Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
0pct
0d open
vs 9,062 other HR bills in the 116th — cohort avg 39d
Safe Step Act This bill requires a group health plan to establish an exception to medication step-therapy protocol in specified cases. A medication step-therapy protocol establishes a specific sequence in which prescription drugs are covered by a group health plan or a health insurance issuer. A request for such an exception to the protocol must be granted if (1) the treatment is expected to be ineffective, (2) the treatment will cause or is likely to cause an adverse reaction to the individual, (3) the treatment is expected to decrease the individual's ability either to perform daily activities or occupational responsibilities or adhere to the treatment plan, (4) the individual is stable based on the prescription drugs already selected, or (5) there are other medical reasons that warrant withholding the treatment. The bill requires a group health plan to implement and make readily available a clear process for an individual to request an exception to the protocol. Requests must be granted no later than three days after receipt of the request. In certain cases where the life, health, and ability of the individual are jeopardized by the protocol, the request shall be granted no later than 24 hours after receipt of the request.
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Filing registrants (46)
Referred to the House Committee on Education and Labor.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2021 · second_quarter · Health Issues
Health issues impacting patients with rare diseases. Rare disease initiatives. Telehealth. Step Therapy. H.R.2279/S.2546: Safe Step Act. Newborn screening. Genetic testing. Health equity. Affordable Care Act (ACA) issues. Affordable Care Act (ACA) enhancements. Drug Pricing and Orphan Drug Act. COVID-19 Related Issues. Medical Nutrition.
Client expense: $40,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2021 · first_quarter · Health Issues
The Affordable Care Act (P.L. 111-148, P.L. 111-152): 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; Advocated against a December 2018 ruling by a federal judge in Texas that the entire Affordable Care Act (ACA) is unconstitutional. 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. 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. Medicare Payments to Physicians: Urged that Congress provide incentives to physicians who transform their practices into Advanced Alternative Payment Models and continue to provide stability for physicians in the MIPS program. Specifically, Congress should extend the five percent Qualified Alternative Payment Model participant bonus beyond the 2022 performance year, replace the zero percent baseline payment updates under Medicare with positive updates. Urged congressional committees with jurisdiction over Medicare to exercise their oversight authority and urge CMS to expedite approval of more Advanced APMS, particularly those that work for small and specialty practices and to simplify the scoring structure and reporting requirements under the Merit-Based Incentive Payment System (MIPS) in order to fulfill Congress intent of a more streamlined program that reduces burdens on physicians; Supported S.2648, the Rural ACO Improvement Act, amends title XVIII of the Social Security Act to improve the benchmarking process for the Medicare Shared Savings Program (MSSP) to ensure that all ACOs have an equal opportunity to share in savings regardless of their geographic location; Provided recommendations to CMS on the Merit-based Incentive Payment System Value Pathway (MVP), which aims to reduce reporting burden and complexity within MIPS while improving the accuracy and effectiveness of performance measurement. The College noted specifically that a robust, multi-year transition period will be critical to the success of the MVP, that it does not support making the MVP mandatory, that CMS should continue to support numerous reporting mechanisms, including qualified registries and clinical data registries, which have been instrumental in developing specialty-specific performance measures, among other things. Urged support for H.R. 8505, a bill to provide for a one-year waiver of budget neutrality adjustments under the Medicare physician fee schedule; Urged that any legislation to hold some Medicare physician payment codes harmless from budget neutrality do so for just one year and to allow evaluation and management increases, along with GPC1X codes to go into effect. Administrative Tasks on Physicians and Patients: Congress should accelerate its efforts to reduce administrative burdens on clinicians and patients, including: streamlining the prior authorization process, better integrating clinical data into clinicians electronic health records (EHRs), and working with CMS in their effort to overhaul clinical documentation guidelines; Urged Congress to cosponsor and pass the Safe Step Act (H.R. 2279), to require health insurers to provide an exceptions process for any medication step therapy protocol based on clinical decision-making, medical necessity, and other patient needs. Prescription Drug Costs: The College advocated for greater transparency in drug pricing, the elimination of anti-competitive industry practices that create barriers to generics coming to market, the importance of accounting for value in payment and coverage for prescriptions, and providing authority to the federal government to negotiate drug discounts under the Medicare Part D program. Specifically, the College urged Congress to pass the Medicare Prescription Drug Price Negotiation Act of 2019 (H.R. 275/S. 62) from the 116th Congress, which allows the Secretary of Health and Human Services to negotiate covered Part D drug prices on behalf of Medicare beneficiaries. Also urged that Congress pass the Reforming Evergreening and Manipulation that Extends Drug Years, REMEDY Act (S. 1209), from the 116th Congress, to aid in the approval of more generic drug applications by the FDA and therefore improve patient access to those medications. Also urged that Congress pass the Prescription Drug STAR Act (H.R. 2113), and the Fair Accountability and Innovative Research (FAIR) Drug Pricing Act (H.R. 2296/S. 1391), from the 116th Congress, to promote greater drug pricing transparency. Firearms-Related Injury and Death: The College advocated for lawmakers to pass measures to strengthen the criminal background check system, ban assault weapons and high capacity magazines, prevent the unlawful transfer of firearms to those who cannot legally purchase them, and remove restrictions on, and provide dedicated funding for, research by federal agencies on prevention of firearms-related injuries and death. Specifically, the College urged passage of the Bipartisan Background Checks Act of 2019 (H.R. 8), from the 116th Congress, which would strengthen the accuracy and reporting of the National Instant Criminal Background Check System (NICS) as well as expand Brady background checks to cover all firearm sales, including unlicensed firearms sellers currently not required to use background checks, and the Gun Violence Prevention Research Act (H.R. 674/S. 184), from the 116th Congress, which would authorize funding for the Centers for Disease Control and Prevention (CDC) to study firearms safety and gun violence prevention. Also urged Congress to pass the Violence Against Women (VAWA) Reauthorization Act of 2021, which passed the House in 2021, to provide protections for domestic violence victims by restricting access to firearms by those deemed a threat to them. Also urged Congress to pass the Assault Weapons Ban of 2019 (S. 66/H.R. 1296), from the 116th Congress, to ban the sale of semi-automatic weapons and high-capacity magazines. Urged support for the enactment of extreme risk protection orders (ERPO) to allow families and law enforcement to obtain a ruling from an impartial judge within 72 hours to temporarily remove guns from individuals at imminent risk of using them to harm themselves or others, with due process. Immigration: The College advocated against family separation at the U.S. border. Specifically, the College urged support for bills from the 116th Congress such as H.R. 541 - the Keep Families Together Act, which would help ensure that children are not separated from their parents when families unlawfully cross over the border into the United States and would ensure that the Department of Homeland Security would not be able to implement the zero tolerance policy that separated families at the border under the last administration; urged congressional oversight of family separation policies. Also urged that Congress pass H.R. 6, the Dream and Promise Act of 2019, which would provide a pathway to U.S. citizenship for undocumented children who came to the United States due to the action of their parents, also known as Dreamers. Graduate Medical Education: Urged that Congress support medical education training and debt relief for primary care physicians and other specialties facing shortages by passing the following legislation from the 116th Congress: the Resident Physician Shortage Reduction Act of 2019 (S. 348, H.R. 1763), to lift the GME caps as needed to permit training an adequate number of primary care physicians, including internal medicine specialists, and physicians in other specialties facing shortages; passing the Resident Education Deferred Interest Act (H.R. 1554), to save physicians in residency programs thousands of dollars in interest on their loans and help incentivize the opening of practices in underserved areas; pass legislation to combine DGME and IME into a single, more functional payment program, and broaden the GME financing structure to include all payers; support funding for GME/IME and programs within the Veterans Health Administration that provide graduate medical education to ensure that physicians are adequately trained with the skills needed to treat an aging population. Urged Congress to pass the Opioid Workforce Act of 2019 (H.R. 3414), which would provide Medicare support for an additional 1,000 graduate medical education (GME) positions over five years in hospitals that have, or are in the process of establishing, accredited residency programs in addiction medicine, addiction psychiatry, or pain medicine. Urged Congress to pass S. 1203 and H.R. 2441, the What You Can Do For Your Country Act, which would improve and reform the Public Service Loan Forgiveness (PSLF) Program. Vaccines: Urged Congress to pass the Vaccines Act (HR 2862), from the 116th Congress, which would provide federal funding for vaccine hesitancy surveillance at the Centers for Disease Control and Prevention (CDC), and outline a national public messaging campaign informed by this research to help improve vaccination rates. Physician Fee Schedule: Commented to CMS and to Congress to fully implement payment increases for all evaluation and management codes, as finalized by CMS, and as scheduled for implementation on Jan. 1, 2021. Reduce the documentation burden for E/M services by allowing choice of medical decision making or time, and work to develop additional clarity and guidance on acceptable documentation to operationalize these important proposals; examination room desktop computers should be counted as a direct medical equipment cost; care management should be promoted by increasing the values of services like Transitional Care Management (TCM) and Chronic Care Management and implementing Principle Care Management (PCM) codes; require additional survey and review for any requests to increase non-outpatient E/M or other services; work with the physician community prior to finalizing any policy affecting eligibility to participate in the Medicare program; Urged congressional committees of jurisdiction to support: Higher physician work relative value units (RVUs) for new and established office visit codes, leading to increased payments for them, Reduced documentation requirements for office visit codes, which enables physicians to select and document for each visit based on medical decision-making or total time, Expanded and improved payment for care management services. Urged Congress to support waiving budget neutrality, applicable to the calendar year 2021 physician fee schedule. COVID-19: Urged congressional appropriators to provide the highest possible funding level for research, prevention, control, and treatment of illnesses associated with the virus that is commensurate with the public health emergency that the virus represents. Urged the administration to explore regulatory and other actions that would make COVID-19 testing free-of-charge to patients covered by both public and private insurance plans, including ACA-compliant plans offered through the insurance exchanges, and to waive co-pays and deductibles for patients seeing physicians for symptoms that may be indicative of COVID-19 or who are hospitalized for treatment. Urged CMS to utilize a national disaster recovery program that would pay doctors 110% of Medicare rates for caring for uninsured patients who have been infected with SARS-CoV-2. Expressed support to Congress and the administration for a variety of COVID-related bills from the 116th Congress as follows: the Families First Coronavirus Response Act, H.R. 6201, and other stimulus reforms related to COVID-19 including: Emergency paid leave benefits, paid sick days for public health emergencies, coverage of testing for COVID-19, waiving of cost sharing under Medicare, Medicare Advantage, Medicaid, and CHIP, increasing the federal FMAP under Medicaid, providing reimbursement for CPT codes 99441 - 99443, which are telephone evaluation and management services, expediting entrance of international medical graduates who are citizens of other nations (non-US IMGs) into the country and ensuring that lawfully present non-U.S. IMGs are not negatively impacted by the COVID-19 pandemic, funding for physician practices under the Public Health and Social Service Emergency Fund (PHSSEF), providing tax relief, grants, and loans to small and medium size practices impacted by COVID-19, increasing funding for personal protective equipment (PPE), ensuring Medicaid pay parity with Medicare for primary care services; Urged HHS and Congress to make a targeted allocation out of the Provider Relief Fund (PRF) to support primary care physicians and their practices, sufficient to keep their doors open, by offsetting lost revenue from the COVID-19 pandemic, similar to the targeted allocation for rural hospitals; Urged support for the Student Loan Forgiveness for Frontline Health Workers Act, H.R. 6720, introduced May 5, 2020 by Representative Carolyn B. Maloney (D-NY) which would eliminate graduate school debt for healthcare workers, including physicians and medical students, who are providing direct patient care in response to the COVID-19 pandemic; Urged support for H.R. 7059, the Coronavirus Provider Protection Act, which extend liability protections to those who provide care in good faith during the COVID-19 public health emergency (plus a reasonable time, such as 60 days, after the emergency declaration ends), and not in situations of gross negligence or willful misconduct. The College also urged that pay parity between telephone claims and in-person visits and between all telehealth and in-person visits be maintained after the PHE is lifted. This extension-either continued by CMS or mandated by Congress-should last at least through the end of 2021, or until such a time when effective vaccines and treatments are widely available, with an option to extend it even further, or consider making permanent, based on the experience and learnings of patients and physicians who are utilizing these visits. Urged Congress to support a targeted allocation from the Provider Relief Fund specifically for primary care services. Priorities for the Biden Administration: Urged the Biden Administration to identify and appoint physicians to health care leadership positions within his Administration. Implement approval, distribution, and funding of a safe and effective COVID-19 vaccine based on recommendations from the Advisory Committee on Immunization Practices (ACIP). Provide support to physicians and other frontline health care workers, including ensuring access and distribution of personal protective equipment (PPE) to health care workers. Fund COVID-19 testing and contact tracing efforts. Reverse regulations that allow the sale of extended short-term, limited duration plans, association health plans. Take action to defend the Affordable Care Act from any litigation, including California v. Texas, that would undermine coverage and patient protections. Expand premium tax credits and cost-sharing reductions. Establish a federal public option to inject competition into the health insurance marketplace. Expand Medicaid eligibility and oppose expansion waivers that limit benefits and apply high cost sharing. Permanently increase payment for Medicaid primary care services to the level of Medicare. Restore the Deferred Action for Childhood Arrivals, consistent with a recent ruling from a federal judge, and identify executive actions that can be taken to ensure that it is not vulnerable to being eliminated in the future. Pursue executive actions to preserve the principles of patient autonomy regarding reproductive decision-making rights. Reverse the Title X gag rule and restore funding to family planning clinics. Establish universal access to at least six weeks of paid family and medical leave that is flexible to accommodate care for a diverse array of family structures, including updating the Family Medical and Leave Act to include grandparents or in-laws. Re-introduce and pass the George Floyd Act and other legislation focused on eliminating racism and police violence. Rejoin the Paris Agreement. Telehealth: Urged Congress to continue existing Public Health Emergency flexibilities and waivers-including pay parity for audio-only phone calls-to support making telehealth an ongoing and continued part of medical care now and in the future, allowing time for further evaluation on which ones should be maintained as is, revised or expanded. Urged Congress to permanently extend the policy to waive geographical and originating-site restrictions after the conclusion of the PHE. Urged Congress or CMS to continue to provide flexibility in the Medicare and Medicaid programs for physician practices to reduce or waive cost-sharing requirements for telehealth services, while also making up the difference between these waived copays and the Medicare allowed amount of the service. Urged Congress or CMS to extend the interim policy to allow Remote Patient Monitoring services to be furnished to patients without an established relationship. Urged support for the Temporary Reciprocity to Ensure Access to Treatment Act or the TREAT Act (S. 168/H.R. 708), which would provide temporary licensing reciprocity for telehealth and interstate health care treatment. American Rescue Plan (ARP) Act (H.R. 1319): Urged support for various provisions within the ARP to provide incentives for states to expand Medicaid by temporarily increasing the states base FMAP by five percentage points for two years for states that newly expand Medicaid. Urged support for allowing states, for five years, to extend Medicaid eligibility (and CHIP eligibility) to women for 12 months postpartum. Urged support to require Medicaid coverage of COVID-19 vaccines and treatment without beneficiary cost sharing with vaccines matched at a 100 percent federal medical assistance percentage (FMAP) through one year after the end of the PHE. Urged support for $46 billion to HHS to detect, diagnose, trace, and monitor COVID-19 infections, and for other activities necessary to mitigate the spread of COVID-19. Urged support to subsidize the health coverage of people earning up to 150 percent of the federal poverty level (FPL) under the ACA and those on unemployment insurance for a period of two years. Urged support for waiving VA cost sharing and copayments for medical treatment until September 30, 2021.
2021 · first_quarter · Health Issues
The Affordable Care Act (P.L. 111-148, P.L. 111-152): 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; Advocated against a December 2018 ruling by a federal judge in Texas that the entire Affordable Care Act (ACA) is unconstitutional. 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. 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. Medicare Payments to Physicians: Urged that Congress provide incentives to physicians who transform their practices into Advanced Alternative Payment Models and continue to provide stability for physicians in the MIPS program. Specifically, Congress should extend the five percent Qualified Alternative Payment Model participant bonus beyond the 2022 performance year, replace the zero percent baseline payment updates under Medicare with positive updates. Urged congressional committees with jurisdiction over Medicare to exercise their oversight authority and urge CMS to expedite approval of more Advanced APMS, particularly those that work for small and specialty practices and to simplify the scoring structure and reporting requirements under the Merit-Based Incentive Payment System (MIPS) in order to fulfill Congress intent of a more streamlined program that reduces burdens on physicians; Supported S.2648, the Rural ACO Improvement Act, amends title XVIII of the Social Security Act to improve the benchmarking process for the Medicare Shared Savings Program (MSSP) to ensure that all ACOs have an equal opportunity to share in savings regardless of their geographic location; Provided recommendations to CMS on the Merit-based Incentive Payment System Value Pathway (MVP), which aims to reduce reporting burden and complexity within MIPS while improving the accuracy and effectiveness of performance measurement. The College noted specifically that a robust, multi-year transition period will be critical to the success of the MVP, that it does not support making the MVP mandatory, that CMS should continue to support numerous reporting mechanisms, including qualified registries and clinical data registries, which have been instrumental in developing specialty-specific performance measures, among other things. Urged support for H.R. 8505, a bill to provide for a one-year waiver of budget neutrality adjustments under the Medicare physician fee schedule; Urged that any legislation to hold some Medicare physician payment codes harmless from budget neutrality do so for just one year and to allow evaluation and management increases, along with GPC1X codes to go into effect. Administrative Tasks on Physicians and Patients: Congress should accelerate its efforts to reduce administrative burdens on clinicians and patients, including: streamlining the prior authorization process, better integrating clinical data into clinicians electronic health records (EHRs), and working with CMS in their effort to overhaul clinical documentation guidelines; Urged Congress to cosponsor and pass the Safe Step Act (H.R. 2279), to require health insurers to provide an exceptions process for any medication step therapy protocol based on clinical decision-making, medical necessity, and other patient needs. Prescription Drug Costs: The College advocated for greater transparency in drug pricing, the elimination of anti-competitive industry practices that create barriers to generics coming to market, the importance of accounting for value in payment and coverage for prescriptions, and providing authority to the federal government to negotiate drug discounts under the Medicare Part D program. Specifically, the College urged Congress to pass the Medicare Prescription Drug Price Negotiation Act of 2019 (H.R. 275/S. 62) from the 116th Congress, which allows the Secretary of Health and Human Services to negotiate covered Part D drug prices on behalf of Medicare beneficiaries. Also urged that Congress pass the Reforming Evergreening and Manipulation that Extends Drug Years, REMEDY Act (S. 1209), from the 116th Congress, to aid in the approval of more generic drug applications by the FDA and therefore improve patient access to those medications. Also urged that Congress pass the Prescription Drug STAR Act (H.R. 2113), and the Fair Accountability and Innovative Research (FAIR) Drug Pricing Act (H.R. 2296/S. 1391), from the 116th Congress, to promote greater drug pricing transparency. Firearms-Related Injury and Death: The College advocated for lawmakers to pass measures to strengthen the criminal background check system, ban assault weapons and high capacity magazines, prevent the unlawful transfer of firearms to those who cannot legally purchase them, and remove restrictions on, and provide dedicated funding for, research by federal agencies on prevention of firearms-related injuries and death. Specifically, the College urged passage of the Bipartisan Background Checks Act of 2019 (H.R. 8), from the 116th Congress, which would strengthen the accuracy and reporting of the National Instant Criminal Background Check System (NICS) as well as expand Brady background checks to cover all firearm sales, including unlicensed firearms sellers currently not required to use background checks, and the Gun Violence Prevention Research Act (H.R. 674/S. 184), from the 116th Congress, which would authorize funding for the Centers for Disease Control and Prevention (CDC) to study firearms safety and gun violence prevention. Also urged Congress to pass the Violence Against Women (VAWA) Reauthorization Act of 2021, which passed the House in 2021, to provide protections for domestic violence victims by restricting access to firearms by those deemed a threat to them. Also urged Congress to pass the Assault Weapons Ban of 2019 (S. 66/H.R. 1296), from the 116th Congress, to ban the sale of semi-automatic weapons and high-capacity magazines. Urged support for the enactment of extreme risk protection orders (ERPO) to allow families and law enforcement to obtain a ruling from an impartial judge within 72 hours to temporarily remove guns from individuals at imminent risk of using them to harm themselves or others, with due process. Immigration: The College advocated against family separation at the U.S. border. Specifically, the College urged support for bills from the 116th Congress such as H.R. 541 - the Keep Families Together Act, which would help ensure that children are not separated from their parents when families unlawfully cross over the border into the United States and would ensure that the Department of Homeland Security would not be able to implement the zero tolerance policy that separated families at the border under the last administration; urged congressional oversight of family separation policies. Also urged that Congress pass H.R. 6, the Dream and Promise Act of 2019, which would provide a pathway to U.S. citizenship for undocumented children who came to the United States due to the action of their parents, also known as Dreamers. Graduate Medical Education: Urged that Congress support medical education training and debt relief for primary care physicians and other specialties facing shortages by passing the following legislation from the 116th Congress: the Resident Physician Shortage Reduction Act of 2019 (S. 348, H.R. 1763), to lift the GME caps as needed to permit training an adequate number of primary care physicians, including internal medicine specialists, and physicians in other specialties facing shortages; passing the Resident Education Deferred Interest Act (H.R. 1554), to save physicians in residency programs thousands of dollars in interest on their loans and help incentivize the opening of practices in underserved areas; pass legislation to combine DGME and IME into a single, more functional payment program, and broaden the GME financing structure to include all payers; support funding for GME/IME and programs within the Veterans Health Administration that provide graduate medical education to ensure that physicians are adequately trained with the skills needed to treat an aging population. Urged Congress to pass the Opioid Workforce Act of 2019 (H.R. 3414), which would provide Medicare support for an additional 1,000 graduate medical education (GME) positions over five years in hospitals that have, or are in the process of establishing, accredited residency programs in addiction medicine, addiction psychiatry, or pain medicine. Urged Congress to pass S. 1203 and H.R. 2441, the What You Can Do For Your Country Act, which would improve and reform the Public Service Loan Forgiveness (PSLF) Program. Vaccines: Urged Congress to pass the Vaccines Act (HR 2862), from the 116th Congress, which would provide federal funding for vaccine hesitancy surveillance at the Centers for Disease Control and Prevention (CDC), and outline a national public messaging campaign informed by this research to help improve vaccination rates. Physician Fee Schedule: Commented to CMS and to Congress to fully implement payment increases for all evaluation and management codes, as finalized by CMS, and as scheduled for implementation on Jan. 1, 2021. Reduce the documentation burden for E/M services by allowing choice of medical decision making or time, and work to develop additional clarity and guidance on acceptable documentation to operationalize these important proposals; examination room desktop computers should be counted as a direct medical equipment cost; care management should be promoted by increasing the values of services like Transitional Care Management (TCM) and Chronic Care Management and implementing Principle Care Management (PCM) codes; require additional survey and review for any requests to increase non-outpatient E/M or other services; work with the physician community prior to finalizing any policy affecting eligibility to participate in the Medicare program; Urged congressional committees of jurisdiction to support: Higher physician work relative value units (RVUs) for new and established office visit codes, leading to increased payments for them, Reduced documentation requirements for office visit codes, which enables physicians to select and document for each visit based on medical decision-making or total time, Expanded and improved payment for care management services. Urged Congress to support waiving budget neutrality, applicable to the calendar year 2021 physician fee schedule. COVID-19: Urged congressional appropriators to provide the highest possible funding level for research, prevention, control, and treatment of illnesses associated with the virus that is commensurate with the public health emergency that the virus represents. Urged the administration to explore regulatory and other actions that would make COVID-19 testing free-of-charge to patients covered by both public and private insurance plans, including ACA-compliant plans offered through the insurance exchanges, and to waive co-pays and deductibles for patients seeing physicians for symptoms that may be indicative of COVID-19 or who are hospitalized for treatment. Urged CMS to utilize a national disaster recovery program that would pay doctors 110% of Medicare rates for caring for uninsured patients who have been infected with SARS-CoV-2. Expressed support to Congress and the administration for a variety of COVID-related bills from the 116th Congress as follows: the Families First Coronavirus Response Act, H.R. 6201, and other stimulus reforms related to COVID-19 including: Emergency paid leave benefits, paid sick days for public health emergencies, coverage of testing for COVID-19, waiving of cost sharing under Medicare, Medicare Advantage, Medicaid, and CHIP, increasing the federal FMAP under Medicaid, providing reimbursement for CPT codes 99441 - 99443, which are telephone evaluation and management services, expediting entrance of international medical graduates who are citizens of other nations (non-US IMGs) into the country and ensuring that lawfully present non-U.S. IMGs are not negatively impacted by the COVID-19 pandemic, funding for physician practices under the Public Health and Social Service Emergency Fund (PHSSEF), providing tax relief, grants, and loans to small and medium size practices impacted by COVID-19, increasing funding for personal protective equipment (PPE), ensuring Medicaid pay parity with Medicare for primary care services; Urged HHS and Congress to make a targeted allocation out of the Provider Relief Fund (PRF) to support primary care physicians and their practices, sufficient to keep their doors open, by offsetting lost revenue from the COVID-19 pandemic, similar to the targeted allocation for rural hospitals; Urged support for the Student Loan Forgiveness for Frontline Health Workers Act, H.R. 6720, introduced May 5, 2020 by Representative Carolyn B. Maloney (D-NY) which would eliminate graduate school debt for healthcare workers, including physicians and medical students, who are providing direct patient care in response to the COVID-19 pandemic; Urged support for H.R. 7059, the Coronavirus Provider Protection Act, which extend liability protections to those who provide care in good faith during the COVID-19 public health emergency (plus a reasonable time, such as 60 days, after the emergency declaration ends), and not in situations of gross negligence or willful misconduct. The College also urged that pay parity between telephone claims and in-person visits and between all telehealth and in-person visits be maintained after the PHE is lifted. This extension-either continued by CMS or mandated by Congress-should last at least through the end of 2021, or until such a time when effective vaccines and treatments are widely available, with an option to extend it even further, or consider making permanent, based on the experience and learnings of patients and physicians who are utilizing these visits. Urged Congress to support a targeted allocation from the Provider Relief Fund specifically for primary care services. Priorities for the Biden Administration: Urged the Biden Administration to identify and appoint physicians to health care leadership positions within his Administration. Implement approval, distribution, and funding of a safe and effective COVID-19 vaccine based on recommendations from the Advisory Committee on Immunization Practices (ACIP). Provide support to physicians and other frontline health care workers, including ensuring access and distribution of personal protective equipment (PPE) to health care workers. Fund COVID-19 testing and contact tracing efforts. Reverse regulations that allow the sale of extended short-term, limited duration plans, association health plans. Take action to defend the Affordable Care Act from any litigation, including California v. Texas, that would undermine coverage and patient protections. Expand premium tax credits and cost-sharing reductions. Establish a federal public option to inject competition into the health insurance marketplace. Expand Medicaid eligibility and oppose expansion waivers that limit benefits and apply high cost sharing. Permanently increase payment for Medicaid primary care services to the level of Medicare. Restore the Deferred Action for Childhood Arrivals, consistent with a recent ruling from a federal judge, and identify executive actions that can be taken to ensure that it is not vulnerable to being eliminated in the future. Pursue executive actions to preserve the principles of patient autonomy regarding reproductive decision-making rights. Reverse the Title X gag rule and restore funding to family planning clinics. Establish universal access to at least six weeks of paid family and medical leave that is flexible to accommodate care for a diverse array of family structures, including updating the Family Medical and Leave Act to include grandparents or in-laws. Re-introduce and pass the George Floyd Act and other legislation focused on eliminating racism and police violence. Rejoin the Paris Agreement. Telehealth: Urged Congress to continue existing Public Health Emergency flexibilities and waivers-including pay parity for audio-only phone calls-to support making telehealth an ongoing and continued part of medical care now and in the future, allowing time for further evaluation on which ones should be maintained as is, revised or expanded. Urged Congress to permanently extend the policy to waive geographical and originating-site restrictions after the conclusion of the PHE. Urged Congress or CMS to continue to provide flexibility in the Medicare and Medicaid programs for physician practices to reduce or waive cost-sharing requirements for telehealth services, while also making up the difference between these waived copays and the Medicare allowed amount of the service. Urged Congress or CMS to extend the interim policy to allow Remote Patient Monitoring services to be furnished to patients without an established relationship. Urged support for the Temporary Reciprocity to Ensure Access to Treatment Act or the TREAT Act (S. 168/H.R. 708), which would provide temporary licensing reciprocity for telehealth and interstate health care treatment. American Rescue Plan (ARP) Act (H.R. 1319): Urged support for various provisions within the ARP to provide incentives for states to expand Medicaid by temporarily increasing the states base FMAP by five percentage points for two years for states that newly expand Medicaid. Urged support for allowing states, for five years, to extend Medicaid eligibility (and CHIP eligibility) to women for 12 months postpartum. Urged support to require Medicaid coverage of COVID-19 vaccines and treatment without beneficiary cost sharing with vaccines matched at a 100 percent federal medical assistance percentage (FMAP) through one year after the end of the PHE. Urged support for $46 billion to HHS to detect, diagnose, trace, and monitor COVID-19 infections, and for other activities necessary to mitigate the spread of COVID-19. Urged support to subsidize the health coverage of people earning up to 150 percent of the federal poverty level (FPL) under the ACA and those on unemployment insurance for a period of two years. Urged support for waiving VA cost sharing and copayments for medical treatment until September 30, 2021.
2021 · first_quarter · Health Issues
Health issues impacting patients with rare diseases. Rare disease initiatives. Telehealth. Step Therapy. H.R.2279/S.2546: Safe Step Act. Clinical trials. Newborn screening. User Fee Negotiations. Value Based Purchasing. Affordable Care Act (ACA) issues. Affordable Care Act (ACA) enhancements. COVID-19 Related Issues.
Client expense: $200,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
2020 · second_quarter · Health Issues
H.R. 1840/S. 814, the Expanding Access to Diabetes Self-Management Training (DSMT) Act. The Association supports this legislation to reduce barriers and increase the utilization of DSMT, which is a covered benefit under Medicare. (Lobbyists Used: Meghan Riley, Robert Goldsmith) S. 2199/H.R. 4906, The Insulin Price Reduction Act. The ADA supports this legislation which encourages lower insulin prices. (Lobbyists used: Meghan Riley, Rob Goldsmith) H.R. 2279, the Safe Step Act. The ADA supports this legislation which would require group health plans to provide an exceptions process for any medication step therapy protocol. (Lobbyists used: Meghan Riley, Rob Goldsmith) HR 4457, the Chronic Copay Elimination Act. The ADA supports this legislation which will require private health plans to cover preventive services, including screenings and certain medications, with no cost-sharing for people with chronic conditions such as diabetes. (Lobbyists used: Meghan Riley, Rob Goldsmith) HR 3, the Lower Drug Costs Now Act. This bill would require the HHS Secretary to negotiate prices for certain drugs including insulin. The ADA has not endorsed this legislation but does support specific provisions of this bill. (Lobbyists used: Rob Goldsmith, Meghan Riley) S. 2543, the Prescription Drug Pricing Reduction Act. This bill aims to lower the cost of prescription drugs in the Medicare and Medicaid programs and to improve drug pricing transparency. The ADA has not endorsed this legislation but does support specific provisions of this bill. (Lobbyists used: Rob Goldsmith, Meghan Riley) S. 3544, Coronavirus Relief for Seniors and People with Disabilities Act: The ADA supports this legislation which would address critical health and economic needs for older adults, people with disabilities, front-line workers and family caregivers. (Lobbyists used: Rob Goldsmith, Meghan Riley) Issues worked on not yet reflected in legislation: Protecting and strengthening the Affordable Care Act (ACA). The Association supports continued efforts to strengthen and improve the ACA which ensures access to affordable health coverage for people with diabetes. (Lobbyists used: Meghan Riley, Rob Goldsmith) Medicare Diabetes Prevention Program. The Association supports efforts to make CDC-recognized virtual diabetes prevention program (DPP) providers eligible for reimbursement in MDPP. (Lobbyists used: Rob Goldsmith, Meghan Riley) Child Nutrition Reauthorization. The Association supports protecting many programs (Summer Meals, School Breakfast Program, WIC) that are a part of the Healthy and Hunger-Free Kids Act, which was last reauthorized in 2010. (Lobbyists used: Deema Tarazi, Meghan Riley)
| Republican |
| IL |
| Al Green | Democratic | TX |
| Al Lawson, Jr. | Democratic | FL |
| Alan S. Lowenthal | Democratic | CA |
| Albio Sires | Democratic | NJ |
| Alcee L. Hastings | Democratic | FL |
| Ami Bera | Democratic | CA |
| Andy Harris | Republican | MD |
| Andy Kim | Democratic | NJ |
| Andy Levin | Democratic | MI |
| Ann Kirkpatrick | Democratic | AZ |
| Ann M. Kuster | Democratic | NH |
| Ann Wagner | Republican | MO |
| Anthony Gonzalez | Republican | OH |
| Antonio Delgado | Democratic | NY |
| Austin Scott | Republican | GA |
| Betty McCollum | Democratic | MN |
| Bill Posey | Republican | FL |
| Billy Long | Republican | MO |
| Bob Gibbs | Republican | OH |
| Bobby L. Rush | Democratic | IL |
| Bonnie Watson Coleman | Democratic | NJ |
| Brad R. Wenstrup | Republican | OH |
| Brad Sherman | Democratic | CA |
| Brendan F. Boyle | Democratic | PA |
| Brian K. Fitzpatrick | Republican | PA |
| C. A. Dutch Ruppersberger | Democratic | MD |
| Carolyn B. Maloney | Democratic | NY |
| Chellie Pingree | Democratic | ME |
| Chris Pappas | Democratic | NH |
| Chris Stewart | Republican | UT |
| Chrissy Houlahan | Democratic | PA |
| Colin Z. Allred | Democratic | TX |
| Conor Lamb | Democratic | PA |
| Darin LaHood | Republican | IL |
| Darren Soto | Democratic | FL |
| David B. McKinley | Republican | WV |
| David E. Price | Democratic | NC |
| David J. Trone | Democratic | MD |
| David Loebsack | Democratic | IA |
| David P. Joyce | Republican | OH |
| David P. Roe | Republican | TN |
| David Scott | Democratic | GA |
| Derek Kilmer | Democratic | WA |
| Diana DeGette | Democratic | CO |
| Don Young | Republican | AK |
| Donald M. Payne, Jr. | Democratic | NJ |
| Donna E. Shalala | Democratic | FL |
| Dwight Evans | Democratic | PA |
| Ed Case | Democratic | HI |
| Ed Perlmutter | Democratic | CO |
| Eleanor Holmes Norton | Democratic | DC |
| Elise M. Stefanik | Republican | NY |
| Emanuel Cleaver | Democratic | MO |
| F. James Sensenbrenner, Jr. | Republican | WI |
| Gilbert Ray Cisneros, Jr. | Democratic | CA |
| Glenn Grothman | Republican | WI |
| Glenn Thompson | Republican | PA |
| Grace Meng | Democratic | NY |
| Greg Stanton | Democratic | AZ |
| Gregory F. Murphy | Republican | NC |
| Haley M. Stevens | Democratic | MI |
| Harley Rouda | Democratic | CA |
| Henry C. "Hank" Johnson, Jr. | Democratic | GA |
| Jaime Herrera Beutler | Republican | WA |
| James A. Himes | Democratic | CT |
| James Comer | Republican | KY |
| James P. McGovern | Democratic | MA |
| Jamie Raskin | Democratic | MD |
| Jason Crow | Democratic | CO |
| Jefferson Van Drew | Republican | NJ |
| Jenniffer González-Colón | Republican | PR |
| Jerrold Nadler | Democratic | NY |
| Jody B. Hice | Republican | GA |
| Joe Courtney | Democratic | CT |
| Joe Neguse | Democratic | CO |
| John A. Yarmuth | Democratic | KY |
| John B. Larson | Democratic | CT |
| John Garamendi | Democratic | CA |
| John H. Rutherford | Republican | FL |
| John Joyce | Republican | PA |
| John Katko | Republican | NY |
| Joseph P. Kennedy III | Democratic | MA |
| Josh Gottheimer | Democratic | NJ |
| Josh Harder | Democratic | CA |
| Joyce Beatty | Democratic | OH |
| Julia Brownley | Democratic | CA |
| Kathleen M. Rice | Democratic | NY |
| Kendra S. Horn | Democratic | OK |
| Kenny Marchant | Republican | TX |
| Kim Schrier | Democratic | WA |
| Lee M. Zeldin | Republican | NY |
| Lisa Blunt Rochester | Democratic | DE |
| Lizzie Fletcher | Democratic | TX |
| Lloyd Smucker | Republican | PA |
| Lucy McBath | Democratic | GA |
| Madeleine Dean | Democratic | PA |
| Mark E. Amodei | Republican | NV |
| Mark E. Green | Republican | TN |
| Mark Pocan | Democratic | WI |
| Mark Takano | Democratic | CA |
| Mary Gay Scanlon | Democratic | PA |
| Max Rose | Democratic | NY |
| Michael F. Doyle | Democratic | PA |
| Michael Guest | Republican | MS |
| Michael R. Turner | Republican | OH |
| Michael Waltz | Republican | FL |
| Mikie Sherrill | Democratic | NJ |
| Nanette Diaz Barragán | Democratic | CA |
| Neal P. Dunn | Republican | FL |
| Nydia M. Velázquez | Democratic | NY |
| Patrick T. McHenry | Republican | NC |
| Paul A. Gosar | Republican | AZ |
| Paul Tonko | Democratic | NY |
| Pete Aguilar | Democratic | CA |
| Peter A. DeFazio | Democratic | OR |
| Peter J. Visclosky | Democratic | IN |
| Peter T. King | Republican | NY |
| Raja Krishnamoorthi | Democratic | IL |
| Raúl M. Grijalva | Democratic | AZ |
| Rick W. Allen | Republican | GA |
| Robert E. Latta | Republican | OH |
| Robert J. Wittman | Republican | VA |
| Robin L. Kelly | Democratic | IL |
| Roger Marshall | Republican | KS |
| Ron Kind | Democratic | WI |
| Ross Spano | Republican | FL |
| Ruben Gallego | Democratic | AZ |
| Sean Patrick Maloney | Democratic | NY |
| Seth Moulton | Democratic | MA |
| Sharice Davids | Democratic | KS |
| Stephanie N. Murphy | Democratic | FL |
| Stephen F. Lynch | Democratic | MA |
| Steve Chabot | Republican | OH |
| Steve Cohen | Democratic | TN |
| Steve Stivers | Republican | OH |
| Steve Womack | Republican | AR |
| Steven M. Palazzo | Republican | MS |
| Susan Wild | Democratic | PA |
| Suzan K. DelBene | Democratic | WA |
| TJ Cox | Democratic | CA |
| Ted Budd | Republican | NC |
| Ted Lieu | Democratic | CA |
| Terri A. Sewell | Democratic | AL |
| Tom Cole | Republican | OK |
| Tom Malinowski | Democratic | NJ |
| Tulsi Gabbard | Democratic | HI |
| Vicente Gonzalez | Democratic | TX |
| W. Gregory Steube | Republican | FL |
| William R. Keating | Democratic | MA |
| Wm. Lacy Clay | Democratic | MO |
| Xochitl Torres Small | Democratic | NM |
| Yvette D. Clarke | Democratic | NY |
| Zoe Lofgren | Democratic | CA |
Client expense: $170,367 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), President of the U.S., SENATE, State, Dept of (DOS)
Client expense: $92,741 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), President of the U.S., SENATE, State, Dept of (DOS)
Client expense: $120,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
2020 · fourth_quarter · Health Issues
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; The Patient Affordability, Value and Efficiency Act (not yet introduced); Discussions related to co-pay accumulators; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Client expense: $420,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · third_quarter · Health Issues
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Client expense: $1,190,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2020 · third_quarter · Health Issues
H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill to amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions H.R 748/S. 3548, Coronavirus Aid, Relief and Economic Security Act (CARES Act), regarding all bio-pharmaceutical provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, regarding all bio-pharmaceutical related provisions
Client expense: $1,600,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2020 · third_quarter · Copyright/Patent/Trademark
H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions
Client expense: $1,600,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2020 · second_quarter · Health Issues
H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill to amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions H.R 748/S. 3548, Coronavirus Aid, Relief and Economic Security Act (CARES Act), regarding all bio-pharmaceutical provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, regarding all bio-pharmaceutical related provisions
Client expense: $2,160,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2020 · second_quarter · Copyright/Patent/Trademark
H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions
Client expense: $2,160,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2020 · second_quarter · Health Issues
H.R. 1840/S. 814, the Expanding Access to Diabetes Self-Management Training (DSMT) Act. The Association supports this legislation to reduce barriers and increase the utilization of DSMT, which is a covered benefit under Medicare. (Lobbyists Used: Meghan Riley, Robert Goldsmith) S. 2199/H.R. 4906, The Insulin Price Reduction Act. The ADA supports this legislation which encourages lower insulin prices. (Lobbyists used: Meghan Riley, Rob Goldsmith) H.R. 2279, the Safe Step Act. The ADA supports this legislation which would require group health plans to provide an exceptions process for any medication step therapy protocol. (Lobbyists used: Meghan Riley, Rob Goldsmith) HR 4457, the Chronic Copay Elimination Act. The ADA supports this legislation which will require private health plans to cover preventive services, including screenings and certain medications, with no cost-sharing for people with chronic conditions such as diabetes. (Lobbyists used: Meghan Riley, Rob Goldsmith) HR 3, the Lower Drug Costs Now Act. This bill would require the HHS Secretary to negotiate prices for certain drugs including insulin. The ADA has not endorsed this legislation but does support specific provisions of this bill. (Lobbyists used: Rob Goldsmith, Meghan Riley) S. 2543, the Prescription Drug Pricing Reduction Act. This bill aims to lower the cost of prescription drugs in the Medicare and Medicaid programs and to improve drug pricing transparency. The ADA has not endorsed this legislation but does support specific provisions of this bill. (Lobbyists used: Rob Goldsmith, Meghan Riley) S. 3544, Coronavirus Relief for Seniors and People with Disabilities Act: The ADA supports this legislation which would address critical health and economic needs for older adults, people with disabilities, front-line workers and family caregivers. (Lobbyists used: Rob Goldsmith, Meghan Riley) Issues worked on not yet reflected in legislation: Protecting and strengthening the Affordable Care Act (ACA). The Association supports continued efforts to strengthen and improve the ACA which ensures access to affordable health coverage for people with diabetes. (Lobbyists used: Meghan Riley, Rob Goldsmith) Medicare Diabetes Prevention Program. The Association supports efforts to make CDC-recognized virtual diabetes prevention program (DPP) providers eligible for reimbursement in MDPP. (Lobbyists used: Rob Goldsmith, Meghan Riley) Child Nutrition Reauthorization. The Association supports protecting many programs (Summer Meals, School Breakfast Program, WIC) that are a part of the Healthy and Hunger-Free Kids Act, which was last reauthorized in 2010. (Lobbyists used: Deema Tarazi, Meghan Riley)
Client expense: $120,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
2020 · first_quarter · Health Issues
H.R. 1840/S. 814, the Expanding Access to Diabetes Self-Management Training (DSMT) Act. The Association supports this legislation to reduce barriers and increase the utilization of DSMT, which is a covered benefit under Medicare. (Lobbyists Used: Meghan Riley, Robert Goldsmith) S. 2199/H.R. 4906, The Insulin Price Reduction Act. The ADA supports this legislation which encourages lower insulin prices. (Lobbyists used: Meghan Riley, Rob Goldsmith) H.R. 2279, the Safe Step Act. The ADA supports this legislation which would require group health plans to provide an exceptions process for any medication step therapy protocol. (Lobbyists used: Meghan Riley, Rob Goldsmith) HR 4457, the Chronic Copay Elimination Act. The ADA supports this legislation which will require private health plans to cover preventive services, including screenings and certain medications, with no cost-sharing for people with chronic conditions such as diabetes. (Lobbyists used: Meghan Riley, Rob Goldsmith) HR 3, the Lower Drug Costs Now Act. This bill would require the HHS Secretary to negotiate prices for certain drugs including insulin. The ADA has not endorsed this legislation but does support specific provisions of this bill. (Lobbyists used: Rob Goldsmith, Meghan Riley) S. 2543, the Prescription Drug Pricing Reduction Act. This bill aims to lower the cost of prescription drugs in the Medicare and Medicaid programs and to improve drug pricing transparency. The ADA has not endorsed this legislation but does support specific provisions of this bill. (Lobbyists used: Rob Goldsmith, Meghan Riley) S. 3544, Coronavirus Relief for Seniors and People with Disabilities Act: The ADA supports this legislation which would address critical health and economic needs for older adults, people with disabilities, front-line workers and family caregivers. (Lobbyists used: Rob Goldsmith, Meghan Riley) Issues worked on not yet reflected in legislation: Protecting and strengthening the Affordable Care Act (ACA). The Association supports continued efforts to strengthen and improve the ACA which ensures access to affordable health coverage for people with diabetes. (Lobbyists used: Meghan Riley, Rob Goldsmith) Medicare Diabetes Prevention Program. The Association supports efforts to make CDC-recognized virtual diabetes prevention program (DPP) providers eligible for reimbursement in MDPP. (Lobbyists used: Rob Goldsmith, Meghan Riley) Child Nutrition Reauthorization. The Association supports protecting many programs (Summer Meals, School Breakfast Program, WIC) that are a part of the Healthy and Hunger-Free Kids Act, which was last reauthorized in 2010. (Lobbyists used: Deema Tarazi, Meghan Riley)
Client expense: $80,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
2020 · fourth_quarter · Health Issues
H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill to amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions H.R 748/S. 3548, Coronavirus Aid, Relief and Economic Security Act (CARES Act), regarding all bio-pharmaceutical provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, regarding all bio-pharmaceutical related provisions
Client expense: $1,090,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2020 · fourth_quarter · Copyright/Patent/Trademark
H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions H.R. 133, the Consolidated Appropriations Act of 2021, regarding all bio-pharmaceutical related provisions
Client expense: $1,090,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2020 · fourth_quarter · Health Issues
Issues surrounding the enactment or repeal of the Affordable Care Act. Medicare reimbursement reform for providers including the Medicare Access and CHIP Reauthorization Act (MACRA). Medicare Part B Drug Reimbursement. FDA issues. The Palliative Care and Hospice Education and Training Act. Draft legislation to reform the FDA's regulation of cosmetics. Legislation to address physician workforce shortage (HR 1763/S.348). Ensuring Lasting Smiles Act (HR 1379/S. 560). Legislation to address out-of-network medical bills: HR 3630, HR 3502, HR 861, S.1895, S. 1531. Improving Seniors Access to Timely Care Act, HR 3107, Safe Step Act, HR 2279. Removing Barriers to Colorectal Cancer Screening Act of 2019, HR 1570. Financial relief and policy and regulatory changes for the provider community in COVID-19 legislation including the CARES Act. Regulation of Organ Procurement Networks (OPOs).
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
Cancer Drug Parity Act (HR 1740/S 741) Safe Step Act (HR 2279/S 2546) Mitigating Emergency Drug Shortages Act (S 2723/HR 6080) Palliative Care Hospice Education and Training Act (HR 647/S 2080) The Prescription Drug Pricing Reduction Act (S 2543) Access to Infertility Treatment and Care Act (HR 2308/S 1461)
Client expense: $85,311 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
Health issues impacting patients with rare diseases. Telehealth. Step Therapy. H.R.2279/S.2546: Safe Step Act. Notice of Benefit Payment Parameters. Surprise Medical Billing. Pre-Existing Conditions. User Fee Negotiations. Physician Fee Schedule. Value Based Purchasing. Integrated Review Panel. Regulation and Guidance Reform. Affordable Care Act. COVID-19 Related Issues.
Client expense: $60,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2020 · fourth_quarter · Budget/Appropriations
Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare Reimbursement. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response to the outbreak. Monitoring and outreach on legislative activity related to the HEALS Act (S. 4317 - S. 4324). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). House Draft, Department of Defense Appropriations Act, FY 2021. Senate Draft, Department of Defense Appropriations Act, FY 2021. H.R. 3, Lower Drug Costs Now Act of 2019. H.R.748, CARES Act (P.L. 116-136) and other legislation related to the policies in reaction to the national health crisis. H.R.7010, Paycheck Protection Program Flexibility Act of 2020 (P.L. 116-142). H.R. 1158, FY2020 Consolidated Appropriations Act (Defense, CJS, FSGG, Homeland Security). H.R. 1554, REDI Act. H.R. 2087, To amend title XVIII of the Social Security Act to require certain manufacturers to report drug pricing information with respect to drugs under the Medicare program, and for other purposes. H.R. 2279, Safe Step Act. H.R. 2693, To amend title XVIII of the Social Security Act to improve access to, and utilization of, bone mass measurement benefits under part B of the Medicare program by establishing a minimum payment amount under such part for bone mass measurement. H.R. 2781, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness for Health Act of 2019. H.R. 3107, Improving Seniors' Timely Access to Care Act of 2019. H.R. 4378, FY2020 Continuing Appropriations Resolution (P.L. 116-59). S. 64, Preserve Access to Affordable Generics and Biosimilars Act. S. 283, Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019. S. 1391, Fair Accountability and Innovative Research Drug Pricing Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. S. 2546, Safe Step Act. H.R. 1763, Resident Physician Shortage Reduction Act. S. 348, Resident Physician Shortage Reduction Act. H.R. 6788, Workforce Resilience Act. S. 3599, Workforce Resilience Act. H.R. 5741, Strengthening Innovation in Medicare and Medicaid Act. H.R. 8505, To amend title XVIII of the Social Security Act to provide for a one-year waiver of budget neutrality adjustments under the Medicare physician fee schedule, and for other purposes H.R. 8702, Holding Providers Harmless From Medicare Cuts During COVID-19 Act of 2020 H.R. 6644/S. 3741, Health Care at Home Act H.R. 4932/S. 2741, The Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act H.R. 266, Paycheck Protection Program and Health Care Enhancement Act (P.L. 116-139). S. 4014, The Prioritized Paycheck Protection Program (P4) Act. S. 4116, A bill to extend the authority for commitments for the paycheck protection program and separate amounts authorized for other loans under section 7(a) of the Small Business Act, and for other purposes (P.L. 116-147). S.4775, Delivering Immediate Relief to America's Families, Schools and Small Businesses Act. H.R. 6800, The Heroes Act. H.R. 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act (P.L. 116-159). P.L. 116-260, FY2021 Omnibus and COVID Relief and Response Act. H.R. 133: Consolidated Appropriations Act, 2021.
Client expense: $100,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · fourth_quarter · Health Issues
Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare Reimbursement. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response to the outbreak. Monitoring and outreach on legislative activity related to the HEALS Act (S. 4317 - S. 4324). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). House Draft, Department of Defense Appropriations Act, FY 2021. Senate Draft, Department of Defense Appropriations Act, FY 2021. H.R. 3, Lower Drug Costs Now Act of 2019. H.R.748, CARES Act (P.L. 116-136) and other legislation related to the policies in reaction to the national health crisis. H.R.7010, Paycheck Protection Program Flexibility Act of 2020 (P.L. 116-142). H.R. 1158, FY2020 Consolidated Appropriations Act (Defense, CJS, FSGG, Homeland Security). H.R. 1554, REDI Act. H.R. 2087, To amend title XVIII of the Social Security Act to require certain manufacturers to report drug pricing information with respect to drugs under the Medicare program, and for other purposes. H.R. 2279, Safe Step Act. H.R. 2693, To amend title XVIII of the Social Security Act to improve access to, and utilization of, bone mass measurement benefits under part B of the Medicare program by establishing a minimum payment amount under such part for bone mass measurement. H.R. 2781, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness for Health Act of 2019. H.R. 3107, Improving Seniors' Timely Access to Care Act of 2019. H.R. 4378, FY2020 Continuing Appropriations Resolution (P.L. 116-59). S. 64, Preserve Access to Affordable Generics and Biosimilars Act. S. 283, Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019. S. 1391, Fair Accountability and Innovative Research Drug Pricing Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. S. 2546, Safe Step Act. H.R. 1763, Resident Physician Shortage Reduction Act. S. 348, Resident Physician Shortage Reduction Act. H.R. 6788, Workforce Resilience Act. S. 3599, Workforce Resilience Act. H.R. 5741, Strengthening Innovation in Medicare and Medicaid Act. H.R. 8505, To amend title XVIII of the Social Security Act to provide for a one-year waiver of budget neutrality adjustments under the Medicare physician fee schedule, and for other purposes H.R. 8702, Holding Providers Harmless From Medicare Cuts During COVID-19 Act of 2020 H.R. 6644/S. 3741, Health Care at Home Act H.R. 4932/S. 2741, The Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act H.R. 266, Paycheck Protection Program and Health Care Enhancement Act (P.L. 116-139). S. 4014, The Prioritized Paycheck Protection Program (P4) Act. S. 4116, A bill to extend the authority for commitments for the paycheck protection program and separate amounts authorized for other loans under section 7(a) of the Small Business Act, and for other purposes (P.L. 116-147). S.4775, Delivering Immediate Relief to America's Families, Schools and Small Businesses Act. H.R. 6800, The Heroes Act. H.R. 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act (P.L. 116-159). P.L. 116-260, FY2021 Omnibus and COVID Relief and Response Act. H.R. 133: Consolidated Appropriations Act, 2021.
Client expense: $100,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · fourth_quarter · Medicare/Medicaid
Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare Reimbursement. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response to the outbreak. Monitoring and outreach on legislative activity related to the HEALS Act (S. 4317 - S. 4324). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). House Draft, Department of Defense Appropriations Act, FY 2021. Senate Draft, Department of Defense Appropriations Act, FY 2021. H.R. 3, Lower Drug Costs Now Act of 2019. H.R.748, CARES Act (P.L. 116-136) and other legislation related to the policies in reaction to the national health crisis. H.R.7010, Paycheck Protection Program Flexibility Act of 2020 (P.L. 116-142). H.R. 1158, FY2020 Consolidated Appropriations Act (Defense, CJS, FSGG, Homeland Security). H.R. 1554, REDI Act. H.R. 2087, To amend title XVIII of the Social Security Act to require certain manufacturers to report drug pricing information with respect to drugs under the Medicare program, and for other purposes. H.R. 2279, Safe Step Act. H.R. 2693, To amend title XVIII of the Social Security Act to improve access to, and utilization of, bone mass measurement benefits under part B of the Medicare program by establishing a minimum payment amount under such part for bone mass measurement. H.R. 2781, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness for Health Act of 2019. H.R. 3107, Improving Seniors' Timely Access to Care Act of 2019. H.R. 4378, FY2020 Continuing Appropriations Resolution (P.L. 116-59). S. 64, Preserve Access to Affordable Generics and Biosimilars Act. S. 283, Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019. S. 1391, Fair Accountability and Innovative Research Drug Pricing Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. S. 2546, Safe Step Act. H.R. 1763, Resident Physician Shortage Reduction Act. S. 348, Resident Physician Shortage Reduction Act. H.R. 6788, Workforce Resilience Act. S. 3599, Workforce Resilience Act. H.R. 5741, Strengthening Innovation in Medicare and Medicaid Act. H.R. 8505, To amend title XVIII of the Social Security Act to provide for a one-year waiver of budget neutrality adjustments under the Medicare physician fee schedule, and for other purposes H.R. 8702, Holding Providers Harmless From Medicare Cuts During COVID-19 Act of 2020 H.R. 6644/S. 3741, Health Care at Home Act H.R. 4932/S. 2741, The Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act H.R. 266, Paycheck Protection Program and Health Care Enhancement Act (P.L. 116-139). S. 4014, The Prioritized Paycheck Protection Program (P4) Act. S. 4116, A bill to extend the authority for commitments for the paycheck protection program and separate amounts authorized for other loans under section 7(a) of the Small Business Act, and for other purposes (P.L. 116-147). S.4775, Delivering Immediate Relief to America's Families, Schools and Small Businesses Act. H.R. 6800, The Heroes Act. H.R. 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act (P.L. 116-159). P.L. 116-260, FY2021 Omnibus and COVID Relief and Response Act. H.R. 133: Consolidated Appropriations Act, 2021.
Client expense: $100,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · fourth_quarter · Medicare/Medicaid
Issues related to prescription drug coverage and pharmacy benefits H.R.803/S.988: Improving Transparency and Accuracy in Medicare Part D Spending Act H.R.1034/S.640: Phair Pricing Act of 2019 H.R.1035: Prescription Drug Price Transparency Act H.R.5800: Ban Surprise Billing Act S.2543: Prescription Drug Pricing Reduction Act S.2247: Phair Relief Act Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits H.R.19/S.3129: Lower Costs More Cures Act H.R.2279/S.2546: Safe Step Act H.R.3: Lower Drug Costs Now Act H.R. 6557 MAIL Act S.3384: Lowering Prescription Drug Prices for America's Seniors and Families Act S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act Executive Order on An America-First Healthcare Plan Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees Prescription drug pricing transparency H.R.1264/S.801: Payment Commission Data Act H.R.223/S.532: PBM Study Act H.R.1781: Payment Commission Data Act H.R.2113: Prescription Drug Sunshine, Transparency, Accountability and Reporting Act H.R.2115: Public Disclosure of Drug Discounts Act H.R.5304: PBM Transparency in Prescription Drug Costs Act H.R.133: Consolidated Appropriations Act, 2021 S.476: C-THRU Act S.2543: Prescription Drug Pricing Reduction Act Access to prescription drugs during the coronavirus pandemic H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R.6557: MAIL Act H.R.6800: HEROES Act Generic and biosimilar utilization H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes
Client expense: $2,000,785 · 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), SENATE
2020 · fourth_quarter · Health Issues
Issues related to prescription drug coverage and pharmacy benefits H.R.803/S.988: Improving Transparency and Accuracy in Medicare Part D Spending Act H.R.1034/S.640: Phair Pricing Act of 2019 H.R.1035: Prescription Drug Price Transparency Act H.R.5800: Ban Surprise Billing Act S.2543: Prescription Drug Pricing Reduction Act S.2247: Phair Relief Act S.1895: Lower Health Care Costs Act Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market Prescription drug pricing transparency H.R.1264/S.801: Payment Commission Data Act H.R.2376/S.1227: Prescription Pricing for the People Act H.R.3223/S.1532 PBM Study Act H.R.1781: Payment Commission Data Act H.R.2113: Prescription Drug Sunshine, Transparency, Accountability and Reporting Act H.R.2115: Public Disclosure of Drug Discounts Act H.R.5304: PBM Transparency in Prescription Drug Costs Act H.R.133: Consolidated Appropriations Act, 2021 S.476: C-THRU Act S.2543: Prescription Drug Pricing Reduction Act S.657: Drug Price Transparency Act S.977: Transparent Drug Pricing Act Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits H.R.19/S.3129:Lower Costs More Cures Act H.R.2279/S.2546: Safe Step Act H.R.6557: MAIL Act H.R.3: Lower Drug Costs Now Act S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act S.3384: Lowering Prescription Drug Prices for America's Seniors and Families Act Executive Order on An America-First Healthcare Plan Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees Access to prescription drugs during the coronavirus pandemic H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R.6557 MAIL Act H.R.6800: HEROES Act Generic and biosimilar utilization H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes (McKinley) Issues related to prescription drug patents and approval process H.R.938: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act H.R.985: Fair Access for Safe and Timely (FAST) Generics Act H.R.1499: Protecting Consumer Access to Generic Drugs Act H.R.1520: Purple Book Continuity Act H.R.1503: Orange Book Transparency Act S.64: Preserve Access to Affordable Generics and Biosimilars Act S.659: Biologic Patent Transparency Act Issues related to coverage of prescription drugs in the commercial market H.R.5304: PBM Transparency in Prescription Drug Costs Act H.R.5800: Ban Surprise Billing Act S.657: Drug Price Transparency Act S.977: Transparent Drug Pricing Act S.1895: Lower Health Care Costs Act
Client expense: $2,000,785 · 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), SENATE
2020 · fourth_quarter · Health Issues
HR 6663, Truth in Health Care Marketing Act P.L. 111-148 Affordable Care Act, modifications: 1. Reducing regulatory/costly burdens on medical practices - relief from regulatory burdens 2. Preserving patient access to office ancillary testing services Meaningful Use/EHR program issues P.L. 113-54, Drug Quality & Security Act, all sections Medicare Advantage plan network adequacy Prior authorization utilization policies Medicare Part B Drug Price Issues Medicare Access and CHIP Reauthorization Act (P.L. 114-10) Implementation Issues Proposed Contact Lens Rule Modifications Medicare Physician Payment Issues Drug Pricing and Shortages Issues S. 2020, SEE MORE ACT Vision Research Funding Medical Surprise Billing Legislative proposals HR 3107, Improving Seniors' Timely Access to Care Act HR 3975, Contact Lens Prescription Verification Modernization Act S. 4613, Contact Lens Rule Modernization Act HR 2279/S.2546, Safe Step Act HR 4665, The Medicare Vision Act HR 3, Elijah Cummings Lower Drug Cost Now Act Coronavirus Pandemic Relief Measures HR 6365/S.3559 Immediate Relief for Rural Facilities and Providers Act HR 7059, Coronavirus Provider Protection Act HR 2620, Faster Treatments and Cures for Eye Diseases Act HR 7819, Eliminating the Provider Relief Fund Tax Penalties Act S. 4295, Public Health Emergency Pass-Through Payment Fairness Act HR 8624, Protecting Access to Innovation During COVID-19 Act S.4932, the Medicare Reimbursement Equity Act HR 8702/S. 5007, the Holding Providers Harmless From Medicare Cuts During COVID-19 Act HR 8505, a bill to waive budget neutrality requirements of the Medicare Physician Fee Schedule H.R. 8709, the Analyzing Kinetic Impact Projectiles (KIPs) Against Americans Act
Client expense: $210,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · fourth_quarter · Health Issues
-H.R. 6420 / S. 3652 All Dependents Count Act, support passage. -H.R. 6680 / S. 3619 Strengthening Unemployment Insurance for Coronavirus Impacted Workers and Students Act, support passage. -H.R. 6305 / S. 3544 Coronavirus Relief for Seniors and People with Disabilities, support passage. -H.R. 2279/S. 2546, Safe Step Act, support passage-H.R. 3630, No Surprises Act; S. 1895, Lower Health Care Costs Act; S. 1531, the Stopping the Outrageous Practice of Surprise Medical Bills Act of 2019; H.R. 5800, Ban Surprise Billing Act; H.R. 5826 Consumer Protections Against Surprise Medical Bills Act, support passage of legislation to protect patients from surprise medical billing that holds patients harmless-H.R. 2093/S. 1028, STATES Act, support passage-H.R. 127, Compassionate Access, Research Expansion and Respect States (CARERS) Act, support passage- H.R. 4322/S. 2400, Expanding Cannabis Research and Information Act, support passage -H.R. 1425, Patient Protection and Affordable Care Enhancement Act, support passage. -H.R. 133, Consolidated Appropriations Act, support funding for epilepsy programs and research, COVID-19 relief and ending surprise medical billing.
Client expense: $50,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
The Safe Step Act, H.R. 2279; Surprise Billing Legislation, in general; Stopping The Outrageous Practice of Surprise Medical Bills Act of 2019, S. 1531; Protecting People From Surprise Medical Bills Act, H.R. 3502; No Surprises Act, H.R. 3630; Lower Health Care Costs Act, S.1895; COVID-19 regulatory changes in general; Coronavirus Preparedness and Response Supplemental Appropriations (CPRSA) Act, the Families First Coronavirus Response Act (FFCRA), and the Coronavirus Aid, Relief, and Economic Security (CARES) Act - issues impacting GI patients, physicians and ambulatory surgery centers; H.R. 266/P.L. 116-139, the Paycheck Protection Program and Health Care Enhancement Act - provisions related to Public Health and Social Services Emergency Fund to provide further relief to physician practices.
Client expense: Not reported · Firm income: $50,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · fourth_quarter · Health Issues
S. 474, Stop the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act; H.R. 447 / S. 97, Affordable and Safe Prescription Drug Importation Act; S. 61 / H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 102 / H.R. 465, Prescription Drug Price Relief Act of 2019; H.R.1478, Affordable Insulin Act of 2019; S. 3, Keeping Health Insurance Affordable Act of 2019; H.R 965 / S. 340, CREATES Act of 2019; H.R. 1332, Fair Care Act of 2019; S. 637, CURE High Drug Prices Act; H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019; S. 657, A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits; S. 709, Prescription Drug Pricing Dashboard Act; S. 977, Transparent Drug Pricing Act of 2019; S. 1895, Lower Health Care Costs Act; H.R. 2296, FAIR Drug Pricing Act of 2019; H.R. 3947, the Competition Prescription Act of 2019; H.R. 2279, the Safe Step Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; S. 2543, the Prescription Drug Pricing Reduction Act of 2019; H.R. 19 / S. 3129, the Lower Costs, More Cures Act of 2019; S. 4199, the Prescription Drug Pricing Reduction Act of 2020
Client expense: $330,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office
Discussions regarding drug pricing and supply chain issues, rare diseases, gene therapy and value based arrangements; biosimilar support; Alzheimer's policy, PET scan coverage and reimbursement, and dementia care Appropriations on Alzheimers screening and diagnosis Support for H.R.1520/S.1895 codifying the Purple Book Discussions regarding S.2546/H.R.2279, the Safe Step Act, patient access issues Support for H.R.6179 directing CMS to implement a shared savings model for biosimilars
Client expense: $890,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Insurance
H.R. 3165 / S. 1737, the Mental Health Parity Compliance Act; Medicare Mental Health Inpatient Equity Act H.R. 2279/ S. 2546, the Safe Step Act H.R. 3630, the No Surprises Act H.R. 2874/ S. 1576, the Behavioral Health Coverage Transparency Act of 2019 H.R. 3107, the Improving Seniors Timely Access to Care Act Efforts to increase compliance with the Mental Health Parity and Addiction Equity Act of 2008.
Client expense: $238,000 · Firm income: Not reported
Government targets: Bureau of Citizenship & Immigration Services (BCIS), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of the Vice President of the United States, SENATE, Veterans Affairs, Dept of (VA), White House Office
2020 · fourth_quarter · Health Issues
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; The Patient Affordability, Value and Efficiency Act (not yet introduced); Discussions related to co-pay accumulators; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Client expense: $410,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · fourth_quarter · Medicare/Medicaid
Access to Care and Treatment issues (including step therapy, prior authorization, non-medical switching - including HR 3107 - Improving Seniors Timely Access to Care Act and HR 2279/S.2546 Safe Step Act) Medicare Part D Protected Class Drugs
Client expense: $40,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
2020 · fourth_quarter · Health Issues
Mental Health issues (incl. 21st Cures Act implementation, mental health parity - incl. H.R.3165/S.1737 Mental Health Parity Compliance Act and H.R.2848 Parity Enforcement Act) General Health Care issues (including Medicare/Medicaid, pre-existing conditions coverage) Medicare Part D Protected Class Drugs coverage Research, Medical and Scientific Issues (including BRAIN initiative) H.R.1131/S.4583 - The Collaborative Academic Research Efforts (CARE) for Tourette Syndrome Act 21st Century Cures Act Implementation (including National Neurological Conditions Surveillance System) Access to Care and Treatment issues (including step therapy, prior authorization, non-medical switching - including HR 3107 - Improving Seniors Timely Access to Care Act, HR 2279/S.2546 Safe Step Act) Drug pricing broadly Suicide Prevention (HR 419/S.2661 - The National Suicide Hotline Designation Act, S.1782/H.R.3192 - Improving Mental Health Access for Students) Telehealth - increased coverage including making public health emergency coverage for telehealth permanent (including S.2741/H.R.4932 - CONNECT for Health Act, H.R.7663 - Protecting Access to Post-COVID-19 Telehealth Act of 2020)
Client expense: $40,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
2020 · fourth_quarter · Health Issues
S. 348/H.R. 1763 Resident Physician Shortage Reduction Act of 2019; all provisions. S. 2443: Investment in Tomorrow's Pediatric Health Care Workforce Act; all provisions. S. 2546 / H.R. 2279: Safe Step Act; all provisions. S. 3599/H.R. 6788: Healthcare Workforce Resilience Act; all provisions. S. 3741/ H.R. 6644: The Health Care at Home Act; all provisions. S. 3993: The Equal Access to Care Act; all provisions. S. 4421/ H.R. 8283: the Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act. S. 7819/H.R. 4525 Eliminating the Provider Relief Fund Tax Penalties Act of 2020; all provisions. H.R.133: The Consolidated Appropriations Act, 2021, Division H Title II Department of Health and Human Services; Division BB, Titles I, No Surprises Act. H.R. 2781: Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness (EMPOWER) for Health Act, section 4. H.R. 3502: Protecting People from Surprise Medical Bills Act; all provisions. H.R. 6800: The Heroes Act; Title VI and Title X Division C. H.R. 7059: The Coronavirus Provider Protection Act; all provisions. H.R. 7255: Coronavirus Health Care Worker Wellness Act of 2020; all provisions. Supporting policies to address the COVID-19 public health emergency, including funding for personal protective equipment, maintaining telemedicine coverage, ensuring access to affordable health coverage, and medical liability flexibility relating to COVID-19. Funding for the CDC National Neurological Conditions Surveillance System. Medical research funding related to fetal tissue, AHRQ, and the NIH including the BRAIN Initiative. Funding for Congressionally Directed Medical Research Programs at the DoD. Policy to address surprise medical billing. Promoting interoperability in electronic health records. Maintain work authorization for individuals currently in DACA status during the COVID-19 national emergency and other policies to support health care providers who live, work, and train in the United States but are not US citizens.
Client expense: $180,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
H.R. 2279 and S. 2546, Safe Step Act; general issues pertaining to prescription drug costs; general issues pertaining to mental health; issues related to plasma-derived therapies for the treatment of COVID-19 patients; H.R. 4439, Creating Hope Reauthorization Act; H.R. 7839, Continuing Access to In- Home IVIG Act; Consolidated Appropriations Act of 2021, provision relating to extension of Medicare patient IVIG access demonstration project.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
The Affordable Care Act (P.L. 111-148, P.L. 111-152): 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; Advocated against a December 2018 ruling by a federal judge in Texas that the entire Affordable Care Act (ACA) is unconstitutional. 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. 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. Medicare Payments to Physicians: Urged that Congress provide incentives to physicians who transform their practices into Advanced Alternative Payment Models and continue to provide stability for physicians in the MIPS program. Specifically, Congress should extend the five percent Qualified Alternative Payment Model participant bonus beyond the 2022 performance year, replace the zero percent baseline payment updates under Medicare with positive updates. Urged congressional committees with jurisdiction over Medicare to exercise their oversight authority and urge CMS to expedite approval of more Advanced APMS, particularly those that work for small and specialty practices and to simplify the scoring structure and reporting requirements under the Merit-Based Incentive Payment System (MIPS) in order to fulfill Congress intent of a more streamlined program that reduces burdens on physicians; Supported S.2648, the Rural ACO Improvement Act, amends title XVIII of the Social Security Act to improve the benchmarking process for the Medicare Shared Savings Program (MSSP) to ensure that all ACOs have an equal opportunity to share in savings regardless of their geographic location; Provided recommendations to CMS on the Merit-based Incentive Payment System Value Pathway (MVP), which aims to reduce reporting burden and complexity within MIPS while improving the accuracy and effectiveness of performance measurement. The College noted specifically that a robust, multi-year transition period will be critical to the success of the MVP, that it does not support making the MVP mandatory, that CMS should continue to support numerous reporting mechanisms, including qualified registries and clinical data registries, which have been instrumental in developing specialty-specific performance measures, among other things. Urged support for H.R. 8505, a bill to provide for a one-year waiver of budget neutrality adjustments under the Medicare physician fee schedule; Urged that any legislation to hold some Medicare physician payment codes harmless from budget neutrality do so for just one year and to allow evaluation and management increases, along with GPC1X codes to go into effect. Administrative Tasks on Physicians and Patients: Congress should accelerate its efforts to reduce administrative burdens on clinicians and patients, including: streamlining the prior authorization process, better integrating clinical data into clinicians electronic health records (EHRs), and working with CMS in their effort to overhaul clinical documentation guidelines; Urged Congress to cosponsor and pass the Safe Step Act (H.R. 2279), to require health insurers to provide an exceptions process for any medication step therapy protocol based on clinical decision-making, medical necessity, and other patient needs. Prescription Drug Costs: The College advocated for greater transparency in drug pricing, the elimination of anti-competitive industry practices that create barriers to generics coming to market, the importance of accounting for value in payment and coverage for prescriptions, and providing authority to the federal government to negotiate drug discounts under the Medicare Part D program. Specifically, the College urged Congress to pass the Medicare Prescription Drug Price Negotiation Act of 2019 (H.R. 275/S. 62), which allows the Secretary of Health and Human Services to negotiate covered Part D drug prices on behalf of Medicare beneficiaries, and the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, (H.R. 965/S. 340), 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. Also urged that Congress pass the Reforming Evergreening and Manipulation that Extends Drug Years, REMEDY Act (S. 1209), to aid in the approval of more generic drug applications by the FDA and therefore improve patient access to those medications. Also urged that Congress pass the Prescription Drug STAR Act (H.R. 2113), and the Fair Accountability and Innovative Research (FAIR) Drug Pricing Act (H.R. 2296/S. 1391), to promote greater drug pricing transparency; Expressed appreciation to the House speaker for introduction of H.R. 3, the Lower Drug Costs Now Act, noting encouragement for its provisions to empower the Secretary of Health and Human Services (HHS) to negotiate with drug companies for lower prices and to cap out-of-pocket costs for seniors enrolled in the Medicare Part D program. Commented to the FDA on its prescription drug reimportation proposed rule noting that while the College is generally supportive of drug importation as laid out in the proposed rule as a means to control the cost of prescription drugs, the FDA must guarantee that the design and implementation of the rule includes numerous measures and safeguards to ensure patient safety. By limiting the origin of imported drugs to Canadian-certified and FDA-approved and registered drugs and entities, the College believes the proposed rule meets the required U.S. standards to assure high-quality drugs and patient safety. Any final drug importation system must also be one that is a closed system and has a tightly controlled and documented supply chain to assure authenticity and avoid degradation of the drug. Workforce, Medical and Health Services Research, Public Health Initiatives: Congress should ensure funding in FY 2021 for federal programs/initiatives designed to support primary care including Title VII Health Professions grants and the National Health Service Corps (NHSC). Equally important is the need to fund essential health services and medical research by the Agency for Healthcare Research and Quality (AHRQ) and the National Institutes of Health (NIH) and public health programs supported by the Centers for Disease Control and Prevention (CDC). Firearms-Related Injury and Death: The College advocated for lawmakers to pass measures to strengthen the criminal background check system, ban assault weapons and high capacity magazines, prevent the unlawful transfer of firearms to those who cannot legally purchase them, and remove restrictions on, and provide dedicated funding for, research by federal agencies on prevention of firearms-related injuries and death. Specifically, the College urged passage of the Bipartisan Background Checks Act of 2019 (H.R. 8), which would strengthen the accuracy and reporting of the National Instant Criminal Background Check System (NICS) as well as expand Brady background checks to cover all firearm sales, including unlicensed firearms sellers currently not required to use background checks, and the Gun Violence Prevention Research Act (H.R. 674/S. 184), which would authorize funding for the Centers for Disease Control and Prevention (CDC) to study firearms safety and gun violence prevention. Also urged Congress to pass the Violence Against Women (VAWA) Reauthorization Act of 2019 (H.R. 1585), to provide protections for domestic violence victims by restricting access to firearms by those deemed a threat to them. Also urged Congress to pass the Assault Weapons Ban of 2019 (S. 66/H.R. 1296), to ban the sale of semi-automatic weapons and high capacity magazines. Immigration: The College advocated against family separation at the U.S. border. Specifically, the College urged support for H.R. 541 - the Keep Families Together Act, which would help ensure that children are not separated from their parents when families unlawfully cross over the border into the United States and would ensure that the Department of Homeland Security would not be able to implement the zero tolerance policy that separated families at the border last summer; urged congressional oversight of family separation policies. Also urged that Congress pass H.R. 6, the Dream and Promise Act of 2019, which would provide a pathway to U.S. citizenship for undocumented children who came to the United States due to the action of their parents, also known as Dreamers. Expressed concern to the U.S. Department of Homeland Security with the recent U.S. Citizenship and Immigration Service (USCIS) policy change to no longer accept or adjudicate non-military deferred action requests including those for individuals with serious medical conditions; Urged USCIS to reverse this decision immediately and resume consideration of deferred action requests for medical reasons; Opposed the proposed rule, U.S. Immigration and Customs Enforcement (ICE) Establishing a Fixed Time Period of Admission and an Extension of Stay Procedure for Nonimmigrant Academic Students, Exchange Visitors, and Representatives of Foreign Information Media. This rule would change the process to extend the period of authorized stay in the United States for certain categories of nonimmigrants by eliminating the long-standing "duration of status and replacing it with a specific end date. The College urged the Department of Homeland Security to exclude physicians in the Department of States (DOS) Exchange Visitor Program in J-1 visa status from this rule change because it will otherwise disrupt the training of thousands of physicians - physicians who already have been thoroughly vetted, already are serving on our nations health care teams, and already are carefully monitored during their time in the U.S. Graduate Medical Education: Urged that Congress support medical education training and debt relief for primary care physicians and other specialties facing shortages by passing the Resident Physician Shortage Reduction Act of 2019 (S. 348, H.R. 1763), to lift the GME caps as needed to permit training an adequate number of primary care physicians, including internal medicine specialists, and physicians in other specialties facing shortages; passing the Resident Education Deferred Interest Act (H.R. 1554), to save physicians in residency programs thousands of dollars in interest on their loans and help incentivize the opening of practices in underserved areas; pass legislation to combine DGME and IME into a single, more functional payment program, and broaden the GME financing structure to include all payers; support funding for GME/IME and programs within the Veterans Health Administration that provide graduate medical education to ensure that physicians are adequately trained with the skills needed to treat an aging population. Urged Congress to pass the Opioid Workforce Act of 2019 (H.R. 3414), which would provide Medicare support for an additional 1,000 graduate medical education (GME) positions over five years in hospitals that have, or are in the process of establishing, accredited residency programs in addiction medicine, addiction psychiatry, or pain medicine. Urged Congress to pass S. 1203 and H.R. 2441, the What You Can Do For Your Country Act, which would improve and reform the Public Service Loan Forgiveness (PSLF) Program. Vaccines: Urged Congress to pass the Vaccines Act (HR 2862), which would provide federal funding for vaccine hesitancy surveillance at the Centers for Disease Control and Prevention (CDC), and outline a national public messaging campaign informed by this research to help improve vaccination rates; Supported H.R. 592, recognizing the anniversary of the eradication of smallpox and the importance of vaccination in the United States and worldwide; Urged the U.S. Department of Homeland Security (DHS) to reconsider its decision to not vaccinate families in the custody of U.S. Customs and Border Protection (CBP) against influenza (flu). Urged Congress to support payments for vaccines, as finalized by CMS, and set for implementation on Jan. 1, 2021. Surprise Medical Billing: Urged Congress to pass legislation that would protect patients from surprise out-of-network medical bills in both emergency and non-emergency settings that includes the following principles: hold patients harmless from surprise medical bills for out-of-network services, address narrow insurance networks, abandon efforts to establish an in-network median rate for services in these settings and instead opt for an independent dispute resolution process to determine payment. Appropriations: Urged Congress to fund Title VII, Section 747, Primary Care Training and Enhancement (PCTE) at $71 million for fiscal year 2021; Fund the Agency for Health Care Research and Quality (AHRQ) at $460 million for fiscal year 2021; Fund the National Health Service Corps (NHSC) at $830 million for fiscal year 2021; Fund the Title X Family Planning Program at $400 million for fiscal year 2021 and include language to remove barriers to care that interfere with the patient-physician relationship; Fund Research on Prevention of Firearms-related Injuries and Deaths at $50 million for Fiscal Year 2021; Fund the National Institutes of Health (NIH) at $44.7 billion for fiscal year 2021; Fund the Centers for Disease Control and Prevention (CDC) at $8.3 billion for fiscal year 2021; Urged the House and Senate Armed Services Committees to support provisions in any final FY2021 National Defense Authorization Act to prevent cuts to the Military Health Service and the military medical workforce without requiring appropriate congressional oversight and review. Physician Fee Schedule: Commented to CMS and to Congress to fully implement payment increases for all evaluation and management codes, as finalized by CMS, and as scheduled for implementation on Jan. 1, 2021. Reduce the documentation burden for E/M services by allowing choice of medical decision making or time, and work to develop additional clarity and guidance on acceptable documentation to operationalize these important proposals; examination room desktop computers should be counted as a direct medical equipment cost; care management should be promoted by increasing the values of services like Transitional Care Management (TCM) and Chronic Care Management and implementing Principle Care Management (PCM) codes; require additional survey and review for any requests to increase non-outpatient E/M or other services; work with the physician community prior to finalizing any policy affecting eligibility to participate in the Medicare program; Urged congressional committees of jurisdiction to support: Higher physician work relative value units (RVUs) for new and established office visit codes, leading to increased payments for them, Reduced documentation requirements for office visit codes, which enables physicians to select and document for each visit based on medical decision-making or total time, Expanded and improved payment for care management services. Urged Congress to support waiving budget neutrality, applicable to the calendar year 2021 physician fee schedule. COVID-19: Urged congressional appropriators to provide the highest possible funding level for research, prevention, control, and treatment of illnesses associated with the virus that is commensurate with the public health emergency that the virus represents. Urged the administration to explore regulatory and other actions that would make COVID-19 testing free-of-charge to patients covered by both public and private insurance plans, including ACA-compliant plans offered through the insurance exchanges, and to waive co-pays and deductibles for patients seeing physicians for symptoms that may be indicative of COVID-19 or who are hospitalized for treatment. Urged CMS to utilize a national disaster recovery program that would pay doctors 110% of Medicare rates for caring for uninsured patients who have been infected with SARS-CoV-2. Expressed support to Congress and the administration for the Families First Coronavirus Response Act, H.R. 6201, and other stimulus reforms related to COVID-19 including: Emergency paid leave benefits, paid sick days for public health emergencies, coverage of testing for COVID-19, waiving of cost sharing under Medicare, Medicare Advantage, Medicaid, and CHIP, increasing the federal FMAP under Medicaid, providing reimbursement for CPT codes 99441 - 99443, which are telephone evaluation and management services, expediting entrance of international medical graduates who are citizens of other nations (non-US IMGs) into the country and ensuring that lawfully present non-U.S. IMGs are not negatively impacted by the COVID-19 pandemic, funding for physician practices under the Public Health and Social Service Emergency Fund (PHSSEF), providing tax relief, grants, and loans to small and medium size practices impacted by COVID-19, increasing funding for personal protective equipment (PPE), ensuring Medicaid pay parity with Medicare for primary care services; Urged HHS and Congress to make a targeted allocation out of the Provider Relief Fund (PRF) to support primary care physicians and their practices, sufficient to keep their doors open, by offsetting lost revenue from the COVID-19 pandemic, similar to the targeted allocation for rural hospitals; Urged support for the Student Loan Forgiveness for Frontline Health Workers Act, H.R. 6720, introduced May 5, 2020 by Representative Carolyn B. Maloney (D-NY) which would eliminate graduate school debt for healthcare workers, including physicians and medical students, who are providing direct patient care in response to the COVID-19 pandemic; Urged support for H.R. 7059, the Coronavirus Provider Protection Act, which extend liability protections to those who provide care in good faith during the COVID-19 public health emergency (plus a reasonable time, such as 60 days, after the emergency declaration ends), and not in situations of gross negligence or willful misconduct. The College also urged that pay parity between telephone claims and in-person visits and between all telehealth and in-person visits be maintained after the PHE is lifted. This extension-either continued by CMS or mandated by Congress-should last at least through the end of 2021, or until such a time when effective vaccines and treatments are widely available, with an option to extend it even further, or consider making permanent, based on the experience and learnings of patients and physicians who are utilizing these visits. Urged Congress to support a targeted allocation from the Provider Relief Fund specifically for primary care services. Priorities for New Administration: Urged the incoming Biden Administration to identify and appoint physicians to health care leadership positions within your Administration. Implement approval, distribution, and funding of a safe and effective COVID-19 vaccine based on recommendations from the Advisory Committee on Immunization Practices (ACIP). Provide support to physicians and other frontline health care workers, including ensuring access and distribution of personal protective equipment (PPE) to health care workers. Fund COVID-19 testing and contact tracing efforts. Reverse regulations that allow the sale of extended short-term, limited duration plans, association health plans. Take action to defend the Affordable Care Act from any litigation, including California v. Texas, that would undermine coverage and patient protections. Expand premium tax credits and cost-sharing reductions. Establish a federal public option to inject competition into the health insurance marketplace. Expand Medicaid eligibility and oppose expansion waivers that limit benefits and apply high cost sharing. Permanently increase payment for Medicaid primary care services to the level of Medicare. Restore the Deferred Action for Childhood Arrivals, consistent with a recent ruling from a federal judge, and identify executive actions that can be taken to ensure that it is not vulnerable to being eliminated in the future. Pursue executive actions to preserve the principles of patient autonomy regarding reproductive decision-making rights. Reverse the Title X gag rule and restore funding to family planning clinics. Establish universal access to at least six weeks of paid family and medical leave that is flexible to accommodate care for a diverse array of family structures, including updating the Family Medical and Leave Act to include grandparents or in-laws. Re-introduce and pass the George Floyd Act and other legislation focused on eliminating racism and police violence. Rejoin the Paris Agreement.
Client expense: $241,204 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), President of the U.S., SENATE, State, Dept of (DOS)
2020 · fourth_quarter · Health Issues
The Affordable Care Act (P.L. 111-148, P.L. 111-152): 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; Advocated against a December 2018 ruling by a federal judge in Texas that the entire Affordable Care Act (ACA) is unconstitutional. 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. 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. Medicare Payments to Physicians: Urged that Congress provide incentives to physicians who transform their practices into Advanced Alternative Payment Models and continue to provide stability for physicians in the MIPS program. Specifically, Congress should extend the five percent Qualified Alternative Payment Model participant bonus beyond the 2022 performance year, replace the zero percent baseline payment updates under Medicare with positive updates. Urged congressional committees with jurisdiction over Medicare to exercise their oversight authority and urge CMS to expedite approval of more Advanced APMS, particularly those that work for small and specialty practices and to simplify the scoring structure and reporting requirements under the Merit-Based Incentive Payment System (MIPS) in order to fulfill Congress intent of a more streamlined program that reduces burdens on physicians; Supported S.2648, the Rural ACO Improvement Act, amends title XVIII of the Social Security Act to improve the benchmarking process for the Medicare Shared Savings Program (MSSP) to ensure that all ACOs have an equal opportunity to share in savings regardless of their geographic location; Provided recommendations to CMS on the Merit-based Incentive Payment System Value Pathway (MVP), which aims to reduce reporting burden and complexity within MIPS while improving the accuracy and effectiveness of performance measurement. The College noted specifically that a robust, multi-year transition period will be critical to the success of the MVP, that it does not support making the MVP mandatory, that CMS should continue to support numerous reporting mechanisms, including qualified registries and clinical data registries, which have been instrumental in developing specialty-specific performance measures, among other things. Urged support for H.R. 8505, a bill to provide for a one-year waiver of budget neutrality adjustments under the Medicare physician fee schedule; Urged that any legislation to hold some Medicare physician payment codes harmless from budget neutrality do so for just one year and to allow evaluation and management increases, along with GPC1X codes to go into effect. Administrative Tasks on Physicians and Patients: Congress should accelerate its efforts to reduce administrative burdens on clinicians and patients, including: streamlining the prior authorization process, better integrating clinical data into clinicians electronic health records (EHRs), and working with CMS in their effort to overhaul clinical documentation guidelines; Urged Congress to cosponsor and pass the Safe Step Act (H.R. 2279), to require health insurers to provide an exceptions process for any medication step therapy protocol based on clinical decision-making, medical necessity, and other patient needs. Prescription Drug Costs: The College advocated for greater transparency in drug pricing, the elimination of anti-competitive industry practices that create barriers to generics coming to market, the importance of accounting for value in payment and coverage for prescriptions, and providing authority to the federal government to negotiate drug discounts under the Medicare Part D program. Specifically, the College urged Congress to pass the Medicare Prescription Drug Price Negotiation Act of 2019 (H.R. 275/S. 62), which allows the Secretary of Health and Human Services to negotiate covered Part D drug prices on behalf of Medicare beneficiaries, and the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, (H.R. 965/S. 340), 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. Also urged that Congress pass the Reforming Evergreening and Manipulation that Extends Drug Years, REMEDY Act (S. 1209), to aid in the approval of more generic drug applications by the FDA and therefore improve patient access to those medications. Also urged that Congress pass the Prescription Drug STAR Act (H.R. 2113), and the Fair Accountability and Innovative Research (FAIR) Drug Pricing Act (H.R. 2296/S. 1391), to promote greater drug pricing transparency; Expressed appreciation to the House speaker for introduction of H.R. 3, the Lower Drug Costs Now Act, noting encouragement for its provisions to empower the Secretary of Health and Human Services (HHS) to negotiate with drug companies for lower prices and to cap out-of-pocket costs for seniors enrolled in the Medicare Part D program. Commented to the FDA on its prescription drug reimportation proposed rule noting that while the College is generally supportive of drug importation as laid out in the proposed rule as a means to control the cost of prescription drugs, the FDA must guarantee that the design and implementation of the rule includes numerous measures and safeguards to ensure patient safety. By limiting the origin of imported drugs to Canadian-certified and FDA-approved and registered drugs and entities, the College believes the proposed rule meets the required U.S. standards to assure high-quality drugs and patient safety. Any final drug importation system must also be one that is a closed system and has a tightly controlled and documented supply chain to assure authenticity and avoid degradation of the drug. Workforce, Medical and Health Services Research, Public Health Initiatives: Congress should ensure funding in FY 2021 for federal programs/initiatives designed to support primary care including Title VII Health Professions grants and the National Health Service Corps (NHSC). Equally important is the need to fund essential health services and medical research by the Agency for Healthcare Research and Quality (AHRQ) and the National Institutes of Health (NIH) and public health programs supported by the Centers for Disease Control and Prevention (CDC). Firearms-Related Injury and Death: The College advocated for lawmakers to pass measures to strengthen the criminal background check system, ban assault weapons and high capacity magazines, prevent the unlawful transfer of firearms to those who cannot legally purchase them, and remove restrictions on, and provide dedicated funding for, research by federal agencies on prevention of firearms-related injuries and death. Specifically, the College urged passage of the Bipartisan Background Checks Act of 2019 (H.R. 8), which would strengthen the accuracy and reporting of the National Instant Criminal Background Check System (NICS) as well as expand Brady background checks to cover all firearm sales, including unlicensed firearms sellers currently not required to use background checks, and the Gun Violence Prevention Research Act (H.R. 674/S. 184), which would authorize funding for the Centers for Disease Control and Prevention (CDC) to study firearms safety and gun violence prevention. Also urged Congress to pass the Violence Against Women (VAWA) Reauthorization Act of 2019 (H.R. 1585), to provide protections for domestic violence victims by restricting access to firearms by those deemed a threat to them. Also urged Congress to pass the Assault Weapons Ban of 2019 (S. 66/H.R. 1296), to ban the sale of semi-automatic weapons and high capacity magazines. Immigration: The College advocated against family separation at the U.S. border. Specifically, the College urged support for H.R. 541 - the Keep Families Together Act, which would help ensure that children are not separated from their parents when families unlawfully cross over the border into the United States and would ensure that the Department of Homeland Security would not be able to implement the zero tolerance policy that separated families at the border last summer; urged congressional oversight of family separation policies. Also urged that Congress pass H.R. 6, the Dream and Promise Act of 2019, which would provide a pathway to U.S. citizenship for undocumented children who came to the United States due to the action of their parents, also known as Dreamers. Expressed concern to the U.S. Department of Homeland Security with the recent U.S. Citizenship and Immigration Service (USCIS) policy change to no longer accept or adjudicate non-military deferred action requests including those for individuals with serious medical conditions; Urged USCIS to reverse this decision immediately and resume consideration of deferred action requests for medical reasons; Opposed the proposed rule, U.S. Immigration and Customs Enforcement (ICE) Establishing a Fixed Time Period of Admission and an Extension of Stay Procedure for Nonimmigrant Academic Students, Exchange Visitors, and Representatives of Foreign Information Media. This rule would change the process to extend the period of authorized stay in the United States for certain categories of nonimmigrants by eliminating the long-standing "duration of status and replacing it with a specific end date. The College urged the Department of Homeland Security to exclude physicians in the Department of States (DOS) Exchange Visitor Program in J-1 visa status from this rule change because it will otherwise disrupt the training of thousands of physicians - physicians who already have been thoroughly vetted, already are serving on our nations health care teams, and already are carefully monitored during their time in the U.S. Graduate Medical Education: Urged that Congress support medical education training and debt relief for primary care physicians and other specialties facing shortages by passing the Resident Physician Shortage Reduction Act of 2019 (S. 348, H.R. 1763), to lift the GME caps as needed to permit training an adequate number of primary care physicians, including internal medicine specialists, and physicians in other specialties facing shortages; passing the Resident Education Deferred Interest Act (H.R. 1554), to save physicians in residency programs thousands of dollars in interest on their loans and help incentivize the opening of practices in underserved areas; pass legislation to combine DGME and IME into a single, more functional payment program, and broaden the GME financing structure to include all payers; support funding for GME/IME and programs within the Veterans Health Administration that provide graduate medical education to ensure that physicians are adequately trained with the skills needed to treat an aging population. Urged Congress to pass the Opioid Workforce Act of 2019 (H.R. 3414), which would provide Medicare support for an additional 1,000 graduate medical education (GME) positions over five years in hospitals that have, or are in the process of establishing, accredited residency programs in addiction medicine, addiction psychiatry, or pain medicine. Urged Congress to pass S. 1203 and H.R. 2441, the What You Can Do For Your Country Act, which would improve and reform the Public Service Loan Forgiveness (PSLF) Program. Vaccines: Urged Congress to pass the Vaccines Act (HR 2862), which would provide federal funding for vaccine hesitancy surveillance at the Centers for Disease Control and Prevention (CDC), and outline a national public messaging campaign informed by this research to help improve vaccination rates; Supported H.R. 592, recognizing the anniversary of the eradication of smallpox and the importance of vaccination in the United States and worldwide; Urged the U.S. Department of Homeland Security (DHS) to reconsider its decision to not vaccinate families in the custody of U.S. Customs and Border Protection (CBP) against influenza (flu). Urged Congress to support payments for vaccines, as finalized by CMS, and set for implementation on Jan. 1, 2021. Surprise Medical Billing: Urged Congress to pass legislation that would protect patients from surprise out-of-network medical bills in both emergency and non-emergency settings that includes the following principles: hold patients harmless from surprise medical bills for out-of-network services, address narrow insurance networks, abandon efforts to establish an in-network median rate for services in these settings and instead opt for an independent dispute resolution process to determine payment. Appropriations: Urged Congress to fund Title VII, Section 747, Primary Care Training and Enhancement (PCTE) at $71 million for fiscal year 2021; Fund the Agency for Health Care Research and Quality (AHRQ) at $460 million for fiscal year 2021; Fund the National Health Service Corps (NHSC) at $830 million for fiscal year 2021; Fund the Title X Family Planning Program at $400 million for fiscal year 2021 and include language to remove barriers to care that interfere with the patient-physician relationship; Fund Research on Prevention of Firearms-related Injuries and Deaths at $50 million for Fiscal Year 2021; Fund the National Institutes of Health (NIH) at $44.7 billion for fiscal year 2021; Fund the Centers for Disease Control and Prevention (CDC) at $8.3 billion for fiscal year 2021; Urged the House and Senate Armed Services Committees to support provisions in any final FY2021 National Defense Authorization Act to prevent cuts to the Military Health Service and the military medical workforce without requiring appropriate congressional oversight and review. Physician Fee Schedule: Commented to CMS and to Congress to fully implement payment increases for all evaluation and management codes, as finalized by CMS, and as scheduled for implementation on Jan. 1, 2021. Reduce the documentation burden for E/M services by allowing choice of medical decision making or time, and work to develop additional clarity and guidance on acceptable documentation to operationalize these important proposals; examination room desktop computers should be counted as a direct medical equipment cost; care management should be promoted by increasing the values of services like Transitional Care Management (TCM) and Chronic Care Management and implementing Principle Care Management (PCM) codes; require additional survey and review for any requests to increase non-outpatient E/M or other services; work with the physician community prior to finalizing any policy affecting eligibility to participate in the Medicare program; Urged congressional committees of jurisdiction to support: Higher physician work relative value units (RVUs) for new and established office visit codes, leading to increased payments for them, Reduced documentation requirements for office visit codes, which enables physicians to select and document for each visit based on medical decision-making or total time, Expanded and improved payment for care management services. Urged Congress to support waiving budget neutrality, applicable to the calendar year 2021 physician fee schedule. COVID-19: Urged congressional appropriators to provide the highest possible funding level for research, prevention, control, and treatment of illnesses associated with the virus that is commensurate with the public health emergency that the virus represents. Urged the administration to explore regulatory and other actions that would make COVID-19 testing free-of-charge to patients covered by both public and private insurance plans, including ACA-compliant plans offered through the insurance exchanges, and to waive co-pays and deductibles for patients seeing physicians for symptoms that may be indicative of COVID-19 or who are hospitalized for treatment. Urged CMS to utilize a national disaster recovery program that would pay doctors 110% of Medicare rates for caring for uninsured patients who have been infected with SARS-CoV-2. Expressed support to Congress and the administration for the Families First Coronavirus Response Act, H.R. 6201, and other stimulus reforms related to COVID-19 including: Emergency paid leave benefits, paid sick days for public health emergencies, coverage of testing for COVID-19, waiving of cost sharing under Medicare, Medicare Advantage, Medicaid, and CHIP, increasing the federal FMAP under Medicaid, providing reimbursement for CPT codes 99441 - 99443, which are telephone evaluation and management services, expediting entrance of international medical graduates who are citizens of other nations (non-US IMGs) into the country and ensuring that lawfully present non-U.S. IMGs are not negatively impacted by the COVID-19 pandemic, funding for physician practices under the Public Health and Social Service Emergency Fund (PHSSEF), providing tax relief, grants, and loans to small and medium size practices impacted by COVID-19, increasing funding for personal protective equipment (PPE), ensuring Medicaid pay parity with Medicare for primary care services; Urged HHS and Congress to make a targeted allocation out of the Provider Relief Fund (PRF) to support primary care physicians and their practices, sufficient to keep their doors open, by offsetting lost revenue from the COVID-19 pandemic, similar to the targeted allocation for rural hospitals; Urged support for the Student Loan Forgiveness for Frontline Health Workers Act, H.R. 6720, introduced May 5, 2020 by Representative Carolyn B. Maloney (D-NY) which would eliminate graduate school debt for healthcare workers, including physicians and medical students, who are providing direct patient care in response to the COVID-19 pandemic; Urged support for H.R. 7059, the Coronavirus Provider Protection Act, which extend liability protections to those who provide care in good faith during the COVID-19 public health emergency (plus a reasonable time, such as 60 days, after the emergency declaration ends), and not in situations of gross negligence or willful misconduct. The College also urged that pay parity between telephone claims and in-person visits and between all telehealth and in-person visits be maintained after the PHE is lifted. This extension-either continued by CMS or mandated by Congress-should last at least through the end of 2021, or until such a time when effective vaccines and treatments are widely available, with an option to extend it even further, or consider making permanent, based on the experience and learnings of patients and physicians who are utilizing these visits. Urged Congress to support a targeted allocation from the Provider Relief Fund specifically for primary care services. Priorities for New Administration: Urged the incoming Biden Administration to identify and appoint physicians to health care leadership positions within your Administration. Implement approval, distribution, and funding of a safe and effective COVID-19 vaccine based on recommendations from the Advisory Committee on Immunization Practices (ACIP). Provide support to physicians and other frontline health care workers, including ensuring access and distribution of personal protective equipment (PPE) to health care workers. Fund COVID-19 testing and contact tracing efforts. Reverse regulations that allow the sale of extended short-term, limited duration plans, association health plans. Take action to defend the Affordable Care Act from any litigation, including California v. Texas, that would undermine coverage and patient protections. Expand premium tax credits and cost-sharing reductions. Establish a federal public option to inject competition into the health insurance marketplace. Expand Medicaid eligibility and oppose expansion waivers that limit benefits and apply high cost sharing. Permanently increase payment for Medicaid primary care services to the level of Medicare. Restore the Deferred Action for Childhood Arrivals, consistent with a recent ruling from a federal judge, and identify executive actions that can be taken to ensure that it is not vulnerable to being eliminated in the future. Pursue executive actions to preserve the principles of patient autonomy regarding reproductive decision-making rights. Reverse the Title X gag rule and restore funding to family planning clinics. Establish universal access to at least six weeks of paid family and medical leave that is flexible to accommodate care for a diverse array of family structures, including updating the Family Medical and Leave Act to include grandparents or in-laws. Re-introduce and pass the George Floyd Act and other legislation focused on eliminating racism and police violence. Rejoin the Paris Agreement.
Client expense: $91,236 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), President of the U.S., SENATE, State, Dept of (DOS)
2020 · fourth_quarter · Health Issues
HR 1010 Short Term Limited Duration Policies Oversight of ACA Implementation MHPAEA compliance and enforcement HR 2279 - Safe Step Act
Client expense: $17,154 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Housing & Urban Development, Dept of (HUD), Labor, Dept of (DOL), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA)
2020 · fourth_quarter · Copyright/Patent/Trademark
H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions H.R. 133, the Consolidated Appropriations Act of 2021, regarding all bio-pharmaceutical related provisions
Client expense: $1,090,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2020 · fourth_quarter · Health Issues
H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill to amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions H.R 748/S. 3548, Coronavirus Aid, Relief and Economic Security Act (CARES Act), regarding all bio-pharmaceutical provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, regarding all bio-pharmaceutical related provisions
Client expense: $1,090,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2020 · fourth_quarter · Health Issues
S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3, Lower Drug Costs Now Act of 2019; Issues concerning BARDA funding; S. 551, Recovering Excessive Funds for Unused and Needless Drugs Act 2019; Drug importation including S. 61 and H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 97 and H.R. 447, Affordable and Safe Prescription Drug Importation Act; Legislation affecting pharmaceutical pricing including the Lower Heath Care Costs Act of 2019 (S.1895), Affordable Prescriptions for Patients Act of 2019 (S. 1416), Fair Accountability and Innovative Research Drug Pricing Act of 2019 (S. 1391, Transparent Drug Pricing Act of 2019 (S. 977), CREATES Act of 2019 (H.R. 965, S. 340), Medicare Negotiation and Competitive Licensing Act of 2019 (H.R. 1046), Strengthening Health Care and Lowering Prescription Drug Costs Act (H.R. 987). Policies impacting the U.S. response to the COVID-19 pandemic including H.R. 604, the Coronavirus Preparedness and Response Supplemental Appropriations Act, Public Law No. 116-123; H.R. 6201, Families First Coronavirus Response Act, Public Law No. 116-127; H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act"), Public Law No. 116-136; and H.R. 6800, the Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act"). H.R. 2279/S.2546, the Safe Step Act. Policies to ensure an adequate supply of plasma generally and for the development of therapies for COVID-19. Education regarding Executive Orders impacting drug pricing including Medicare rebate reform, the 340B drug discount program, Buy America requirements, drug importation, and imposition of most favored nation pricing on drugs under Medicare Parts B and D. Legislation to increase awareness of need for plasma donations including H.R. 7783/S. 4179, the Plasma Donation Awareness Act of 2020. H.R. 133, Consolidated Appropriations Act, 2021, Pub. L. No. 116-260.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
Step Therapy Reform - H.R. 2279 & S. 2546 The Safe Step Act Mental Health - H.R. 2519 The Improving Mental Health Access from the Emergency Department Act of 2019 Mental Health - H.R 7080 the Stopping the Mental Health Pandemic Act Mental Health - H.R. 7159 the Crisis Care Improvement and Suicide Prevention Act of 2020 Mental Health - H.R. 4861 the Effective Suicide Screening and Assessment in the Emergency Department Act of 2019 Mental Health - S.2661 - National Suicide Hotline Designation Act of 2020 Rule - REMOVAL OF SAFE HARBOR PROTECTION FOR REBATES INVOLVING PRESCRIPTION PHARMACEUTICALS AND CREATION OF NEW SAFE HARBOR PROTECTION FOR CERTAIN POINT-OF-SALE REDUCTIONS IN PRICE ON PRESCRIPTION PHARMACEUTICALS AND CERTAIN PHARMACY BENEFIT MANAGER SERVICE FEES Rule - Importation of Prescription Drugs Mental Health - H.R. 133 The Consolidated Appropriations Act of 2021
Client expense: $90,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
- Title VII, Public Health Service Act - Biosimilars - Surprise Medical Billing - H.R. 3630 No Surprises Act - H.R. 133 Consolidated Appropriations Act - H.R. 2279 / S. 2546, Safe Step Act of 2019 - S. 1895, Lower Health Care Costs Act - H.R 3, Lower Drug Costs Now Act of 2019 - H.R. 748, the CARES Act - S. 2496 and H.R. 4386' Stop the Wait Act - H.R. 7647
Client expense: $75,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, Veterans Affairs, Dept of (VA)
2020 · fourth_quarter · Health Issues
H.R. 2279, S. 2546 - Safe Step Act and issues related to step therapy. Membership in the Crohn's & Colitis Congressional Caucus.
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE
2020 · fourth_quarter · Health Issues
Safe Step Act; S. 2546/H.R. 2279 Expanding Cannabis Research & Information Act; S. 2400/H.R. 4522 Patients Protection in Healthcare
Client expense: Not reported · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE
2020 · fourth_quarter · Health Issues
Safe Step Act HR 2279/S. 2546 Telehealth Expansion HR 6644 COVID Relief for Physicians: HR 6720, HR 7059, HR 2895/S. 948, HR 6788/S. 3599, HR 7077/S. 3877
Client expense: $80,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · second_quarter · Health Issues
Lobbied in support of HR 2279, the Safe Step Act, legislation that will provide a clear and transparent appeals process for physicians to appeal a step therapy protocol on behalf of their patients. Lobbied in support of S. 2546, Safe Step Act. Lobbied in support of legislation to address surprise billing, specifically that provide an independent dispute resolution for physicians. Lobbied in support of federal assistance for physicians and physician practices impacted by the pandemic.
Client expense: $80,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Health Issues
Safe Step Act HR2279/S2546
Client expense: $70,000 · 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), SENATE
2020 · second_quarter · Health Issues
H.R. 965, S. 340 - Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019: Issues regarding processes by which generic manufacturers can obtain sufficient quantities of brand drug samples for testing. H.R. 3253 - Empowering Beneficiaries, Ensuring Access, and Strengthening Accountability Act of 2019: Regarding all provisions. S. 1895 - The Lower Health Care Costs Act: Issues related to rural health access; health equity; Medicare Advantage; Medicaid Rebates; Medicaid Expansion; Rate Notice and Call Letter; Medicare Part D; NBPP, Part D Donut Hole; Privacy; Universal Coverage. H.R. 861 - End Surprise Billing Act, H.R. 3630 - No Surprises Act, H.R. 3502 - Protecting People from Surprise Medical Bills Act, H.R. 5800 - Ban Surprise Billing Act, H.R. 5826 - Consumer Protections Against Surprise Medical Bills Act of 2020: Issues related to surprise billing, including benchmark payments, arbitration models, and out of network billing. S. 916 - MOMMAs Act, H.R. 2602, S. 1343 - MOMMIES Act: Issues related to options for states to extend coverage for pregnant women eligible for Medicaid via the pregnancy pathway to 365 days, Minority Maternity Care, Social Determinants of Health. S. 657 - Drug Price Transparency (DPT) Act, S. 2543 - Prescription Drug Pricing Reduction Act of 2019: Issues related to drug and price transparency. H.R. 3- Lower Drug Costs Now Act of 2019, S. 102 - Prescription Drug Pricing Reduction Act of 2019: Issues related to drug costs and prescription rebates. H.R. 19 - Lower Costs, More Cures Act of 2019: Issues related to prescription drug pricing S. 2546, H.R.2279 - Safe Step Act: Issues related to managed care, prior authorization. S. 3374 - Protecting Jessica Grubb's Legacy Act: Issues regarding HIPPA, confidentiality of substance abuse records H.R. 6139 - Health Care Protection Act: Issues related to COVID-19, funding for surveillance testing and treatment, financial assistance for individual health insurance, COBRA, financial assistance to maintain employer health plan coverage, and emergency funding for hospitals and providers. H.R. 6800 - HEROES ACT: Issues related to COVID-19, Federal Medical Assistance Percentages, Medicaid and COBRA. H.R. 1425 - Patient Protection and Affordable Care Enhancement ACT: Issues related to COVID-19, Medicaid expansion, and prescription drugs. Issues related to drug and price transparency, including the Administrations rule on interoperability and Executive order on transparency.
Client expense: $980,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · first_quarter · Health Issues
H.R. 965, S. 340 - Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019: Issues regarding processes by which generic manufacturers can obtain sufficient quantities of brand drug samples for testing. H.R. 3253 - Empowering Beneficiaries, Ensuring Access, and Strengthening Accountability Act of 2019: Regarding all provisions. S. 1895 - The Lower Health Care Costs Act: Issues related to rural health access; health equity; Medicare Advantage; Medicaid Rebates; Medicaid Expansion; Rate Notice and Call Letter; Medicare Part D; NBPP, Part D Donut Hole; Privacy; Universal Coverage. H.R. 861 - End Surprise Billing Act, H.R. 3630 - No Surprises Act, H.R. 3502 - Protecting People from Surprise Medical Bills Act, H.R. 5800 - Ban Surprise Billing Act, H.R. 5826 - Consumer Protections Against Surprise Medical Bills Act of 2020: Issues related to surprise billing, including benchmark payments, arbitration models, and out of network billing. S. 916 - MOMMAs Act, H.R. 2602, S. 1343 - MOMMIES Act, H.R. 4996 - Helping Medicaid Offer Maternity Services Act of 2019: Issues related to options for states to extend coverage for pregnant women eligible for Medicaid via the pregnancy pathway to 365 days, Minority Maternity Care, Social Determinants of Health. S. 657 - Drug Price Transparency (DPT) Act, S. 2543 - Prescription Drug Pricing Reduction Act of 2019: Issues related to drug and price transparency. H.R. 3- Lower Drug Costs Now Act of 2019, S. 102 - Prescription Drug Pricing Reduction Act of 2019: Issues related to drug costs and prescription rebates. H.R. 6201 Families First Coronavirus Response Act, S. 3548, H.R. 748 - CARES Act: Issues regarding taxes on high cost employer-sponsored health coverage. H.R. 19 - Lower Costs, More Cures Act of 2019: Issues related to prescription drug pricing S. 2546, H.R.2279 - Safe Step Act: Issues related to managed care, prior authorization. S. 3374 - Protecting Jessica Grubb's Legacy Act: Issues regarding HIPPA, confidentiality of substance abuse records Issues related to drug and price transparency, including the Administrations rule on interoperability and Executive order on transparency.
Client expense: $1,000,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · third_quarter · Health Issues
Issues surrounding the enactment or repeal of the Affordable Care Act. Medicare reimbursement reform for providers including the Medicare Access and CHIP Reauthorization Act (MACRA). Medicare Part B Drug Reimbursement. FDA issues. Implementation of The Breast Cancer Patient Education Act. The Palliative Care and Hospice Education and Training Act. Draft legislation to reform the FDA's regulation of cosmetics. Legislation to address physician workforce shortage (HR 1763/S.348). Ensuring Lasting Smiles Act (HR 1379/S. 560). Legislation to address out of network medical bills: HR 3630, HR 3502, HR 861, S.1895, S. 1531. Improving Seniors Access to Timely Care Act, HR 3107, Safe Step Act, HR 2279. Removing Barriers to Colorectal Cancer Screening Act of 2019, HR 1570. Financial relief and policy and regulatory changes for the provider community in COVID-19 legislation including the CARES Act.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE