMPs to improve data collection and integration into physician clinical workflow specifically, of controlled substances overdose prevention and surveillance activities; Urging health care committees in Congress with jurisdiction over Medicare to exercise their oversight authority of CMS effort to overhaul clinical documentation guidelines with input from practicing clinicians; Passing the Improving Access to Medicare Coverage Act of 2017 (S. 568/H.R. 1421), which deems patients under observation as inpatients for the purposes of satisfying the Medicare 3-day inpatient stay requirement. Health Information Technology (HIT): The College provided feedback on the Centers for Disease Control and Prevention (CDC) Request for Information (RFI) Regarding a National Test Collaborative (NTC), which sought approaches for developing a NTC that would allow for the field testing of health information technology (HIT) in a live clinical setting; expressed concern that building an entirely new testing network will be prohibitively difficult and execution could go wrong unless it is carefully designed, piloted, and tested. Emailing and conference calling with every level of every organization is labor intensive and getting participants engaged in this process will be an enormous effort; urged the need to address the patient privacy issues associated with production settings. These privacy issues may cause concern amongst hospitals and may prevent them from wanting to participate unless addressed; recommended that CDC consider building a CDC-Vendor-End User communication methodology that may be a more manageable undertaking utilizing existing infrastructures. Such a system could allow for CDC to notify EHR vendors who would notify product users when they receive an alert or guidance from CDC, using a process similar to how software updates are released. This approach does not require the sharing of protected health information nor does it require direct access into the production system. Reduce Prescription Drug Costs: Congress should increase transparency and accountability in prescription drug pricing and improve access to lower-cost generic medications by passing the Drug Price Transparency in Communications Act (S. 2157), which would require drug companies to disclose the Wholesale Acquisition Cost of an Rx in Direct-to-Consumer Advertising. Representatives should introduce the companion bill; Passing the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2017 (S. 974/H.R. 2212), which would improve patient access to alternative low-cost prescription drugs and biological products by preventing prescription drug manufacturers from misusing the FDAs Risk Evaluation and Mitigation Strategies (REMS) process to make it difficult for competing generics to be brought to the market; Passing the Medicare Prescription Drug Price Negotiation Act of 2017 (S. 41/H.R. 242), which would grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for high�cost drugs and biologics covered under Part D; Passing the Fair Accountability and Innovative Research (FAIR) Pricing Act (S. 1131/H.R. 2439), which would require drug manufacturers to disclose and provide more information about planned drug price increases, including R&D costs. Fund Workforce, Medical and Health Services Research, Public Health Initiatives: Congress should ensure funding in FY 2019 for federal programs/initiatives designed to support primary care and reject funding rescissions that would harm childrens health coverage or CMS Innovation Center. This includes funding the Primary Care and Training Enhancement (PCTE) at $71 million in order to maintain and expand the pipeline for individuals training in primary care; Funding the National Health Service Corps (NHSC) at least at $415 million in total program funding to fund scholarships and loan repayment to health care professionals to help expand the countrys primary care workforce and meet the health care needs of underserved communities; Funding the Centers for Disease Control and Prevention (CDC) and Prevention and Public Health Fund (PPHF) at $8.45 billion; including PPHF funding at $805 million; Funding the Agency for Healthcare Research and Quality (AHRQ) at $454 million, restoring the agency to its FY2010 enacted level adjusting for inflation after cuts in FY2016 and FY2017 and a small increase in FY2018 so it can help clinicians help patients by making evidence-informed decisions, fund research that serves as the evidence engine for much of the private sectors work to keep patients safe; Funding the National Institutes of Health (NIH) at $39 billion so that this nations biomedical research can continue to fund cures for disease and maintain the U.S. standing as the world leader in medical and biomedical research. Promote Continued Action to Address the Epidemic of Opioid Use: Congress should pass a comprehensive legislative package to improve prevention, education, treatment and recovery for those suffering from opioid-related addictions, including: Providing for sufficient and increased funding to address the opioid epidemic, building and expanding upon the $4.65 billion in the omnibus bill approved by Congress, with at least $1 billion for programs as authorized by CARA 2.0; Expanding access and coverage for medication assisted treatment (methadone, buprenorphine, and naltrexone to prevent opioid and substance use disorders; Rejecting any proposal to impose a three day prescribing limit for initial opioid prescriptions to ensure that doctors have appropriate flexibility to determine the proper duration of each opioid prescription; Passing the Comprehensive Addiction and Recovery Act 2.0 of 2018 (S. 2456/H.R. 5311) as a step toward a more comprehensive opioids-related package. Reduce Firearms-Related Injury and Death: Congress should pass the Assault Weapons Ban of 2018 (S. 2095/H.R. 5077), which would ban the sale of high velocity, rapid file assault rifles and large capacity ammunition magazines and bump stocks; Pass the Brady Background Expansion Act (S. 2009), to expand background checks to virtually all firearm sales in the United States; Pass the Stop Illegal Trafficking in Firearms Act of 2017 (S. 1185), and the Stop Straw Purchases Act (H.R. 5134). Both would increase penalties for individuals who unlawfully purchase firearms for other persons who are prohibited from possessing firearms (known as straw purchasers); Support $50 million in funding for the CDC to conduct such research; Pass S. 834/H.R. 1832 that authorizes funding for the CDC to conduct such research. Make Graduate Medical Education (GME) Funding More Effective: Congress should develop and pass legislation to reform GME to prioritize funding toward physician specialties where millions of patients lack access, including internal medicine specialists trained in comprehensive primary care, to: Increase the number of GME slots by at least 3,000 per year over five years for specialties facing shortages, including internal medicine, as contained in the Resident Physician Shortage Reduction Act of 2017 (S. 1301/H.R. 2267); Combine DGME/IME into a single, more functional program; broaden the GME financing structure to include all payers; Allocate GME funds transparently and to activities that further the educational mission of teaching and training residents/fellows with input from practicing clinicians and in collaboration with their professional organizations; Support continued adequate funding for the VHA and its substantial contributions to the ongoing training of the next generation of physicians. 2019 Physician Fee Schedule (PFS) and Quality Payment Program (QPP): Commented on CMS final rule on the 2019 PFS and QPP including - Urged additional refinements are needed to the final E/M documentation and payment policies to provide for immediate documentation relief, ensure the needs of complex patients are appropriately addressed, and avert negative downstream consequences; supports separate payment for technology-based communication services but urges the Agency to reconsider patient cost sharing and burdensome consent polices which may prevent uptake of these critical services; appreciates the burden relief that will result from allowing physicians to delegate Appropriate Use Criteria (AUC) consultations to appropriate clinical staff, but reiterates need to reimburse clinicians for the additional time required to conduct these consultations and pilot testing AUC in limited clinical priority areas before deploying on a larger scale to prevent widespread payment disruptions. With regard to QPP, urged greater simplifying of MIPS scoring by basing point values for individual measures on their relative value to the total MIPS score, taking every opportunity to award cross category credit, and instituting a consistent minimum 90-day reporting period across all categories; develop more Advanced APMs, particularly for small and specialty practices; opposes the use of cost measures that are deemed unreliable or inaccurate and urges CMS not to increase the weight of the Cost Category until every measure meets rigorous reliability and accuracy standards; reduce overall number of quality measures and use only those deemed valid, relevant, and reliable, such as those recommended by ACPs Performance Measurement Committee. Public Charge: The College provided comments on the Department of Homeland Securitys Notice of Proposed Rulemaking: Inadmissibility on Public Charge Grounds (DHS Docket No. USCIS-2010-0012). ACP oppose the DHS proposed rule on public charge because if finalized it would put the health of millions of children and families at risk. The proposed changes would expand the number of programs that the federal government would consider in public charge determinations to include Medicaid, the Medicare Part D Low-Income Subsidy Program, the Supplemental Nutrition Assistance Program, and potentially the Childrens Health Insurance Program (CHIP), among others. By widening public charge determinations in this way, the proposed rule would make it much more likely that lawfully present immigrants and those seeking to lawfully immigrate to the U.S. could be denied lawful permanent resident status, be denied visas, or even be deported, merely on the basis of seeking essential health, nutrition, and housing services for themselves or their families. The proposed rule would undermine the physician-patient relationship and disrupt care continuity, and it is antithetical to the Colleges mission to ensure meaningful access to health care for our patients. Immigrant Children and Pregnant Women in U.S. Custody: The College commented to the U.S. Department of Homeland Security that conditions in the U.S. Customs and Border Protection (CBP) custody are inconsistent with evidence-based recommendations for appropriate care and treatment of children and pregnant women. As such, they are not appropriate for children or pregnant women. ACP calls for a full, transparent, and public investigation of Jakelin Caal Maquins (from Guatemala) death and the circumstances surrounding it, as well as any other deaths that may have occurred in CBP or Immigration and Customs Enforcement custody. The College strongly urges the Department of Homeland Security (DHS) to implement specific meaningful steps to ensure that all children and pregnant women in CBP custody receive appropriate medical and mental health screening and necessary follow-up care by trained providers.
Client expense: $92,631 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), President of the U.S., SENATE
2018 · fourth_quarter · Advertising
H.R.1776/ S.771, Improving Access To Affordable Prescription Drugs Act H.R. 2439/ S.1131, Fair Accountability and Innovative Research Drug Pricing Act S.1348, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act H.R.4385, Responsibility in Drug Advertising Act H.R.4116, Transparent Drug Pricing Act S.2157, Drug-Price Transparency in Communications Act S.2478, End Taxpayer Subsidies for Drug Ads Act FTC Reauthorization Act of 2018 (Not introduced)
Client expense: Not reported · Firm income: $90,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Advertising
H.R. 1776/S. 771: Improving Access to Affordable Prescription Drugs Act; S.1989/H.R. 4077: Honest Ads Act; H.R. 6576/S. 2157: Drug-Price Transparency in Communications Act; H.R. 6157: Making consolidated appropriations for the Department of Defense, Labor, Health and Human Services, and Education, and Related Agencies for the fiscal year ending September 30,2019, and for other purposes.
Client expense: $200,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Internal Revenue Service (IRS), SENATE, Treasury, Dept of
2018 · third_quarter · Education
FY 19 Labor, HHS, Education Appropriations HR 2475 Rebuild Americas Schools Act S 1674 School Building Improvement Act H.R. 5199 Education Savings Accounts for Military Families S. 2157 Education Savings Accounts for Military Families H.R. 6830 Impact Aid Infrastructure Act
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5582: Abuse Deterrent Access Act of 2018 H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 5687: SOUND Disposal and Packaging Act - Provisions related to packaging and disposal methods with respect to certain drugs H.R. 5752: Stop Illicit Importation Act of 2018 - Provisions related to importation H.R. 5788: Synthetics Trafficking and Overdose Prevention Act of 2018 or STOP Act of 2018 H.R. 5803: SAFETY Act of 2018 - Provisions related to drug approval H.R. 6143: Patient Right to Know Drug Prices Act - Provisions related to drug pricing H. Res. 949: Providing for consideration of the bill (H.R. 6) to provide for opioid use disorder prevention, recovery, and treatment, and for other purposes; providing for consideration of the bill (H.R. 5797) to amend title XIX of the Social Security Act to allow States to provide under Medicaid services for certain individuals with opioid use disorders in institutions for mental diseases; and providing for consideration of the bill (H.R. 6082) to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 1327: SITSA Act - Provisions related to controlled substances S. 2157: Drug-Price Transparency in Communications Act S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees S. 2665: A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49) HR6, SUPPORT for Patients and Communities Act, Provisions related to BBA technical correction (Part D) HR 394/S 85 - Restoring Access to Medication Act of 2017Vaccine manufacturing practices HR 4297/S2103, Protecting Seniors Through Immunization Act; HR4993/S3253, Vaccine Access Improvement Act; HR 5333 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018Durbin/Grassley Amendment HR 6199 - Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018 H.R.6378 To reauthorize certain programs under the Pandemic and All-Hazards Preparedness Reauthorization Act S 2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act' S.2852 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018
2018 · third_quarter · Health Issues
340B Drug Discount Program ---Program Implementation & Oversight ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---H.R. 4710: 340B Pause Act ---H.R. 5598: 340B Optimization Act ---S. 2453: Ensuring the Value of the 340B Program Act Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---Transfer of Authority for National Strategic Stockpile ------S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---H.R. 6378/S.2852: Pandemic and All-Hazards Preparedness and Innovation Act (PAHPAIA) ---National Biodefense Strategy Biosimilars ---Access to Samples for Testing ---Coding ---Naming ---Interchangeability and Pharmacy Substitution ---S. 974/H.R. 2212: CREATES Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---FDA Management & Financial Accountability ---FDA Hiring Flexibility ---Priority Review Voucher Program ---Regulatory Reform & Modernization ---Use of Real World Evidence Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight ---Drug Shortages ---Supply Chain Integrity and Traceability ---Counterfeiting Drug Pricing ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 Drug Product Communications ---H.R. 1703: The Medical Products Communications Act of 2017 ---S. 2157: Drug-Price Transparency in Communications Act ---Direct to Consumer Advertising Disclosures ------H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ------H.R. 6157: Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance Programs ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for FDA ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for National Institutes of Health ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---S. 974/H.R. 2212: CREATES Act of 2017 ---H.R. 749: Lower Drug Costs Through Competition Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculations North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Transparency ---H.R. 5590: Opioid Addiction Action Plan Act ---H.R. 5002: Advancing Cutting Edge Research Act ---H.R. 5473: Better Pain Management Through Better Data Act ---H.R. 5806: 21st Century Tools for Pain Addiction Treatment ---H.R. 6: SUPPORT for Patients and Communities Act ---S.2665: Providing Clarity in Development of Pain Treatment ---S.2669: Advancing Innovation in Alternative Pain and Addiction Therapies Act ---S.2680: Opioid Crisis Response Act ---S.2769: HEAL Act Orphan Drug Issues ---Tax Credit Reimbursement for Innovative Products ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
2018 · third_quarter · Health Issues
H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to controlled substances H.R. 3545: Overdose Prevention and Patient Safety Act - Provisions related to substance use disorder records H.R. 3692: Addiction Treatment Access Improvement Act of 2017 - Provisions related to medication assisted treatment (MAT) access H.R. 4275: Empowering Pharmacists in the Fight Against Opioid Abuse Act - Provisions related to pharmacist education H.R. 4284: Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2018 - Provisions related to substance use disorder information H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements H.R. 5002: Advancing Cutting Edge Research Act - Provisions related to non-addiction pain medication H.R. 5009: Jessies Law - Provisions related to patient information H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5102: Substance Use Disorder Workforce Loan Repayment Act of 2018 - Provisions related to loan repayment program H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5327: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to opioid recovery center grants H.R. 5329: Poison Center Network Enhancement Act of 2018 - Provisions related to national poison center funding and other prevention funding H.R. 5582: Abuse Deterrent Access Act of 2018 H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 5687: SOUND Disposal and Packaging Act - Provisions related to packaging and disposal methods with respect to certain drugs H.R. 5752: Stop Illicit Importation Act of 2018 - Provisions related to importation H.R. 5762: Joint Task Force to Combat Opioid Trafficking Act of 2018 - To authorize a Joint Task Force to enhance integration of the Department of Homeland Securitys border security operations to detect, interdict, disrupt, and prevent narcotics, such as fentanyl and other synthetic opioids, from entering the United States H.R. 5788: Synthetics Trafficking and Overdose Prevention Act of 2018 or STOP Act of 2018 H.R. 5803: SAFETY Act of 2018 - Provisions related to drug approval H.R. 5811: Long-Term Opioid Efficacy Act of 2018 - Postapproval study requirements H.R. 6143: Patient Right to Know Drug Prices Act - Provisions related to drug pricing H. Res. 949: Providing for consideration of the bill (H.R. 6) to provide for opioid use disorder prevention, recovery, and treatment, and for other purposes; providing for consideration of the bill (H.R. 5797) to amend title XIX of the Social Security Act to allow States to provide under Medicaid services for certain individuals with opioid use disorders in institutions for mental diseases; and providing for consideration of the bill (H.R. 6082) to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 1327: SITSA Act - Provisions related to controlled substances S. 2157: Drug-Price Transparency in Communications Act S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees S. 2665: A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety S. 2680: Opioid Crisis Response Act of 2018 - Provisions related to opioids S. 3428: Lessening Addiction by Enhancing Labeling Opiods Act of 2018 S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)
2018 · third_quarter · Advertising
H.R. 1776/S. 771: Improving Access to Affordable Prescription Drugs Act; S.1989/H.R. 4077: Honest Ads Act; H.R. 6576/S. 2157: Drug-Price Transparency in Communications Act; H.R. 6157: Making consolidated appropriations for the Department of Defense, Labor, Health and Human Services, and Education, and Related Agencies for the fiscal year ending September 30,2019, and for other purposes.
Client expense: $150,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Internal Revenue Service (IRS), SENATE, Treasury, Dept of
2018 · third_quarter · Health Issues
Preserve Access to Primary Care Services: Address the shortage of primary care physicians; provide scholarships and loan forgiveness in exchange for primary care service commitments to practice in critical shortage areas; provide grants for medical school mentorship programs and primary care training in community health centers; increase Title VII funding for primary care health programs; increase funding for the National Health Service Corps, provide regulatory relief for primary care physicians; H.R. 7192/S. 1174, the Preserving Patient Access to Primary Care Act (as first introduced in the 111th Congress). Support the Affordable Care Act (P.L. 111-148, P.L. 111-152) by: Expanding coverage and improving Medicare benefits; Providing needed protections to guard against insurance practices that unfairly limit, deny or rescind coverage based on health status; public and private health insurers should encourage preventive health care by providing full coverage, with no cost-sharing, for preventive services recommended by an expert advisory group, such as the U.S. Preventive Services Task Force; Ensuring access to primary care physicians; and beginning to bend the cost curve; Prohibiting insurers from excluding or charging excessive rates to children based on pre-existing conditions, which later will be expanded to all persons; Covering young adults on their parents' plans; Eliminating lifetime and annual limits on health insurance coverage; Requiring that health insurers spend more on patient care and less on administration; support enactment of S. 248, the Empowering States to Innovate Act, which amends the Patient Protection and Affordable Care Act (ACA) to: (1) allow states to apply for waivers of certain health insurance coverage requirements in such Act (including requirements for the establishment of qualified health plans and health insurance exchanges) for plan years beginning on or after January 1, 2014 (currently, January 1, 2017), and (2) require the waiver application process to begin not later than 180 days after the enactment of this Act; Phasing out the Medicare Part D doughnut hole; Eliminating patient cost-sharing for preventive services offered by Medicare or private insurers; Increasing Medicare and Medicaid payments to primary care physicians; Supporting the Patient-Centered Outcomes Research Institute to help physicians and patients make care decisions based on the best available evidence; Supporting the Center on Medicare and Medicaid Innovation to fund pilots of delivery models to improve outcomes and reduce costs, including patient-centered medical homes. Medicare Physician Payment Reform: Advocated in support of H.R. 2, the Medicare Access and CHIP Reauthorization Act (MACRA), which was enacted in April 2015 and repealed Medicares Sustainable Growth Rate (SGR) formula and moved us to a new value-based payment and delivery system under Medicare; Advocated with CMS on numerous aspects of the MACRA proposed and final rules, including: proposing a distinctive alternative scoring methodology, developed by ACP, which combines, simplifies, aligns and reduces the complexity of the four reporting categories that will qualify physicians for FFS payment adjustments; proposing specific alternatives to CMS Advancing Care Information program that replaced the Meaningful Use program; proposing additional improvements to simplify the reporting requirements for the Quality, Advancing Care Information and Improvement Activities categories; urging CMS to immediately create virtual reporting options and to create safe harbors for smaller practices until such options are available; proposing more options and flexibility, instead of a one-size fits all approach, for practices to be certified as Patient-Centered Medical Homes or Patient-Centered Medical Home specialty practices, qualifying them for the highest possible score for the Clinical Practice Improvement Activity reporting category; Proposing four different options for Medical Home practices to qualify as advanced Alternative Payment Models, instead of the single option proposed by CMS, including options to allow PCMHs to qualify without taking financial risk: Advocated with CMS on Patient Relationship Categories and Codes, as required by MACRA, specifically: that CMS work to ensure that patients, families, and the relationship of patients and families with their physicians are at the forefront of the Agencys thinking in the development of both the Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) pathways; that the implementation of these categories and codes is carried out in a manner that fully considers and minimizes the impact of reporting burden on the participating clinicians and that has appropriate flexibility to allow for learning and improvement in the approach by both the Agency and the clinicians. Improve Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Provide sliding scale subsidies based on income to buy coverage from qualified plans; Qualified plans should: provide evidence-based benefits, including preventive services; and be prohibited from excluding persons with pre-existing conditions, charging them more, cherry-picking enrollees, or cancelling or failing to renew coverage; Expand Medicaid to cover all persons below the Federal Poverty Level and ensure fair payments to participating physicians; As coverage becomes affordable, all persons should participate and coverage should be guaranteed; Responsibility for financing should be shared by individuals, employers and government. The College believes that strong oversight is needed when determining the initial benchmark plan (and whether it reflects the coverage requirements of the Affordable Care Act) and how the package will be updated, particularly if insurers are given the ability to substitute benefits within and across categories. State and the federal government must work in concert with physicians, health care providers and payers to determine and promote use of clinically effective and cost-effective services that result in improved patient health while bending the cost curve. Under the Affordable Care Act, advocated to ensure that people residing in states with health insurance marketplaces operated by the federal government do not lose their cost-sharing reduction subsidies (CSRs) and that those CSRs should be continued indefinitely as part of a larger bipartisan effort to stabilize the individual insurance market. Pilot test Medicare payment models that re-align incentives to support effective, efficient, patient-centered, coordinated care. Priority should be given to models designed to support the value of services provided by primary care physicians as well as to models that would create incentives, across physician specialties and sites of services, to improve the quality, effectiveness, and efficiency of care provided. Policy criteria for selecting the most promising models for pilot testing should be developed, in consultation with outside experts; The Patient-Centered Medical Home (PCMH), which has shown great promise in meeting the policy objectives suggested above, should be among the models selected for broader testing on a national pilot basis; the use of the medical home model for treatment or services under private health plans, the requirement of health plans to provide incentives to promote and report on medical home services provided, the establishment of community health teams and a primary care extension program to educate and support primary care practices in the delivery of medical home services, and the establishment of a demonstration project to educate physicians and other clinicians in training in the competencies required to deliver care consistent with the medical home care model. Veterans Care: Regarding the VA Mission Act of 2018 (H.R. 5674), the College urged Congress to ensure that veterans have access to timely, contiguous care across the spectrum of health care services, with coordination and management of that care in the hands of a primary clinician or clinical care team; that the expansion of care to non-VHA facilities does not come at the cost of maintaining or improving existing VHA services or infrastructure; and that recruitment and retention of clinicians to the VHA is valued appropriately, including reimbursement for services provided; Advocated with Congress on the need for adequate funding for the VHA for FY2019 and the long-term. Immigration: Voiced support to Congress on the need to pass the Development, Relief, and Education for Alien Minors (DREAM) Act of 2017, H.R. 3440. This legislation would establish a three-step pathway to U.S. citizenship through college, work, or the armed services for individuals who were born in another country and brought illegally to the U.S. at a young age (DREAMers). Clinical Labs: Commented to the Centers for Medicare and Medicaid Services (CMS) on issues pertaining to the Protecting Access to Medicare Act of 2014 (PAMA), specifically citing concerns about the potential impacts of PAMA on patient access to critical rapid clinical testing services offered to patients while they are receiving medical care in their physicians office; expressed further concerns about impending cuts on Jan. 1, 2018 for physician office-based testing services. Expand Coverage and Stabilizing the Insurance Market: Congress should work to help stabilize the individual health insurance market and expand coverage. Specifically by develop and introduce comprehensive market stabilization legislation that includes reinsurance options to help stabilize the markets; Expanding cost-sharing assistance eligibility to purchase insurance in the exchanges as well as increase the level of premium tax credits and cost sharing subsidies offered to purchase a qualified health plan; Introducing legislation that would block the expansion of access to short-term health plans or Association Health Plans that allow insurers to charge more to individuals with pre-existing conditions and permit them to exclude from coverage essential medical care; Supporting $690 million in discretionary funding for federal exchanges within CMS Program Operations as part of the FY2019 Labor, Health and Human Services, and Education Appropriations bill. Reduce Unnecessary Administrative Tasks on Physicians and Patients: Congress should accelerate its efforts to reduce administrative burdens on clinicians and patients, including: Passing the Standardizing Electronic Prior Authorization for Safe Prescribing Act (H.R. 4841), which standardizes electronic prior authorization for prescription drugs under Medicare Part D. Adopt even greater harmonization of such standards across the health care industry; Passing the CONNECTIONS Act (H.R. 5812) by Reps. Griffith (R-VA) and Pallone (D-NJ) that would authorize CDC grants to state-run PDMPs to improve data collection and integration into physician clinical workflow specifically, of controlled substances overdose prevention and surveillance activities; Urging health care committees in Congress with jurisdiction over Medicare to exercise their oversight authority of CMS effort to overhaul clinical documentation guidelines with input from practicing clinicians; Passing the Improving Access to Medicare Coverage Act of 2017 (S. 568/H.R. 1421), which deems patients under observation as inpatients for the purposes of satisfying the Medicare 3-day inpatient stay requirement. Reduce Prescription Drug Costs: Congress should increase transparency and accountability in prescription drug pricing and improve access to lower-cost generic medications by passing the Drug Price Transparency in Communications Act (S. 2157), which would require drug companies to disclose the Wholesale Acquisition Cost of an Rx in Direct-to-Consumer Advertising. Representatives should introduce the companion bill; Passing the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2017 (S. 974/H.R. 2212), which would improve patient access to alternative low-cost prescription drugs and biological products by preventing prescription drug manufacturers from misusing the FDAs Risk Evaluation and Mitigation Strategies (REMS) process to make it difficult for competing generics to be brought to the market; Passing the Medicare Prescription Drug Price Negotiation Act of 2017 (S. 41/H.R. 242), which would grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for high�cost drugs and biologics covered under Part D; Passing the Fair Accountability and Innovative Research (FAIR) Pricing Act (S. 1131/H.R. 2439), which would require drug manufacturers to disclose and provide more information about planned drug price increases, including R&D costs. Fund Workforce, Medical and Health Services Research, Public Health Initiatives: Congress should ensure funding in FY 2019 for federal programs/initiatives designed to support primary care and reject funding rescissions that would harm childrens health coverage or CMS Innovation Center. This includes funding the Primary Care and Training Enhancement (PCTE) at $71 million in order to maintain and expand the pipeline for individuals training in primary care; Funding the National Health Service Corps (NHSC) at least at $415 million in total program funding to fund scholarships and loan repayment to health care professionals to help expand the countrys primary care workforce and meet the health care needs of underserved communities; Funding the Centers for Disease Control and Prevention (CDC) and Prevention and Public Health Fund (PPHF) at $8.45 billion; including PPHF funding at $805 million; Funding the Agency for Healthcare Research and Quality (AHRQ) at $454 million, restoring the agency to its FY2010 enacted level adjusting for inflation after cuts in FY2016 and FY2017 and a small increase in FY2018 so it can help clinicians help patients by making evidence-informed decisions, fund research that serves as the evidence engine for much of the private sectors work to keep patients safe; Funding the National Institutes of Health (NIH) at $39 billion so that this nations biomedical research can continue to fund cures for disease and maintain the U.S. standing as the world leader in medical and biomedical research. Promote Continued Action to Address the Epidemic of Opioid Use: Congress should pass a comprehensive legislative package to improve prevention, education, treatment and recovery for those suffering from opioid-related addictions, including: Providing for sufficient and increased funding to address the opioid epidemic, building and expanding upon the $4.65 billion in the omnibus bill approved by Congress, with at least $1 billion for programs as authorized by CARA 2.0; Expanding access and coverage for medication assisted treatment (methadone, buprenorphine, and naltrexone to prevent opioid and substance use disorders; Rejecting any proposal to impose a three day prescribing limit for initial opioid prescriptions to ensure that doctors have appropriate flexibility to determine the proper duration of each opioid prescription; Passing the Comprehensive Addiction and Recovery Act 2.0 of 2018 (S. 2456/H.R. 5311) as a step toward a more comprehensive opioids-related package. Reduce Firearms-Related Injury and Death: Congress should pass the Assault Weapons Ban of 2018 (S. 2095/H.R. 5077), which would ban the sale of high velocity, rapid file assault rifles and large capacity ammunition magazines and bump stocks; Pass the Brady Background Expansion Act (S. 2009), to expand background checks to virtually all firearm sales in the United States; Pass the Stop Illegal Trafficking in Firearms Act of 2017 (S. 1185), and the Stop Straw Purchases Act (H.R. 5134). Both would increase penalties for individuals who unlawfully purchase firearms for other persons who are prohibited from possessing firearms (known as straw purchasers); Repeal the Dickey amendment restricting firearms-related research by federal agencies and support $50 million in funding for the CDC to conduct such research; Pass S. 834/H.R. 1832 that authorizes funding for the CDC to conduct such research. Make Graduate Medical Education (GME) Funding More Effective: Congress should develop and pass legislation to reform GME to prioritize funding toward physician specialties where millions of patients lack access, including internal medicine specialists trained in comprehensive primary care, to: Increase the number of GME slots by at least 3,000 per year over five years for specialties facing shortages, including internal medicine, as contained in the Resident Physician Shortage Reduction Act of 2017 (S. 1301/H.R. 2267); Combine DGME/IME into a single, more functional program; broaden the GME financing structure to include all payers; Allocate GME funds transparently and to activities that further the educational mission of teaching and training residents/fellows with input from practicing clinicians and in collaboration with their professional organizations; Support continued adequate funding for the VHA and its substantial contributions to the ongoing training of the next generation of physicians. Title X Regulations: Commented to HHS in July on the proposed rule to revise Title X regulations (Title X of the Public Health Service Act) to ensure compliance with, and enhance implementation of, the statutory requirement that none of the funds appropriated for Title X may be used in programs where pregnancy termination is a method of family planning and related statutory requirements. The College asserts that women should have sufficient access to evidence-based family planning and sexual health information and the full range of medically accepted forms of contraception. The College opposes government restrictions that would erode or abrogate a woman's right to continue or discontinue a pregnancy. The College opposes any legislation or regulations that limit access to comprehensive reproductive health care by putting medically unnecessary restrictions on health care professionals or facilities. Kentucky Health Waiver: The College commented to CMS on Kentuckys Health Waiver expressing concern that: it would impose a substantial monthly premium on Medicaid beneficiaries; would also create a six-month lock-out period for certain enrollees who do not pay their premiums on time, which is unduly harsh; that proposed work requirements will impose an unnecessary and unjustified burden on patients to document that they are eligible for an exemption and an unnecessary and unjustified burden on physicians who may be asked to attest that their patients have an exempted medical condition. 2019 Physician Fee Schedule and Quality Payment Program: Advocated to CMS that: cognitive care of more complex patients must be recognized with higher allowed payment rates than less complex care patients; supports the overall direction of CMS's proposal to reduce the burden of documentation for E/M services, but strongly disagrees that such improvements should be contingent on acceptance of the proposal to pay a single flat fee for levels 2-5; CMS not establish a regulatory deadline (e.g. January 1, 2019 or January 1, 2020) for finalizing and implementing its flat fee E/M proposals or possible alternatives that change how E/M services would be paid; calls on CMS to move forward with implementation of their proposal to simplify E/M documentation requirements effective January 1, 2019, while alternatives to the flat fee structure are being developed and pilot-tested; supports implementation on January 1, 2019 of proposals to pay for virtual check-ins, other telehealth and technology-based services, and prolonged face-to-face visits. Short-Term Health Plans: Urged Congress to support the joint resolutions disapproving of the rule related to short-term, limited-duration insurance, as published in the federal register on August 3, 2018, that such rule shall have no force or effect.
2018 · third_quarter · Health Issues
Preserve Access to Primary Care Services: Address the shortage of primary care physicians; provide scholarships and loan forgiveness in exchange for primary care service commitments to practice in critical shortage areas; provide grants for medical school mentorship programs and primary care training in community health centers; increase Title VII funding for primary care health programs; increase funding for the National Health Service Corps, provide regulatory relief for primary care physicians; H.R. 7192/S. 1174, the Preserving Patient Access to Primary Care Act (as first introduced in the 111th Congress). Support the Affordable Care Act (P.L. 111-148, P.L. 111-152) by: Expanding coverage and improving Medicare benefits; Providing needed protections to guard against insurance practices that unfairly limit, deny or rescind coverage based on health status; public and private health insurers should encourage preventive health care by providing full coverage, with no cost-sharing, for preventive services recommended by an expert advisory group, such as the U.S. Preventive Services Task Force; Ensuring access to primary care physicians; and beginning to bend the cost curve; Prohibiting insurers from excluding or charging excessive rates to children based on pre-existing conditions, which later will be expanded to all persons; Covering young adults on their parents' plans; Eliminating lifetime and annual limits on health insurance coverage; Requiring that health insurers spend more on patient care and less on administration; support enactment of S. 248, the Empowering States to Innovate Act, which amends the Patient Protection and Affordable Care Act (ACA) to: (1) allow states to apply for waivers of certain health insurance coverage requirements in such Act (including requirements for the establishment of qualified health plans and health insurance exchanges) for plan years beginning on or after January 1, 2014 (currently, January 1, 2017), and (2) require the waiver application process to begin not later than 180 days after the enactment of this Act; Phasing out the Medicare Part D doughnut hole; Eliminating patient cost-sharing for preventive services offered by Medicare or private insurers; Increasing Medicare and Medicaid payments to primary care physicians; Supporting the Patient-Centered Outcomes Research Institute to help physicians and patients make care decisions based on the best available evidence; Supporting the Center on Medicare and Medicaid Innovation to fund pilots of delivery models to improve outcomes and reduce costs, including patient-centered medical homes. Medicare Physician Payment Reform: Advocated in support of H.R. 2, the Medicare Access and CHIP Reauthorization Act (MACRA), which was enacted in April 2015 and repealed Medicares Sustainable Growth Rate (SGR) formula and moved us to a new value-based payment and delivery system under Medicare; Advocated with CMS on numerous aspects of the MACRA proposed and final rules, including: proposing a distinctive alternative scoring methodology, developed by ACP, which combines, simplifies, aligns and reduces the complexity of the four reporting categories that will qualify physicians for FFS payment adjustments; proposing specific alternatives to CMS Advancing Care Information program that replaced the Meaningful Use program; proposing additional improvements to simplify the reporting requirements for the Quality, Advancing Care Information and Improvement Activities categories; urging CMS to immediately create virtual reporting options and to create safe harbors for smaller practices until such options are available; proposing more options and flexibility, instead of a one-size fits all approach, for practices to be certified as Patient-Centered Medical Homes or Patient-Centered Medical Home specialty practices, qualifying them for the highest possible score for the Clinical Practice Improvement Activity reporting category; Proposing four different options for Medical Home practices to qualify as advanced Alternative Payment Models, instead of the single option proposed by CMS, including options to allow PCMHs to qualify without taking financial risk: Advocated with CMS on Patient Relationship Categories and Codes, as required by MACRA, specifically: that CMS work to ensure that patients, families, and the relationship of patients and families with their physicians are at the forefront of the Agencys thinking in the development of both the Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) pathways; that the implementation of these categories and codes is carried out in a manner that fully considers and minimizes the impact of reporting burden on the participating clinicians and that has appropriate flexibility to allow for learning and improvement in the approach by both the Agency and the clinicians. Improve Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Provide sliding scale subsidies based on income to buy coverage from qualified plans; Qualified plans should: provide evidence-based benefits, including preventive services; and be prohibited from excluding persons with pre-existing conditions, charging them more, cherry-picking enrollees, or cancelling or failing to renew coverage; Expand Medicaid to cover all persons below the Federal Poverty Level and ensure fair payments to participating physicians; As coverage becomes affordable, all persons should participate and coverage should be guaranteed; Responsibility for financing should be shared by individuals, employers and government. The College believes that strong oversight is needed when determining the initial benchmark plan (and whether it reflects the coverage requirements of the Affordable Care Act) and how the package will be updated, particularly if insurers are given the ability to substitute benefits within and across categories. State and the federal government must work in concert with physicians, health care providers and payers to determine and promote use of clinically effective and cost-effective services that result in improved patient health while bending the cost curve. Under the Affordable Care Act, advocated to ensure that people residing in states with health insurance marketplaces operated by the federal government do not lose their cost-sharing reduction subsidies (CSRs) and that those CSRs should be continued indefinitely as part of a larger bipartisan effort to stabilize the individual insurance market. Pilot test Medicare payment models that re-align incentives to support effective, efficient, patient-centered, coordinated care. Priority should be given to models designed to support the value of services provided by primary care physicians as well as to models that would create incentives, across physician specialties and sites of services, to improve the quality, effectiveness, and efficiency of care provided. Policy criteria for selecting the most promising models for pilot testing should be developed, in consultation with outside experts; The Patient-Centered Medical Home (PCMH), which has shown great promise in meeting the policy objectives suggested above, should be among the models selected for broader testing on a national pilot basis; the use of the medical home model for treatment or services under private health plans, the requirement of health plans to provide incentives to promote and report on medical home services provided, the establishment of community health teams and a primary care extension program to educate and support primary care practices in the delivery of medical home services, and the establishment of a demonstration project to educate physicians and other clinicians in training in the competencies required to deliver care consistent with the medical home care model. Veterans Care: Regarding the VA Mission Act of 2018 (H.R. 5674), the College urged Congress to ensure that veterans have access to timely, contiguous care across the spectrum of health care services, with coordination and management of that care in the hands of a primary clinician or clinical care team; that the expansion of care to non-VHA facilities does not come at the cost of maintaining or improving existing VHA services or infrastructure; and that recruitment and retention of clinicians to the VHA is valued appropriately, including reimbursement for services provided; Advocated with Congress on the need for adequate funding for the VHA for FY2019 and the long-term. Immigration: Voiced support to Congress on the need to pass the Development, Relief, and Education for Alien Minors (DREAM) Act of 2017, H.R. 3440. This legislation would establish a three-step pathway to U.S. citizenship through college, work, or the armed services for individuals who were born in another country and brought illegally to the U.S. at a young age (DREAMers). Clinical Labs: Commented to the Centers for Medicare and Medicaid Services (CMS) on issues pertaining to the Protecting Access to Medicare Act of 2014 (PAMA), specifically citing concerns about the potential impacts of PAMA on patient access to critical rapid clinical testing services offered to patients while they are receiving medical care in their physicians office; expressed further concerns about impending cuts on Jan. 1, 2018 for physician office-based testing services. Expand Coverage and Stabilizing the Insurance Market: Congress should work to help stabilize the individual health insurance market and expand coverage. Specifically by develop and introduce comprehensive market stabilization legislation that includes reinsurance options to help stabilize the markets; Expanding cost-sharing assistance eligibility to purchase insurance in the exchanges as well as increase the level of premium tax credits and cost sharing subsidies offered to purchase a qualified health plan; Introducing legislation that would block the expansion of access to short-term health plans or Association Health Plans that allow insurers to charge more to individuals with pre-existing conditions and permit them to exclude from coverage essential medical care; Supporting $690 million in discretionary funding for federal exchanges within CMS Program Operations as part of the FY2019 Labor, Health and Human Services, and Education Appropriations bill. Reduce Unnecessary Administrative Tasks on Physicians and Patients: Congress should accelerate its efforts to reduce administrative burdens on clinicians and patients, including: Passing the Standardizing Electronic Prior Authorization for Safe Prescribing Act (H.R. 4841), which standardizes electronic prior authorization for prescription drugs under Medicare Part D. Adopt even greater harmonization of such standards across the health care industry; Passing the CONNECTIONS Act (H.R. 5812) by Reps. Griffith (R-VA) and Pallone (D-NJ) that would authorize CDC grants to state-run PDMPs to improve data collection and integration into physician clinical workflow specifically, of controlled substances overdose prevention and surveillance activities; Urging health care committees in Congress with jurisdiction over Medicare to exercise their oversight authority of CMS effort to overhaul clinical documentation guidelines with input from practicing clinicians; Passing the Improving Access to Medicare Coverage Act of 2017 (S. 568/H.R. 1421), which deems patients under observation as inpatients for the purposes of satisfying the Medicare 3-day inpatient stay requirement. Reduce Prescription Drug Costs: Congress should increase transparency and accountability in prescription drug pricing and improve access to lower-cost generic medications by passing the Drug Price Transparency in Communications Act (S. 2157), which would require drug companies to disclose the Wholesale Acquisition Cost of an Rx in Direct-to-Consumer Advertising. Representatives should introduce the companion bill; Passing the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2017 (S. 974/H.R. 2212), which would improve patient access to alternative low-cost prescription drugs and biological products by preventing prescription drug manufacturers from misusing the FDAs Risk Evaluation and Mitigation Strategies (REMS) process to make it difficult for competing generics to be brought to the market; Passing the Medicare Prescription Drug Price Negotiation Act of 2017 (S. 41/H.R. 242), which would grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for high�cost drugs and biologics covered under Part D; Passing the Fair Accountability and Innovative Research (FAIR) Pricing Act (S. 1131/H.R. 2439), which would require drug manufacturers to disclose and provide more information about planned drug price increases, including R&D costs. Fund Workforce, Medical and Health Services Research, Public Health Initiatives: Congress should ensure funding in FY 2019 for federal programs/initiatives designed to support primary care and reject funding rescissions that would harm childrens health coverage or CMS Innovation Center. This includes funding the Primary Care and Training Enhancement (PCTE) at $71 million in order to maintain and expand the pipeline for individuals training in primary care; Funding the National Health Service Corps (NHSC) at least at $415 million in total program funding to fund scholarships and loan repayment to health care professionals to help expand the countrys primary care workforce and meet the health care needs of underserved communities; Funding the Centers for Disease Control and Prevention (CDC) and Prevention and Public Health Fund (PPHF) at $8.45 billion; including PPHF funding at $805 million; Funding the Agency for Healthcare Research and Quality (AHRQ) at $454 million, restoring the agency to its FY2010 enacted level adjusting for inflation after cuts in FY2016 and FY2017 and a small increase in FY2018 so it can help clinicians help patients by making evidence-informed decisions, fund research that serves as the evidence engine for much of the private sectors work to keep patients safe; Funding the National Institutes of Health (NIH) at $39 billion so that this nations biomedical research can continue to fund cures for disease and maintain the U.S. standing as the world leader in medical and biomedical research. Promote Continued Action to Address the Epidemic of Opioid Use: Congress should pass a comprehensive legislative package to improve prevention, education, treatment and recovery for those suffering from opioid-related addictions, including: Providing for sufficient and increased funding to address the opioid epidemic, building and expanding upon the $4.65 billion in the omnibus bill approved by Congress, with at least $1 billion for programs as authorized by CARA 2.0; Expanding access and coverage for medication assisted treatment (methadone, buprenorphine, and naltrexone to prevent opioid and substance use disorders; Rejecting any proposal to impose a three day prescribing limit for initial opioid prescriptions to ensure that doctors have appropriate flexibility to determine the proper duration of each opioid prescription; Passing the Comprehensive Addiction and Recovery Act 2.0 of 2018 (S. 2456/H.R. 5311) as a step toward a more comprehensive opioids-related package. Reduce Firearms-Related Injury and Death: Congress should pass the Assault Weapons Ban of 2018 (S. 2095/H.R. 5077), which would ban the sale of high velocity, rapid file assault rifles and large capacity ammunition magazines and bump stocks; Pass the Brady Background Expansion Act (S. 2009), to expand background checks to virtually all firearm sales in the United States; Pass the Stop Illegal Trafficking in Firearms Act of 2017 (S. 1185), and the Stop Straw Purchases Act (H.R. 5134). Both would increase penalties for individuals who unlawfully purchase firearms for other persons who are prohibited from possessing firearms (known as straw purchasers); Repeal the Dickey amendment restricting firearms-related research by federal agencies and support $50 million in funding for the CDC to conduct such research; Pass S. 834/H.R. 1832 that authorizes funding for the CDC to conduct such research. Make Graduate Medical Education (GME) Funding More Effective: Congress should develop and pass legislation to reform GME to prioritize funding toward physician specialties where millions of patients lack access, including internal medicine specialists trained in comprehensive primary care, to: Increase the number of GME slots by at least 3,000 per year over five years for specialties facing shortages, including internal medicine, as contained in the Resident Physician Shortage Reduction Act of 2017 (S. 1301/H.R. 2267); Combine DGME/IME into a single, more functional program; broaden the GME financing structure to include all payers; Allocate GME funds transparently and to activities that further the educational mission of teaching and training residents/fellows with input from practicing clinicians and in collaboration with their professional organizations; Support continued adequate funding for the VHA and its substantial contributions to the ongoing training of the next generation of physicians. Title X Regulations: Commented to HHS in July on the proposed rule to revise Title X regulations (Title X of the Public Health Service Act) to ensure compliance with, and enhance implementation of, the statutory requirement that none of the funds appropriated for Title X may be used in programs where pregnancy termination is a method of family planning and related statutory requirements. The College asserts that women should have sufficient access to evidence-based family planning and sexual health information and the full range of medically accepted forms of contraception. The College opposes government restrictions that would erode or abrogate a woman's right to continue or discontinue a pregnancy. The College opposes any legislation or regulations that limit access to comprehensive reproductive health care by putting medically unnecessary restrictions on health care professionals or facilities. Kentucky Health Waiver: The College commented to CMS on Kentuckys Health Waiver expressing concern that: it would impose a substantial monthly premium on Medicaid beneficiaries; would also create a six-month lock-out period for certain enrollees who do not pay their premiums on time, which is unduly harsh; that proposed work requirements will impose an unnecessary and unjustified burden on patients to document that they are eligible for an exemption and an unnecessary and unjustified burden on physicians who may be asked to attest that their patients have an exempted medical condition. 2019 Physician Fee Schedule and Quality Payment Program: Advocated to CMS that: cognitive care of more complex patients must be recognized with higher allowed payment rates than less complex care patients; supports the overall direction of CMS's proposal to reduce the burden of documentation for E/M services, but strongly disagrees that such improvements should be contingent on acceptance of the proposal to pay a single flat fee for levels 2-5; CMS not establish a regulatory deadline (e.g. January 1, 2019 or January 1, 2020) for finalizing and implementing its flat fee E/M proposals or possible alternatives that change how E/M services would be paid; calls on CMS to move forward with implementation of their proposal to simplify E/M documentation requirements effective January 1, 2019, while alternatives to the flat fee structure are being developed and pilot-tested; supports implementation on January 1, 2019 of proposals to pay for virtual check-ins, other telehealth and technology-based services, and prolonged face-to-face visits. Short-Term Health Plans: Urged Congress to support the joint resolutions disapproving of the rule related to short-term, limited-duration insurance, as published in the federal register on August 3, 2018, that such rule shall have no force or effect.
2018 · third_quarter · Advertising
H.R.1776/ S.771, Improving Access To Affordable Prescription Drugs Act H.R. 2439/ S.1131, Fair Accountability and Innovative Research Drug Pricing Act S.1348, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act H.R.4385, Responsibility in Drug Advertising Act H.R.4116, Transparent Drug Pricing Act S.2157, Drug-Price Transparency in Communications Act S.2478, End Taxpayer Subsidies for Drug Ads Act FTC Reauthorization Act of 2018 (Not introduced)
Client expense: Not reported · Firm income: $90,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Education
FY 18 Labor, HHS, Education Appropriations FY 19 Labor, HHS, Education Appropriations HR 2475 Rebuild Americas Schools Act S 1674 School Building Improvement Act H.R. 5199 Education Savings Accounts for Military Families S. 2157 Education Savings Accounts for Military Families
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Health Issues
Preserve Access to Primary Care Services: Address the shortage of primary care physicians; provide scholarships and loan forgiveness in exchange for primary care service commitments to practice in critical shortage areas; provide grants for medical school mentorship programs and primary care training in community health centers; increase Title VII funding for primary care health programs; increase funding for the National Health Service Corps, provide regulatory relief for primary care physicians; H.R. 7192/S. 1174, the Preserving Patient Access to Primary Care Act (as first introduced in the 111th Congress). Support the Affordable Care Act (P.L. 111-148, P.L. 111-152) by: Expanding coverage and improving Medicare benefits; Providing needed protections to guard against insurance practices that unfairly limit, deny or rescind coverage based on health status; public and private health insurers should encourage preventive health care by providing full coverage, with no cost-sharing, for preventive services recommended by an expert advisory group, such as the U.S. Preventive Services Task Force; Ensuring access to primary care physicians; and beginning to bend the cost curve; Prohibiting insurers from excluding or charging excessive rates to children based on pre-existing conditions, which later will be expanded to all persons; Covering young adults on their parents' plans; Eliminating lifetime and annual limits on health insurance coverage; Requiring that health insurers spend more on patient care and less on administration; support enactment of S. 248, the Empowering States to Innovate Act, which amends the Patient Protection and Affordable Care Act (ACA) to: (1) allow states to apply for waivers of certain health insurance coverage requirements in such Act (including requirements for the establishment of qualified health plans and health insurance exchanges) for plan years beginning on or after January 1, 2014 (currently, January 1, 2017), and (2) require the waiver application process to begin not later than 180 days after the enactment of this Act; Phasing out the Medicare Part D doughnut hole; Eliminating patient cost-sharing for preventive services offered by Medicare or private insurers; Increasing Medicare and Medicaid payments to primary care physicians; Supporting the Patient-Centered Outcomes Research Institute to help physicians and patients make care decisions based on the best available evidence; Supporting the Center on Medicare and Medicaid Innovation to fund pilots of delivery models to improve outcomes and reduce costs, including patient-centered medical homes. Medicare Physician Payment Reform: Advocated in support of H.R. 2, the Medicare Access and CHIP Reauthorization Act (MACRA), which was enacted in April 2015 and repealed Medicares Sustainable Growth Rate (SGR) formula and moved us to a new value-based payment and delivery system under Medicare; Advocated with CMS on numerous aspects of the MACRA proposed and final rules, including: proposing a distinctive alternative scoring methodology, developed by ACP, which combines, simplifies, aligns and reduces the complexity of the four reporting categories that will qualify physicians for FFS payment adjustments; proposing specific alternatives to CMS Advancing Care Information program that replaced the Meaningful Use program; proposing additional improvements to simplify the reporting requirements for the Quality, Advancing Care Information and Improvement Activities categories; urging CMS to immediately create virtual reporting options and to create safe harbors for smaller practices until such options are available; proposing more options and flexibility, instead of a one-size fits all approach, for practices to be certified as Patient-Centered Medical Homes or Patient-Centered Medical Home specialty practices, qualifying them for the highest possible score for the Clinical Practice Improvement Activity reporting category; Proposing four different options for Medical Home practices to qualify as advanced Alternative Payment Models, instead of the single option proposed by CMS, including options to allow PCMHs to qualify without taking financial risk: Advocated with CMS on Patient Relationship Categories and Codes, as required by MACRA, specifically: that CMS work to ensure that patients, families, and the relationship of patients and families with their physicians are at the forefront of the Agencys thinking in the development of both the Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) pathways; that the implementation of these categories and codes is carried out in a manner that fully considers and minimizes the impact of reporting burden on the participating clinicians and that has appropriate flexibility to allow for learning and improvement in the approach by both the Agency and the clinicians. Improve Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Provide sliding scale subsidies based on income to buy coverage from qualified plans; Qualified plans should: provide evidence-based benefits, including preventive services; and be prohibited from excluding persons with pre-existing conditions, charging them more, cherry-picking enrollees, or cancelling or failing to renew coverage; Expand Medicaid to cover all persons below the Federal Poverty Level and ensure fair payments to participating physicians; As coverage becomes affordable, all persons should participate and coverage should be guaranteed; Responsibility for financing should be shared by individuals, employers and government. The College believes that strong oversight is needed when determining the initial benchmark plan (and whether it reflects the coverage requirements of the Affordable Care Act) and how the package will be updated, particularly if insurers are given the ability to substitute benefits within and across categories. State and the federal government must work in concert with physicians, health care providers and payers to determine and promote use of clinically effective and cost-effective services that result in improved patient health while bending the cost curve. Under the Affordable Care Act, advocated to ensure that people residing in states with health insurance marketplaces operated by the federal government do not lose their cost-sharing reduction subsidies (CSRs) and that those CSRs should be continued indefinitely as part of a larger bipartisan effort to stabilize the individual insurance market. Pilot test Medicare payment models that re-align incentives to support effective, efficient, patient-centered, coordinated care. Priority should be given to models designed to support the value of services provided by primary care physicians as well as to models that would create incentives, across physician specialties and sites of services, to improve the quality, effectiveness, and efficiency of care provided. Policy criteria for selecting the most promising models for pilot testing should be developed, in consultation with outside experts; The Patient-Centered Medical Home (PCMH), which has shown great promise in meeting the policy objectives suggested above, should be among the models selected for broader testing on a national pilot basis; the use of the medical home model for treatment or services under private health plans, the requirement of health plans to provide incentives to promote and report on medical home services provided, the establishment of community health teams and a primary care extension program to educate and support primary care practices in the delivery of medical home services, and the establishment of a demonstration project to educate physicians and other clinicians in training in the competencies required to deliver care consistent with the medical home care model. Maternal Health: Advocated for the Preventing Maternal Deaths Act, H.R. 1318, which supports state Maternal Mortality Review Committees, and promotes national information sharing through the Centers for Disease Control and Prevention (CDC), so that states can continue to learn from best practices and collaborate as needed. This bill will also put data to work through demonstration projects to eliminate disparities in maternal health outcomes. Veterans Care: Regarding the VA Mission Act of 2018 (H.R. 5674), the College urged Congress to ensure that veterans have access to timely, contiguous care across the spectrum of health care services, with coordination and management of that care in the hands of a primary clinician or clinical care team; that the expansion of care to non-VHA facilities does not come at the cost of maintaining or improving existing VHA services or infrastructure; and that recruitment and retention of clinicians to the VHA is valued appropriately, including reimbursement for services provided. Non-discrimination Protections: Urged the U.S. Department of Health and Human Services not to weaken nondiscrimination protections for lesbian, gay, bisexual, transgender, and questioning (LGBTQ) individuals under Section 1557 of the Affordable Care Act. Immigration: Voiced support to Congress on the need to pass the Development, Relief, and Education for Alien Minors (DREAM) Act of 2017, H.R. 3440. This legislation would establish a three-step pathway to U.S. citizenship through college, work, or the armed services for individuals who were born in another country and brought illegally to the U.S. at a young age (DREAMers). Clinical Labs: Commented to the Centers for Medicare and Medicaid Services (CMS) on issues pertaining to the Protecting Access to Medicare Act of 2014 (PAMA), specifically citing concerns about the potential impacts of PAMA on patient access to critical rapid clinical testing services offered to patients while they are receiving medical care in their physicians office; expressed further concerns about impending cuts on Jan. 1, 2018 for physician office-based testing services. Expand Coverage and Stabilizing the Insurance Market: Congress should work to help stabilize the individual health insurance market and expand coverage. Specifically by develop and introduce comprehensive market stabilization legislation that includes reinsurance options to help stabilize the markets; Expanding cost-sharing assistance eligibility to purchase insurance in the exchanges as well as increase the level of premium tax credits and cost sharing subsidies offered to purchase a qualified health plan; Introducing legislation that would block the expansion of access to short-term health plans or Association Health Plans that allow insurers to charge more to individuals with pre-existing conditions and permit them to exclude from coverage essential medical care; Supporting $690 million in discretionary funding for federal exchanges within CMS Program Operations as part of the FY2019 Labor, Health and Human Services, and Education Appropriations bill. Reduce Unnecessary Administrative Tasks on Physicians and Patients: Congress should accelerate its efforts to reduce administrative burdens on clinicians and patients, including: Passing the Standardizing Electronic Prior Authorization for Safe Prescribing Act (H.R. 4841), which standardizes electronic prior authorization for prescription drugs under Medicare Part D. Adopt even greater harmonization of such standards across the health care industry; Passing the CONNECTIONS Act (H.R. 5812) by Reps. Griffith (R-VA) and Pallone (D-NJ) that would authorize CDC grants to state-run PDMPs to improve data collection and integration into physician clinical workflow specifically, of controlled substances overdose prevention and surveillance activities; Urging health care committees in Congress with jurisdiction over Medicare to exercise their oversight authority of CMS effort to overhaul clinical documentation guidelines with input from practicing clinicians; Passing the Improving Access to Medicare Coverage Act of 2017 (S. 568/H.R. 1421), which deems patients under observation as inpatients for the purposes of satisfying the Medicare 3-day inpatient stay requirement. Reduce Prescription Drug Costs: Congress should increase transparency and accountability in prescription drug pricing and improve access to lower-cost generic medications by passing the Drug Price Transparency in Communications Act (S. 2157), which would require drug companies to disclose the Wholesale Acquisition Cost of an Rx in Direct-to-Consumer Advertising. Representatives should introduce the companion bill; Passing the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2017 (S. 974/H.R. 2212), which would improve patient access to alternative low-cost prescription drugs and biological products by preventing prescription drug manufacturers from misusing the FDAs Risk Evaluation and Mitigation Strategies (REMS) process to make it difficult for competing generics to be brought to the market; Passing the Medicare Prescription Drug Price Negotiation Act of 2017 (S. 41/H.R. 242), which would grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for high�cost drugs and biologics covered under Part D; Passing the Fair Accountability and Innovative Research (FAIR) Pricing Act (S. 1131/H.R. 2439), which would require drug manufacturers to disclose and provide more information about planned drug price increases, including R&D costs. Fund Workforce, Medical and Health Services Research, Public Health Initiatives: Congress should ensure funding in FY 2019 for federal programs/initiatives designed to support primary care and reject funding rescissions that would harm childrens health coverage or CMS Innovation Center. This includes funding the Primary Care and Training Enhancement (PCTE) at $71 million in order to maintain and expand the pipeline for individuals training in primary care; Funding the National Health Service Corps (NHSC) at least at $415 million in total program funding to fund scholarships and loan repayment to health care professionals to help expand the countrys primary care workforce and meet the health care needs of underserved communities; Funding the Centers for Disease Control and Prevention (CDC) and Prevention and Public Health Fund (PPHF) at $8.45 billion; including PPHF funding at $805 million; Funding the Agency for Healthcare Research and Quality (AHRQ) at $454 million, restoring the agency to its FY2010 enacted level adjusting for inflation after cuts in FY2016 and FY2017 and a small increase in FY2018 so it can help clinicians help patients by making evidence-informed decisions, fund research that serves as the evidence engine for much of the private sectors work to keep patients safe; Funding the National Institutes of Health (NIH) at $39 billion so that this nations biomedical research can continue to fund cures for disease and maintain the U.S. standing as the world leader in medical and biomedical research. Promote Continued Action to Address the Epidemic of Opioid Use: Congress should pass a comprehensive legislative package to improve prevention, education, treatment and recovery for those suffering from opioid-related addictions, including: Providing for sufficient and increased funding to address the opioid epidemic, building and expanding upon the $4.65 billion in the omnibus bill approved by Congress, with at least $1 billion for programs as authorized by CARA 2.0; Expanding access and coverage for medication assisted treatment (methadone, buprenorphine, and naltrexone to prevent opioid and substance use disorders; Rejecting any proposal to impose a three day prescribing limit for initial opioid prescriptions to ensure that doctors have appropriate flexibility to determine the proper duration of each opioid prescription; Passing the Comprehensive Addiction and Recovery Act 2.0 of 2018 (S. 2456/H.R. 5311) as a step toward a more comprehensive opioids-related package. Reduce Firearms-Related Injury and Death: Congress should pass the Assault Weapons Ban of 2018 (S. 2095/H.R. 5077), which would ban the sale of high velocity, rapid file assault rifles and large capacity ammunition magazines and bump stocks; Pass the Brady Background Expansion Act (S. 2009), to expand background checks to virtually all firearm sales in the United States; Pass the Stop Illegal Trafficking in Firearms Act of 2017 (S. 1185), and the Stop Straw Purchases Act (H.R. 5134). Both would increase penalties for individuals who unlawfully purchase firearms for other persons who are prohibited from possessing firearms (known as straw purchasers); Repeal the Dickey amendment restricting firearms-related research by federal agencies and support $50 million in funding for the CDC to conduct such research; Pass S. 834/H.R. 1832 that authorizes funding for the CDC to conduct such research. Make Graduate Medical Education (GME) Funding More Effective: Congress should develop and pass legislation to reform GME to prioritize funding toward physician specialties where millions of patients lack access, including internal medicine specialists trained in comprehensive primary care, to: Increase the number of GME slots by at least 3,000 per year over five years for specialties facing shortages, including internal medicine, as contained in the Resident Physician Shortage Reduction Act of 2017 (S. 1301/H.R. 2267); Combine DGME/IME into a single, more functional program; broaden the GME financing structure to include all payers; Allocate GME funds transparently and to activities that further the educational mission of teaching and training residents/fellows with input from practicing clinicians and in collaboration with their professional organizations; Support continued adequate funding for the VHA and its substantial contributions to the ongoing training of the next generation of physicians.
2018 · second_quarter · Health Issues
Preserve Access to Primary Care Services: Address the shortage of primary care physicians; provide scholarships and loan forgiveness in exchange for primary care service commitments to practice in critical shortage areas; provide grants for medical school mentorship programs and primary care training in community health centers; increase Title VII funding for primary care health programs; increase funding for the National Health Service Corps, provide regulatory relief for primary care physicians; H.R. 7192/S. 1174, the Preserving Patient Access to Primary Care Act (as first introduced in the 111th Congress). Support the Affordable Care Act (P.L. 111-148, P.L. 111-152) by: Expanding coverage and improving Medicare benefits; Providing needed protections to guard against insurance practices that unfairly limit, deny or rescind coverage based on health status; public and private health insurers should encourage preventive health care by providing full coverage, with no cost-sharing, for preventive services recommended by an expert advisory group, such as the U.S. Preventive Services Task Force; Ensuring access to primary care physicians; and beginning to bend the cost curve; Prohibiting insurers from excluding or charging excessive rates to children based on pre-existing conditions, which later will be expanded to all persons; Covering young adults on their parents' plans; Eliminating lifetime and annual limits on health insurance coverage; Requiring that health insurers spend more on patient care and less on administration; support enactment of S. 248, the Empowering States to Innovate Act, which amends the Patient Protection and Affordable Care Act (ACA) to: (1) allow states to apply for waivers of certain health insurance coverage requirements in such Act (including requirements for the establishment of qualified health plans and health insurance exchanges) for plan years beginning on or after January 1, 2014 (currently, January 1, 2017), and (2) require the waiver application process to begin not later than 180 days after the enactment of this Act; Phasing out the Medicare Part D doughnut hole; Eliminating patient cost-sharing for preventive services offered by Medicare or private insurers; Increasing Medicare and Medicaid payments to primary care physicians; Supporting the Patient-Centered Outcomes Research Institute to help physicians and patients make care decisions based on the best available evidence; Supporting the Center on Medicare and Medicaid Innovation to fund pilots of delivery models to improve outcomes and reduce costs, including patient-centered medical homes. Medicare Physician Payment Reform: Advocated in support of H.R. 2, the Medicare Access and CHIP Reauthorization Act (MACRA), which was enacted in April 2015 and repealed Medicares Sustainable Growth Rate (SGR) formula and moved us to a new value-based payment and delivery system under Medicare; Advocated with CMS on numerous aspects of the MACRA proposed and final rules, including: proposing a distinctive alternative scoring methodology, developed by ACP, which combines, simplifies, aligns and reduces the complexity of the four reporting categories that will qualify physicians for FFS payment adjustments; proposing specific alternatives to CMS Advancing Care Information program that replaced the Meaningful Use program; proposing additional improvements to simplify the reporting requirements for the Quality, Advancing Care Information and Improvement Activities categories; urging CMS to immediately create virtual reporting options and to create safe harbors for smaller practices until such options are available; proposing more options and flexibility, instead of a one-size fits all approach, for practices to be certified as Patient-Centered Medical Homes or Patient-Centered Medical Home specialty practices, qualifying them for the highest possible score for the Clinical Practice Improvement Activity reporting category; Proposing four different options for Medical Home practices to qualify as advanced Alternative Payment Models, instead of the single option proposed by CMS, including options to allow PCMHs to qualify without taking financial risk: Advocated with CMS on Patient Relationship Categories and Codes, as required by MACRA, specifically: that CMS work to ensure that patients, families, and the relationship of patients and families with their physicians are at the forefront of the Agencys thinking in the development of both the Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) pathways; that the implementation of these categories and codes is carried out in a manner that fully considers and minimizes the impact of reporting burden on the participating clinicians and that has appropriate flexibility to allow for learning and improvement in the approach by both the Agency and the clinicians. Improve Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Provide sliding scale subsidies based on income to buy coverage from qualified plans; Qualified plans should: provide evidence-based benefits, including preventive services; and be prohibited from excluding persons with pre-existing conditions, charging them more, cherry-picking enrollees, or cancelling or failing to renew coverage; Expand Medicaid to cover all persons below the Federal Poverty Level and ensure fair payments to participating physicians; As coverage becomes affordable, all persons should participate and coverage should be guaranteed; Responsibility for financing should be shared by individuals, employers and government. The College believes that strong oversight is needed when determining the initial benchmark plan (and whether it reflects the coverage requirements of the Affordable Care Act) and how the package will be updated, particularly if insurers are given the ability to substitute benefits within and across categories. State and the federal government must work in concert with physicians, health care providers and payers to determine and promote use of clinically effective and cost-effective services that result in improved patient health while bending the cost curve. Under the Affordable Care Act, advocated to ensure that people residing in states with health insurance marketplaces operated by the federal government do not lose their cost-sharing reduction subsidies (CSRs) and that those CSRs should be continued indefinitely as part of a larger bipartisan effort to stabilize the individual insurance market. Pilot test Medicare payment models that re-align incentives to support effective, efficient, patient-centered, coordinated care. Priority should be given to models designed to support the value of services provided by primary care physicians as well as to models that would create incentives, across physician specialties and sites of services, to improve the quality, effectiveness, and efficiency of care provided. Policy criteria for selecting the most promising models for pilot testing should be developed, in consultation with outside experts; The Patient-Centered Medical Home (PCMH), which has shown great promise in meeting the policy objectives suggested above, should be among the models selected for broader testing on a national pilot basis; the use of the medical home model for treatment or services under private health plans, the requirement of health plans to provide incentives to promote and report on medical home services provided, the establishment of community health teams and a primary care extension program to educate and support primary care practices in the delivery of medical home services, and the establishment of a demonstration project to educate physicians and other clinicians in training in the competencies required to deliver care consistent with the medical home care model. Maternal Health: Advocated for the Preventing Maternal Deaths Act, H.R. 1318, which supports state Maternal Mortality Review Committees, and promotes national information sharing through the Centers for Disease Control and Prevention (CDC), so that states can continue to learn from best practices and collaborate as needed. This bill will also put data to work through demonstration projects to eliminate disparities in maternal health outcomes. Veterans Care: Regarding the VA Mission Act of 2018 (H.R. 5674), the College urged Congress to ensure that veterans have access to timely, contiguous care across the spectrum of health care services, with coordination and management of that care in the hands of a primary clinician or clinical care team; that the expansion of care to non-VHA facilities does not come at the cost of maintaining or improving existing VHA services or infrastructure; and that recruitment and retention of clinicians to the VHA is valued appropriately, including reimbursement for services provided. Non-discrimination Protections: Urged the U.S. Department of Health and Human Services not to weaken nondiscrimination protections for lesbian, gay, bisexual, transgender, and questioning (LGBTQ) individuals under Section 1557 of the Affordable Care Act. Immigration: Voiced support to Congress on the need to pass the Development, Relief, and Education for Alien Minors (DREAM) Act of 2017, H.R. 3440. This legislation would establish a three-step pathway to U.S. citizenship through college, work, or the armed services for individuals who were born in another country and brought illegally to the U.S. at a young age (DREAMers). Clinical Labs: Commented to the Centers for Medicare and Medicaid Services (CMS) on issues pertaining to the Protecting Access to Medicare Act of 2014 (PAMA), specifically citing concerns about the potential impacts of PAMA on patient access to critical rapid clinical testing services offered to patients while they are receiving medical care in their physicians office; expressed further concerns about impending cuts on Jan. 1, 2018 for physician office-based testing services. Expand Coverage and Stabilizing the Insurance Market: Congress should work to help stabilize the individual health insurance market and expand coverage. Specifically by develop and introduce comprehensive market stabilization legislation that includes reinsurance options to help stabilize the markets; Expanding cost-sharing assistance eligibility to purchase insurance in the exchanges as well as increase the level of premium tax credits and cost sharing subsidies offered to purchase a qualified health plan; Introducing legislation that would block the expansion of access to short-term health plans or Association Health Plans that allow insurers to charge more to individuals with pre-existing conditions and permit them to exclude from coverage essential medical care; Supporting $690 million in discretionary funding for federal exchanges within CMS Program Operations as part of the FY2019 Labor, Health and Human Services, and Education Appropriations bill. Reduce Unnecessary Administrative Tasks on Physicians and Patients: Congress should accelerate its efforts to reduce administrative burdens on clinicians and patients, including: Passing the Standardizing Electronic Prior Authorization for Safe Prescribing Act (H.R. 4841), which standardizes electronic prior authorization for prescription drugs under Medicare Part D. Adopt even greater harmonization of such standards across the health care industry; Passing the CONNECTIONS Act (H.R. 5812) by Reps. Griffith (R-VA) and Pallone (D-NJ) that would authorize CDC grants to state-run PDMPs to improve data collection and integration into physician clinical workflow specifically, of controlled substances overdose prevention and surveillance activities; Urging health care committees in Congress with jurisdiction over Medicare to exercise their oversight authority of CMS effort to overhaul clinical documentation guidelines with input from practicing clinicians; Passing the Improving Access to Medicare Coverage Act of 2017 (S. 568/H.R. 1421), which deems patients under observation as inpatients for the purposes of satisfying the Medicare 3-day inpatient stay requirement. Reduce Prescription Drug Costs: Congress should increase transparency and accountability in prescription drug pricing and improve access to lower-cost generic medications by passing the Drug Price Transparency in Communications Act (S. 2157), which would require drug companies to disclose the Wholesale Acquisition Cost of an Rx in Direct-to-Consumer Advertising. Representatives should introduce the companion bill; Passing the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2017 (S. 974/H.R. 2212), which would improve patient access to alternative low-cost prescription drugs and biological products by preventing prescription drug manufacturers from misusing the FDAs Risk Evaluation and Mitigation Strategies (REMS) process to make it difficult for competing generics to be brought to the market; Passing the Medicare Prescription Drug Price Negotiation Act of 2017 (S. 41/H.R. 242), which would grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for high�cost drugs and biologics covered under Part D; Passing the Fair Accountability and Innovative Research (FAIR) Pricing Act (S. 1131/H.R. 2439), which would require drug manufacturers to disclose and provide more information about planned drug price increases, including R&D costs. Fund Workforce, Medical and Health Services Research, Public Health Initiatives: Congress should ensure funding in FY 2019 for federal programs/initiatives designed to support primary care and reject funding rescissions that would harm childrens health coverage or CMS Innovation Center. This includes funding the Primary Care and Training Enhancement (PCTE) at $71 million in order to maintain and expand the pipeline for individuals training in primary care; Funding the National Health Service Corps (NHSC) at least at $415 million in total program funding to fund scholarships and loan repayment to health care professionals to help expand the countrys primary care workforce and meet the health care needs of underserved communities; Funding the Centers for Disease Control and Prevention (CDC) and Prevention and Public Health Fund (PPHF) at $8.45 billion; including PPHF funding at $805 million; Funding the Agency for Healthcare Research and Quality (AHRQ) at $454 million, restoring the agency to its FY2010 enacted level adjusting for inflation after cuts in FY2016 and FY2017 and a small increase in FY2018 so it can help clinicians help patients by making evidence-informed decisions, fund research that serves as the evidence engine for much of the private sectors work to keep patients safe; Funding the National Institutes of Health (NIH) at $39 billion so that this nations biomedical research can continue to fund cures for disease and maintain the U.S. standing as the world leader in medical and biomedical research. Promote Continued Action to Address the Epidemic of Opioid Use: Congress should pass a comprehensive legislative package to improve prevention, education, treatment and recovery for those suffering from opioid-related addictions, including: Providing for sufficient and increased funding to address the opioid epidemic, building and expanding upon the $4.65 billion in the omnibus bill approved by Congress, with at least $1 billion for programs as authorized by CARA 2.0; Expanding access and coverage for medication assisted treatment (methadone, buprenorphine, and naltrexone to prevent opioid and substance use disorders; Rejecting any proposal to impose a three day prescribing limit for initial opioid prescriptions to ensure that doctors have appropriate flexibility to determine the proper duration of each opioid prescription; Passing the Comprehensive Addiction and Recovery Act 2.0 of 2018 (S. 2456/H.R. 5311) as a step toward a more comprehensive opioids-related package. Reduce Firearms-Related Injury and Death: Congress should pass the Assault Weapons Ban of 2018 (S. 2095/H.R. 5077), which would ban the sale of high velocity, rapid file assault rifles and large capacity ammunition magazines and bump stocks; Pass the Brady Background Expansion Act (S. 2009), to expand background checks to virtually all firearm sales in the United States; Pass the Stop Illegal Trafficking in Firearms Act of 2017 (S. 1185), and the Stop Straw Purchases Act (H.R. 5134). Both would increase penalties for individuals who unlawfully purchase firearms for other persons who are prohibited from possessing firearms (known as straw purchasers); Repeal the Dickey amendment restricting firearms-related research by federal agencies and support $50 million in funding for the CDC to conduct such research; Pass S. 834/H.R. 1832 that authorizes funding for the CDC to conduct such research. Make Graduate Medical Education (GME) Funding More Effective: Congress should develop and pass legislation to reform GME to prioritize funding toward physician specialties where millions of patients lack access, including internal medicine specialists trained in comprehensive primary care, to: Increase the number of GME slots by at least 3,000 per year over five years for specialties facing shortages, including internal medicine, as contained in the Resident Physician Shortage Reduction Act of 2017 (S. 1301/H.R. 2267); Combine DGME/IME into a single, more functional program; broaden the GME financing structure to include all payers; Allocate GME funds transparently and to activities that further the educational mission of teaching and training residents/fellows with input from practicing clinicians and in collaboration with their professional organizations; Support continued adequate funding for the VHA and its substantial contributions to the ongoing training of the next generation of physicians.
2018 · second_quarter · Advertising
H.R.1776/ S.771, Improving Access To Affordable Prescription Drugs Act H.R. 2439/ S.1131, Fair Accountability and Innovative Research Drug Pricing Act S.1348, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act H.R.4385, Responsibility in Drug Advertising Act H.R.4116, Transparent Drug Pricing Act S.2157, Drug-Price Transparency in Communications Act S.2478, End Taxpayer Subsidies for Drug Ads Act FTC Reauthorization Act of 2018 (Not introduced)
Client expense: Not reported · Firm income: $210,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · first_quarter · Education
FY 18 Education Appropriations HR 2475 Rebuild Americas Schools Act S 1674 School Building Improvement Act H.R. 5199 Education Savings Accounts for Military Families S. 2157 Education Savings Accounts for Military Families
Client expense: Not reported · Firm income: Not reported
2018 · first_quarter · Pharmacy
S. 771/HR 1776-Improving access to affordable Prescription Drugs act, S 2157-Drug Price transparency in Communications Act, S 2011/HR 4138-Medicare drug price negotiation act of 2017, S 1688-Empowering medicare seniors to negotiate drug prices of 2017, S 252-Medicare drug savings act of 2017, S 1369/HR 2974-Stop Price gouging act, S 124-Preserve access to affordable generics act, S 974/HR 2212-CREATES Act of 2017, S 495-Medical Innovation and Prize Fund Act, S 1131/HR 2439-FAIR drug pricing act, Over-the-counter Monograph Safety, Innovation, and Reform Act of 2018, HR 4117-Competitive DRUGS Act of 2017), HR 2051- FAST Generics Act of 2017), Prescription drug pricing, PACED Act, S 771/HR 1776 (Improving access to affordable prescription drugs act, S 1509/HR 1223 OPEN Act), S 1309-Stronger patents act, HR 5150 Protecting Medicare from excessive price increases act, S 2476-Expanding access to low cost generics act, S 637 (c-thru act), S 1348-SPIKE act,
Client expense: $60,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)
2018 · first_quarter · Advertising
H.R.1776/ S.771, Improving Access To Affordable Prescription Drugs Act H.R. 2439/ S.1131, Fair Accountability and Innovative Research Drug Pricing Act S.1348, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act H.R.4385, Responsibility in Drug Advertising Act H.R.4116, Transparent Drug Pricing Act S.2157, Drug-Price Transparency in Communications Act S.2478, End Taxpayer Subsidies for Drug Ads Act FTC Reauthorization Act of 2018 (Not introduced)
Client expense: Not reported · Firm income: $240,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · fourth_quarter · Health Issues
S. 1976 - Increasing Access to Care Act H.R. 4200 - Healthcare Market Certainty and Mandate Relief Act of 2017 H.R. 3928 - Truth in Healthcare Marketing Act of 2017 S. 2001 - State Public Option Act H.R. 4129 - State Public Option Act H.R. 4128 - Health Care Choice and Affordability Act H.R. 4695 - Bipartisan Market Stabilization and Innovation Act of 2017 S. 2256 - Tax Extender Act of 2017 S. 2253 - CHIP Mental Health Parity Act H.R. 4666 - Premium Relief Act of 2017 H.R. 4620 - Protecting Families and Small Businesses Act of 2017 H.R. 4613 - Ensuring Patient Access to Healthcare Records Act of 2017 H.R. 4575 - Access to Independent Health Insurance Advisors Act of 2017 H.R. 4579 - Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 S. 2021 - Health Care Choice Act of 2017 H.R. 3921 - HEALTHY KIDS Act S. 1970 - Medicare-X Choice Act of 2017 H.R. 4094 - Medicare-X Choice Act of 2017 H.R. 4733 - Opioids and STOP Pain Initiative Act S. 2260 - Opioids and STOP Pain Initiative Act S. 2183 - CHIP Stability Act H.R. 4541 - CHAMPION KIDS Act of 2017 H.R. 4613 - Ensuring Patient Access to Healthcare Records Act of 2017 H.R. 4482 - Opioid Abuse Deterrence, Research and Recovery Act of 2017 H.R. 4515 - To amend title XXI of the Social Security Act to provide for a special rule during the first quarter of fiscal year 2018 for the redistribution of certain Childrens Health Insurance Program allocations for certain shortfall States. S. 2172 - Medical Innovation Act of 2017 H.R. 4456 - Health Care Sharing Fairness Act S. 2157 - Drug-Price Transparency in Communications Act H.R. 4408 - Opioid Addiction Prevention Act of 2017 H.R. 4404 - State CHIP Flexibility Act of 2017 S. 2132 - Family Coverage Act H.R. 4394 - Bare County Buy-in Act of 2017 S. 2121 - Ensuring Access to Air Ambulance Services Act of 2017 H.R. 4206 - Medicare Care Coordination Improvement Act of 2017 S. 2052 - Health Care Market Certainty and Mandate Relief Act S. 2051 - Medicare Care Coordination Improvement Act of 2017 S. 2050 - Health Care Market Certainty and Mandate Relief Act H.R. 4116 - Transparent Drug Pricing Act of 2017 S. 1978 - Small Business and Family Health Tax Relief Act of 2017 H.R. 4004 - To amend the Patient Protection and Affordable Care Act to require employees of the White House to enroll in Obamacare, and for other purposes. H.R. 3976 - Access to Marketplace Insurance Act H.R. 3964 - Opioid Addiction Prevention Act of 2017 H.R. 3927 - To amend title XXI to allow for the blending of risk pools of childrens health insurance buy-in programs with the risk pools of State child health plans under such title, and for other purposes H.R. 3919 - Commonsense Reporting Act of 2017 S. 1909 - BENES Act of 2017 S. 1908 - Commonsense Reporting Act of 2017 H.R. 1319 - Local and Municipal Health Care Choice Act of 2017 H.R. 3798- Save American Workers Act of 2017
2017 · fourth_quarter · Advertising
H.R. 1, An Act to provide for reconciliation pursuant to titles II and V of the concurrent resolution on the budget for fiscal year 2018 H.R.1776/ S.771, Improving Access To Affordable Prescription Drugs Act H.R. 2439/ S.1131, Fair Accountability and Innovative Research Drug Pricing Act S.1348, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act H.R.4385, Responsibility in Drug Advertising Act H.R.4116, Transparent Drug Pricing Act S.2157, Drug-Price Transparency in Communications Act FTC Reauthorization Act of 2017 (Not introduced)
Client expense: Not reported · Firm income: $110,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
| Democratic |
| NY |
| Margaret Wood Hassan | Democratic | NH |
| Richard Blumenthal | Democratic | CT |
| Sherrod Brown | Democratic | OH |
Client expense: $1,130,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Client expense: $2,480,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Client expense: $5,990,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE
Client expense: $279,872 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), President of the U.S., SENATE
Client expense: $97,099 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), President of the U.S., SENATE
Client expense: $388,427 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), President of the U.S., SENATE
Client expense: $89,568 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), President of the U.S., SENATE
Client expense: $330,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE, Treasury, Dept of, White House Office