Closing Loopholes for Orphan Drugs Act

Issues relating to the 340B drug pricing program. H.R. 4538 - Closing Loopholes for Orphan Drugs Act S. 4160, H.R. 7838 H.R. 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act H.R. 133 - Consolidated Appropriations Act, 2021

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The 340B Drug Pricing Program; FY 2021 L-HHS Appropriations; H.R. 133: Consolidated Appropriations Act, 2021; H.R. 4538, Closing Loopholes for Orphan Drug Act; 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; H.R. 7838, To provide for certain temporary waivers with respect to the 340B drug discount program due to the COVID-19 public health emergency, and for other purposes; S.4796, Fair Care Act of 2020; H.R.8527, Fair Care Act of 2020

Client expense: $259,229 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), SENATE

Support HR 1763/ S 348, Resident Physician Shortage Reduction Act of 2019, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions; Oppose HR 506,Hospital Competition Act of 2019, a bill to amend title XVIII of the Social Security Act to increase hospital competition; Statement submitted to the House Judiciary on the hearing "Diagnosing the Problem: Exploring the Effects of Consolidation and Anticompetitive Conduct in Health Care Markets";Letter of support for the Senate Workgroups efforts to ensure consumer protections by addressing surprise medical bills and comments on the development of legislation to protect patients from surprise medical bills; Letter urging Congress and the Administration to take further action to help reduce input and administrative costs, as well as maximize the number of insured patients; Support HR 965/ S340, Creating and Restoring Equal Access to Equivalent Samples Act of 2019 or the CREATES Act of 2019, a bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products; Support HR 986/ S466 Protecting Americans with Preexisting Conditions Act of 2019, a bill provide that certain guidance related to waivers for State innovation under the Patient Protection and Affordable Care Act shall have no force or effect; Support HR 987 Strengthening Health Care and Lowering Prescription Drug Costs Act, a bill to amend the Patient Protection and Affordable Care Act to provide for Federal Exchange outreach and educational activities; Support HR 938 Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 or the BLOCKING Act of 2019, a bill to amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes; Support HR 1010, a bill to provide that the rule entitled Short-Term, Limited Duration Insurance shall have no force or effect; Support HR 1499 Protecting Consumer Access to Generic Drugs Act of 2019, a bill to prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes; Support HR 1425 State Health Care Premium Reduction Act, a bill to amend the Patient Protection and Affordable Care Act to provide for a Improve Health Insurance Affordability Fund to provide for certain reinsurance payments to lower premiums in the individual health insurance market; Support HR 1386/ S 1905 Expand Navigators Resources for Outreach, Learning, and Longevity Act of 2019 or the ENROLL Act of 2019,a bill to amend the Patient Protection and Affordable Care Act to provide for additional requirements with respect to the navigator program, and for other purposes; Support HR 1520 Purple Book Continuity Act of 2019, a bill to amend the Public Health Service Act to provide for the publication of a list of licensed biological products, and for other purposes; Support HR 1503 Orange Book Transparency Act of 2019A bill that would increase transparency for the patent status of both approved biological products and approved drugs; Support HR 2439/ HR 3414 Opioid Workforce Act of 2019, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions to help combat the opioid crisis; Submitted statement to the House Committee on Ways and Means Overcoming Racial Disparities and Social Determinants in the Maternal Mortality Crisis sharing information regarding hospitals and health systems efforts to address maternal morbidity and mortality, as we seek ways to improve outcomes and reduce health inequities for expectant and new mothers, and give their children the best possible start in life; Submitted oral and written testimony to the House Committee on Ways and Means Subcommittee on Health Hearing on Protecting Patients from Surprise Medical Bills. Protecting patients from surprise medical bills is a top priority and we have adopted a set of guiding principles to use as we evaluate legislative proposals: Define surprise bills, Protect the patient financially, Ensure patient access to emergency care, Preserve the role of private negotiation, Remove the patient from health plan/provider negotiations, Educate patients about their health care coverage, Ensure patients have access to comprehensive provider networks and accurate network information, and Support state laws that work; Letters submitted to the Energy & Commerce Committee in response to the request for comments on their surprise billing discussion draft. Concerned with the Committees draft legislations approach to determining reimbursement for out-of-network providers. Once the patient is protected from surprise bills, providers and insurers should then be permitted to negotiate payment rates for services provided. We strongly oppose approaches that would impose arbitrary rates on providers. We look forward to continuing to work with the Committee on solutions to stop surprise medical bills; Letter sent to the HELP Committee in response to the Lower Health Care Costs Act of 2019 discussion draft about our concerns about several of the proposals that would allow the government to intrude into private commercial contracts between providers and insurers. For example, several of the provisions could undermine value-based purchasing arrangements aimed directly at improving the quality of care while reducing costs. We strongly urge the Committee to remove these provisions; Submitted oral and written testimony to the House Committee on Energy and Commerce, Subcommittee on Health Hearing on No More Surprises: Protecting Patients from Surprise Medical Bills asking that the Committee preserve the ability of providers and insurers to negotiate private contracts and not establish a fixed payment amount for out-of-network services; Oppose HR 1309 Workplace Violence Prevention for Health Care and Social Service Workers Act, a bill to direct the Secretary of Labor to issue an occupational safety and health standard that requires covered employers within the health care and social service industries to develop and implement a comprehensive workplace violence prevention plan, and for other purposes; Concerns about S.1531, Stopping The Outrageous Practice of Surprise Medical Bills Act of 2019 or the STOP Surprise Medical Bills Act of 2019, to amend the Public Health Service Act to provide protections for health insurance consumers from surprise billing; Concerns about S. 1895 Lower Health Care Costs Act Letter addressed concerns about the legislative provision that sets a benchmark rate in statute for the out-of-network payments, as well as provisions that seek to change privately negotiated contracting arrangements between hospitals and insurance companies; Support HR 3425, Advancing Medical Resident Training in Community Hospitals Act of 2019, to amend title XVIII of the Social Security Act to establish rules for payment for graduate medical education (GME) costs for hospitals that establish a new medical residency training program after hosting resident rotators for short durations; Expressed concerns regarding the provisions that reduce reimbursements to providers and hospitals that administer drugs the Prescription Drug Pricing Reduction Act (PDPRA) of 2019: including about Section 107, Medicare Part B Rebate by Manufacturers for Drugs or Biologicals with Prices Increasing Faster than Inflation, Section 110, Establishment of Maximum Add-on Payment for Drugs, Biologicals, and Biosimilars, this provision would establish $1,000 as the maximum add-on amount that a provider can be paid for a separately payable drug, biological or biosimilar, Section 111, Treatment of Drug Administration Services Furnished by an Off-Campus Outpatient Department of a Provider, the site neutral payment reduction would cut aggregate hospital payments; Support S. 2091, Backlog Elimination, Legal Immigration, and Employment Visa Enhancement Act, this legislation would increase the total number of employment-based visas from 140,000 to 270,000 and ensure that critical health care workers needed in the U.S. have access to employment-based visas by carving out health care workers in designated shortage occupations from the limit; Support S 350, The Competitive Health Insurance Reform Act of 2019, a bill to restore the application of the Federal antitrust laws to the business of health insurance to protect competition and consumers; Submitted statement to Subcommittee on Health of the Committee on Energy and Commerce for the hearing on Improving Maternal Health: Legislation to Advance Prevention Efforts and Access to Care; Concerns with S. 386 and HR 1044, Fairness for High-Skilled Immigrants Act of 2019, this bill increases the per-country cap on family-based immigrant visas from 7% of the total number of such visas available that year to 15%, and eliminates the 7% cap for employment-based immigrant visas. It also removes an offset that reduced the number of visas for individuals from China; Support H.R. 4538, Closing Loopholes for Orphan Drugs Act, a bill to amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title; Discussions of provisions we support and those we recommend be changes in a draft bill called the Mitigating Existing Drug Shortages (MEDS) Act; Discussions in support of the allowing states to designate hospitals as necessary providers for purposes of waiving the critical access hospital mileage requirements; Provided comments to W&M on legislation to expand Health Profession Opportunity Grants; Support S. 2723, The Mitigating Emergency Drug Shortages (MEDS) Act, a bill to amend Sec. 506C of the Federal Food, Drug, and Cosmetic Act which strengthens requirements for drug manufacturers to disclose the root causes and expected duration of shortages, extends reporting requirements to active pharmaceutical ingredients manufacturers, requires manufacturers have contingency plans to ensure ongoing supply, develops recommendations to incentivize manufacturers to enter the market for drugs in shortage and examines the national security risks of shortages; Discuss DEA reductions in annual quotas for opioid products used by hospitals for sedation and pain management; Meeting with the Office of the Assistant Secretary of Preparedness and Response (ASPR) to discuss developments in the hospital preparedness program, the pilot projects for the Regional Disaster Healthcare System and other issues; Rural access to health care, including identifying core services needed in rural communities, outlining approaches and considerations for delivering those services, and examining access and quality in the rural context; ONCs proposed rule to implement the 21st Century Cures provision on information blocking; Supported members serving on the HHS Quality Summit panel, which was convened by the Deputy Secretary to gather input regarding how to improve and energize quality and safety improvement activities across health care system; Discussion with HHS on drug pricing, 340b, and price transparency policies, as well as the International Pricing Index ANPRM; Discussion with HHS about the work of Aligning for Health to address social determinants of health; Support S 2902, Strengthening Our Rural Health Workforce Act of 2019, a bill to enhance the rural health workforce; Meetings and correspondence with staff members of Senate Financing Committee on a proposal to support rural health care access (REH, re-opening necessary provider CAH, infrastructure funding); Letter to Ways & Means committee Rural and Underserved Communities Health Task Force in response to RFI on factors that contribute to health outcomes in these areas, examples of successful models and lessons from the field that address access and outcomes, and considerations for the unique circumstances of rural and underserved communities; Letter to Energy and Commerce Members regarding health information technology priorities; Letter of Support to Senate Appropriations on funding for the Centers for Disease Control and Prevention and the National Institutes of Health to study gun violence; Support S.2741 and H.R. 4932,Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019, a bill to amend title XVIII of the Social Security Act to expand access to telehealth services, and for other purposes; Support S 2603, Resolving Extended Limbo for Immigrant Employees and Families (RELIEF) Act, a bill to amend the Immigration and Nationality Act to end the immigrant visa backlog, and for other purposes; Support HR 4995, Maternal Health Quality Improvement Act of 2019, a bill to amend the Public Health Service Act to improve obstetric care and maternal health outcomes, and for other purposes; Concerns with HR 5800,Ban Surprise Billing Act, a bill to address surprise medical bills that relies on a median in-network rate to resolve out-of-network payments and allows for an independent dispute resolution process to determine the final payment. Concerned with the Committee's legislative approach to determining reimbursement for out-of-network providers. Oppose approaches that would impose arbitrary rates on providers, which could have significant consequences far beyond the scope of surprise medical bills. It is the insurers' responsibility to maintain comprehensive provider networks, and a default payment rate would remove incentives for health plans to contract with providers or to offer fair terms; Support HR 5826, Consumer Protections Against Surprise Medical Bills Act, a bill that prohibits providers from balance billing patients for emergency services or medical care the patient reasonably could have expected to be in-network, and from charging patients more than the in-network cost-sharing amount. Rather than rely on a benchmark payment rate to determine out-of-network reimbursement, the legislation provides a period for health plans and providers to negotiate out-of-network reimbursement, followed by a mediated dispute resolution process if necessary; Letter urging HHS to take regulatory actions to help hospitals and health systems prepare and respond to COVID-19; Letter requesting $100 billion to prepare and respond to COVID-19; Letter urging the Department of Labor to accurately define health care provider when promulgating regulations implementing key sections of the Families First Coronavirus Response Act; Letter sent to the President asking for the use of the Defense Production Act to increase the production of medical supplies and equipment; Letter to HHS regarding $100 billion emergency fund, asking HHS and CMS to directly and expediently distribute to rural and urban hospitals and health systems funds from the Public Health and Social Services Emergency Fund that were designated for providers in the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The CARES Act increased funding by $100 billion in order to reimburse eligible health care providers for health care-related expenses or lost revenues that are attributable to COVID-19. In the letter, we urged HHS and CMS to immediately distribute funding to all hospital types in the US - with additional funding going to COVID-19 hotspots; Letter urging Congress to modernize the Stafford Act as part of its next COVID-19 legislative package to allow all hospitals to recoup financial losses from this pandemic and future disasters; Letter to the Federal Reserve System, the Federal Deposit Insurance Corporation and the Office of the Comptroller of the Currency requesting they, as primary federal regulators for insured depository institutions, take prompt action to assist health care providers on the front line of the COVID-19 pandemic should the need to do so arise; Letter to the Secretary of the Treasury and the Federal Reserve Chair of the Board of Governors urging a supplement to the New Main Street Loan Facility term sheet with prompt guidance to ensure that access to this critically-necessary loan facility will be attainable for hospitals without delay; Letter was sent to the SBA urging it to ensure that small- and mid-size public hospitals, including those that have both nonprofit and public designations, are allowed to apply for and receive loans under the newly-authorized SBA Paycheck Protection Program; Letter in response to FEMAs request for input on establishing a voluntary agreement, under the Defense Production Act, of key private sector stakeholders relevant to responding to COVID-19, urging that such an agreement account for the full breadth of COVID-19 medical supply and equipment needs; Support H.R. 6474/S.3838 Healthcare Broadband Expansion During COVID-19 Act, a bill that would provide an additional $2 billion in funding for the FCC Rural Health Care program and increase the subsidy for health care providers from 65 to 85 percent. This legislation also simplifies the program to allow for more efficient application processes and disbursement of much needed funding; Support HR 6654 Emergency COVID-19 Telehealth Response Act, a bill that would codify an expanded list of providers to deliver and bill for telehealth services during the PHE; Support HR 7233Knowing the Efficiency and Efficacy of Permanent (KEEP) Telehealth Options Act of 2020, a bill that would require the Department of Health and Human Services and the Government Accountability Office (GAO) to conduct studies to provide information about the expanded use of telehealth during the COVID-19 pandemic; Letter to Senate HELP Committee in response to request for feedback on preparing for next pandemic; Discussion about telehealth waivers and flexibilities with HHS; Discussion about CARES provider relief fund distributions with HHS; Oppose HR 6559/ S 3677 COVID-19 Every Worker Protection Act of 2020, a bill to require the Occupational Safety and Health Administration to promulgate an emergency temporary standard to protect employees from occupational exposure to SARS-CoV-2, and for other purposes; Joint letter with ANA urging Congress to act quickly to get needed resources into the health care system, so that hospitals, nurses and physicians responding to COVID-19 are able to continue to provide treatments, front-line health care personnel are able to provide care and patients are able access health care services; Statement to Committee on Ways and Means for the hearing on The Disproportionate Impact of COVID-19 on Communities of Color urging Congress to employ the resources of the National Institute on Minority Health and Health Disparities - which is congressionally-mandated to coordinate the research of the other National Institutes of Healths centers and institutes related to minority health - to research and develop approaches to specifically address the COVID-19 needs of minority populations; Advocate with Congress for full forgiveness of COVID-19 related accelerated payments received by hospitals; Support S 3781Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act, a bill to increase reporting of, help mitigate potential shortages related to, and promote, accountability and transparency for pharmaceuticals and medical devices; Support S 3780 Help Onshore Manufacturing Efficiencies (HOME) for Drugs and Devices Act, a bill to encourage domestic advanced manufacturing of critical drugs and devices in order to address economic, health, and security concerns, combat shortages of critical drugs and devices, and promote increased domestic diversification of, and independence from foreign reliance on, pharmaceutical and medical device supply chains; Support S.3763 Pandemic Responder Service Award Act, a bill to establish the Pandemic Responder Service Award program to express our gratitude to front-line health care workers; Support HR 6788/ S 3599 Healthcare Workforce Resilience Act, a bill to enhance our Nations nurse and physician workforce during the COVID-19 crisis by recapturing unused immigrant visas; Urged support for joint House and Senate letter to the Administration asking for flexibility for hospitals with respect to J-1 and H-1B visa programs; Letter to Senate Finance Committee to address the important issue of maternal health and the opportunity to provide suggestions regarding how to improve maternal health in this country; Support the Temporary Reciprocity to Ensure Access to Treatment Act, a bill that allows for the temporary reciprocity for treatment by medical professionals licensed in one state to patients in other states; Letter urging the Senate to include in the next COVID-19 relief bill provisions to strengthen the federal response for racial and ethnic minority and marginalized communities, which are disproportionately affected by the pandemic;Letter asking Congress to allocate as part of the next COVID-19 relief package at least an additional $100 billion to the emergency relief fund to provide direct funding to front line health care personnel and providers to continue to respond to this pandemic; Letter sent to HHS urging them to direct HRSA to take action to stop three drug manufacturers from limiting the distribution of 340B drugs to 340B covered entities. These drug manufacturers have taken separate actions to either limit the distribution of 340B drugs or require 340B covered entities provide claims level data for investigatory purposes if that 340B covered entity uses a contract pharmacy arrangement; Letter to the Congressional Leadership asking them to not to include in the next COVID-19 relief package any surprise medical billing legislation - such as a reimbursement rate set in statute - that would further destabilize hospitals finances during the pandemic; Support S 4507, Getting Early Treatment and Comprehensive Assessments Reduces Emergencies Act of 2020 or the GET CARE Act of 2020, a bill to amend the Public Health Service Act to provide for a national campaign to raise awareness of the importance of seeking preventive health services and the utilization of such services; Comment letter addressing concerns on the proposed rule from the Departments of the Treasury, Labor and Health and Human Services that would allow certain grandfathered health plans to increase patient cost-sharing beyond current limits, without losing their grandfathered status; Letter urging the Administration to work with the AHA and Congress to create a future for telehealth that allows not only clinicians, but also hospitals and health systems, to code and bill for virtual services. We further urge CMS and HHS to continue to provide hospitals with the flexibility for annual beneficiary consent to telehealth treatment to be obtained at the same time, and not necessarily before, services are furnished; Support HR 8061,Community Immunity During COVID-19 Act of 2020, a bill that would provide funding to state and local health departments to work with community providers and organizations to increase immunization rates for Advisory Committee on Immunization Practices (ACIP)-recommended vaccines during the COVID-19 public health emergency; Letter again expressing concern with recent actions taken by several major drug manufacturers to limit the distribution of certain 340B drugs to our hospital members. While we understand that the HRSA is further investigating these actions, we urge swift and decisive action to halt these pernicious tactics so as to prevent other manufacturers from following suit; Comment letter outlining our concerns about the ability of hospital systems to distribute provider relief funds among the parent and subsidiaries. HHS published certain FAQs that place problematic restrictions on the use of CARES Act provider relief fund dollars. Specifically, the FAQs restrict the ability of a hospital system to allocate the funds throughout its system where COVID-19 related expenses and lost revenues are occurring; Submitted comments in response to HRSAs RFI on Health Professional Shortage Area (HPSA) scoring. HPSA scores are important for rural hospitals and clinics ability to recruit physicians and other clinicians, namely from the National Health Service Corps (NHSC) program. Letter asking HHS to reinstate the COVID-19 Provider Relief Fund reporting requirements.

The 340B Drug Pricing Program; FY 2021 L-HHS Appropriations; H.R. 4538, Closing Loopholes for Orphan Drug Act; S. 3631, Relief for Rural Providers During Emergencies Act; 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; S. 4199, A bill to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes; H.R. 7838, To provide for certain temporary waivers with respect to the 340B drug discount program due to the COVID-19 public health emergency, and for other purposes.

Client expense: $267,118 · Firm income: Not reported

General issues relating to Medicare, Medicaid, disproportionate share hospital payment, 340B, and COVID-19 relief. H.R. 4538 - Closing Loopholes for Orphan Drugs Act S. 4160, H.R. 7838 H.R. 6800 - The Heroes Act H.R. 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act H.R. 925 - The HEROES Act

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General issues relating to Medicare, Medicaid, disproportionate share hospital payment, 340B, and COVID-19 relief. H.R. 4538 - Closing Loopholes for Orphan Drugs Act S. 4160, H.R. 7838 H.R. 6800 - The Heroes Act H.R. 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act H.R. 925 - The HEROES Act

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to the 340B drug pricing program. H.R. 4538 - Closing Loopholes for Orphan Drugs Act S. 4160, H.R. 7838 H.R. 6800 - The Heroes Act H.R. 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act H.R. 925 - The HEROES Act

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to the 340B drug pricing program. H.R. 4538 - Closing Loopholes for Orphan Drugs Act S. 4160, H.R. 7838 H.R. 6800 - The Heroes Act H.R. 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act H.R. 925 - The HEROES Act

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support HR 1763/ S 348, Resident Physician Shortage Reduction Act of 2019, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions; Oppose HR 506,Hospital Competition Act of 2019, a bill to amend title XVIII of the Social Security Act to increase hospital competition; Statement submitted to the House Judiciary on the hearing "Diagnosing the Problem: Exploring the Effects of Consolidation and Anticompetitive Conduct in Health Care Markets";Letter of support for the Senate Workgroups efforts to ensure consumer protections by addressing surprise medical bills and comments on the development of legislation to protect patients from surprise medical bills; Letter urging Congress and the Administration to take further action to help reduce input and administrative costs, as well as maximize the number of insured patients; Support HR 965/ S340, Creating and Restoring Equal Access to Equivalent Samples Act of 2019 or the CREATES Act of 2019, a bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products; Support HR 986/ S466 Protecting Americans with Preexisting Conditions Act of 2019, a bill provide that certain guidance related to waivers for State innovation under the Patient Protection and Affordable Care Act shall have no force or effect; Support HR 987 Strengthening Health Care and Lowering Prescription Drug Costs Act, a bill to amend the Patient Protection and Affordable Care Act to provide for Federal Exchange outreach and educational activities; Support HR 938 Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 or the BLOCKING Act of 2019, a bill to amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes; Support HR 1010, a bill to provide that the rule entitled Short-Term, Limited Duration Insurance shall have no force or effect; Support HR 1499 Protecting Consumer Access to Generic Drugs Act of 2019, a bill to prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes; Support HR 1425 State Health Care Premium Reduction Act, a bill to amend the Patient Protection and Affordable Care Act to provide for a Improve Health Insurance Affordability Fund to provide for certain reinsurance payments to lower premiums in the individual health insurance market; Support HR 1386/ S 1905 Expand Navigators Resources for Outreach, Learning, and Longevity Act of 2019 or the ENROLL Act of 2019,a bill to amend the Patient Protection and Affordable Care Act to provide for additional requirements with respect to the navigator program, and for other purposes; Support HR 1520 Purple Book Continuity Act of 2019, a bill to amend the Public Health Service Act to provide for the publication of a list of licensed biological products, and for other purposes; Support HR 1503 Orange Book Transparency Act of 2019A bill that would increase transparency for the patent status of both approved biological products and approved drugs; Support HR 2439/ HR 3414 Opioid Workforce Act of 2019, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions to help combat the opioid crisis; Submitted statement to the House Committee on Ways and Means Overcoming Racial Disparities and Social Determinants in the Maternal Mortality Crisis sharing information regarding hospitals and health systems efforts to address maternal morbidity and mortality, as we seek ways to improve outcomes and reduce health inequities for expectant and new mothers, and give their children the best possible start in life; Submitted oral and written testimony to the House Committee on Ways and Means Subcommittee on Health Hearing on Protecting Patients from Surprise Medical Bills. Protecting patients from surprise medical bills is a top priority and we have adopted a set of guiding principles to use as we evaluate legislative proposals: Define surprise bills, Protect the patient financially, Ensure patient access to emergency care, Preserve the role of private negotiation, Remove the patient from health plan/provider negotiations, Educate patients about their health care coverage, Ensure patients have access to comprehensive provider networks and accurate network information, and Support state laws that work; Letters submitted to the Energy & Commerce Committee in response to the request for comments on their surprise billing discussion draft. Concerned with the Committees draft legislations approach to determining reimbursement for out-of-network providers. Once the patient is protected from surprise bills, providers and insurers should then be permitted to negotiate payment rates for services provided. We strongly oppose approaches that would impose arbitrary rates on providers. We look forward to continuing to work with the Committee on solutions to stop surprise medical bills; Letter sent to the HELP Committee in response to the Lower Health Care Costs Act of 2019 discussion draft about our concerns about several of the proposals that would allow the government to intrude into private commercial contracts between providers and insurers. For example, several of the provisions could undermine value-based purchasing arrangements aimed directly at improving the quality of care while reducing costs. We strongly urge the Committee to remove these provisions; Submitted oral and written testimony to the House Committee on Energy and Commerce, Subcommittee on Health Hearing on No More Surprises: Protecting Patients from Surprise Medical Bills asking that the Committee preserve the ability of providers and insurers to negotiate private contracts and not establish a fixed payment amount for out-of-network services; Oppose HR 1309 Workplace Violence Prevention for Health Care and Social Service Workers Act, a bill to direct the Secretary of Labor to issue an occupational safety and health standard that requires covered employers within the health care and social service industries to develop and implement a comprehensive workplace violence prevention plan, and for other purposes; Concerns about S.1531, Stopping The Outrageous Practice of Surprise Medical Bills Act of 2019 or the STOP Surprise Medical Bills Act of 2019, to amend the Public Health Service Act to provide protections for health insurance consumers from surprise billing; Concerns about S. 1895 Lower Health Care Costs Act Letter addressed concerns about the legislative provision that sets a benchmark rate in statute for the out-of-network payments, as well as provisions that seek to change privately negotiated contracting arrangements between hospitals and insurance companies; Support HR 3425, Advancing Medical Resident Training in Community Hospitals Act of 2019, to amend title XVIII of the Social Security Act to establish rules for payment for graduate medical education (GME) costs for hospitals that establish a new medical residency training program after hosting resident rotators for short durations; Expressed concerns regarding the provisions that reduce reimbursements to providers and hospitals that administer drugs the Prescription Drug Pricing Reduction Act (PDPRA) of 2019: including about Section 107, Medicare Part B Rebate by Manufacturers for Drugs or Biologicals with Prices Increasing Faster than Inflation, Section 110, Establishment of Maximum Add-on Payment for Drugs, Biologicals, and Biosimilars, this provision would establish $1,000 as the maximum add-on amount that a provider can be paid for a separately payable drug, biological or biosimilar, Section 111, Treatment of Drug Administration Services Furnished by an Off-Campus Outpatient Department of a Provider, the site neutral payment reduction would cut aggregate hospital payments; Support S. 2091, Backlog Elimination, Legal Immigration, and Employment Visa Enhancement Act, this legislation would increase the total number of employment-based visas from 140,000 to 270,000 and ensure that critical health care workers needed in the U.S. have access to employment-based visas by carving out health care workers in designated shortage occupations from the limit; Support S 350, The Competitive Health Insurance Reform Act of 2019, a bill to restore the application of the Federal antitrust laws to the business of health insurance to protect competition and consumers; Submitted statement to Subcommittee on Health of the Committee on Energy and Commerce for the hearing on Improving Maternal Health: Legislation to Advance Prevention Efforts and Access to Care; Concerns with S. 386 and HR 1044, Fairness for High-Skilled Immigrants Act of 2019, this bill increases the per-country cap on family-based immigrant visas from 7% of the total number of such visas available that year to 15%, and eliminates the 7% cap for employment-based immigrant visas. It also removes an offset that reduced the number of visas for individuals from China; Support H.R. 4538, Closing Loopholes for Orphan Drugs Act, a bill to amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title; Discussions of provisions we support and those we recommend be changes in a draft bill called the Mitigating Existing Drug Shortages (MEDS) Act; Discussions in support of the allowing states to designate hospitals as necessary providers for purposes of waiving the critical access hospital mileage requirements; Provided comments to W&M on legislation to expand Health Profession Opportunity Grants; Support S. 2723, The Mitigating Emergency Drug Shortages (MEDS) Act, a bill to amend Sec. 506C of the Federal Food, Drug, and Cosmetic Act which strengthens requirements for drug manufacturers to disclose the root causes and expected duration of shortages, extends reporting requirements to active pharmaceutical ingredients manufacturers, requires manufacturers have contingency plans to ensure ongoing supply, develops recommendations to incentivize manufacturers to enter the market for drugs in shortage and examines the national security risks of shortages; Discuss DEA reductions in annual quotas for opioid products used by hospitals for sedation and pain management; Meeting with the Office of the Assistant Secretary of Preparedness and Response (ASPR) to discuss developments in the hospital preparedness program, the pilot projects for the Regional Disaster Healthcare System and other issues; Rural access to health care, including identifying core services needed in rural communities, outlining approaches and considerations for delivering those services, and examining access and quality in the rural context; ONCs proposed rule to implement the 21st Century Cures provision on information blocking; Supported members serving on the HHS Quality Summit panel, which was convened by the Deputy Secretary to gather input regarding how to improve and energize quality and safety improvement activities across health care system; Discussion with HHS on drug pricing, 340b, and price transparency policies, as well as the International Pricing Index ANPRM; Discussion with HHS about the work of Aligning for Health to address social determinants of health; Support S 2902, Strengthening Our Rural Health Workforce Act of 2019, a bill to enhance the rural health workforce; Meetings and correspondence with staff members of Senate Financing Committee on a proposal to support rural health care access (REH, re-opening necessary provider CAH, infrastructure funding); Letter to Ways & Means committee Rural and Underserved Communities Health Task Force in response to RFI on factors that contribute to health outcomes in these areas, examples of successful models and lessons from the field that address access and outcomes, and considerations for the unique circumstances of rural and underserved communities; Letter to Energy and Commerce Members regarding health information technology priorities; Letter of Support to Senate Appropriations on funding for the Centers for Disease Control and Prevention and the National Institutes of Health to study gun violence; Support S.2741 and H.R. 4932,Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019, a bill to amend title XVIII of the Social Security Act to expand access to telehealth services, and for other purposes; Support S 2603, Resolving Extended Limbo for Immigrant Employees and Families (RELIEF) Act, a bill to amend the Immigration and Nationality Act to end the immigrant visa backlog, and for other purposes; Support HR 4995, Maternal Health Quality Improvement Act of 2019, a bill to amend the Public Health Service Act to improve obstetric care and maternal health outcomes, and for other purposes; Concerns with HR 5800,Ban Surprise Billing Act, a bill to address surprise medical bills that relies on a median in-network rate to resolve out-of-network payments and allows for an independent dispute resolution process to determine the final payment. Concerned with the Committee's legislative approach to determining reimbursement for out-of-network providers. Oppose approaches that would impose arbitrary rates on providers, which could have significant consequences far beyond the scope of surprise medical bills. It is the insurers' responsibility to maintain comprehensive provider networks, and a default payment rate would remove incentives for health plans to contract with providers or to offer fair terms; Support HR 5826, Consumer Protections Against Surprise Medical Bills Act, a bill that prohibits providers from balance billing patients for emergency services or medical care the patient reasonably could have expected to be in-network, and from charging patients more than the in-network cost-sharing amount. Rather than rely on a benchmark payment rate to determine out-of-network reimbursement, the legislation provides a period for health plans and providers to negotiate out-of-network reimbursement, followed by a mediated dispute resolution process if necessary; Letter urging HHS to take regulatory actions to help hospitals and health systems prepare and respond to COVID-19; Letter requesting $100 billion to prepare and respond to COVID-19; Letter urging the Department of Labor to accurately define health care provider when promulgating regulations implementing key sections of the Families First Coronavirus Response Act; Letter sent to the President asking for the use of the Defense Production Act to increase the production of medical supplies and equipment; Letter to HHS regarding $100 billion emergency fund, asking HHS and CMS to directly and expediently distribute to rural and urban hospitals and health systems funds from the Public Health and Social Services Emergency Fund that were designated for providers in the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The CARES Act increased funding by $100 billion in order to reimburse eligible health care providers for health care-related expenses or lost revenues that are attributable to COVID-19. In the letter, we urged HHS and CMS to immediately distribute funding to all hospital types in the US - with additional funding going to COVID-19 hotspots; Letter urging Congress to modernize the Stafford Act as part of its next COVID-19 legislative package to allow all hospitals to recoup financial losses from this pandemic and future disasters; Letter to the Federal Reserve System, the Federal Deposit Insurance Corporation and the Office of the Comptroller of the Currency requesting they, as primary federal regulators for insured depository institutions, take prompt action to assist health care providers on the front line of the COVID-19 pandemic should the need to do so arise; Letter to the Secretary of the Treasury and the Federal Reserve Chair of the Board of Governors urging a supplement to the New Main Street Loan Facility term sheet with prompt guidance to ensure that access to this critically-necessary loan facility will be attainable for hospitals without delay; Letter was sent to the SBA urging it to ensure that small- and mid-size public hospitals, including those that have both nonprofit and public designations, are allowed to apply for and receive loans under the newly-authorized SBA Paycheck Protection Program; Letter in response to FEMAs request for input on establishing a voluntary agreement, under the Defense Production Act, of key private sector stakeholders relevant to responding to COVID-19, urging that such an agreement account for the full breadth of COVID-19 medical supply and equipment needs; Support H.R. 6474/S.3838 Healthcare Broadband Expansion During COVID-19 Act, a bill that would provide an additional $2 billion in funding for the FCC Rural Health Care program and increase the subsidy for health care providers from 65 to 85 percent. This legislation also simplifies the program to allow for more efficient application processes and disbursement of much needed funding; Support HR 6654 Emergency COVID-19 Telehealth Response Act, a bill that would codify an expanded list of providers to deliver and bill for telehealth services during the PHE; Support HR 7233Knowing the Efficiency and Efficacy of Permanent (KEEP) Telehealth Options Act of 2020, a bill that would require the Department of Health and Human Services and the Government Accountability Office (GAO) to conduct studies to provide information about the expanded use of telehealth during the COVID-19 pandemic; Letter to Senate HELP Committee in response to request for feedback on preparing for next pandemic; Discussion about telehealth waivers and flexibilities with HHS; Discussion about CARES provider relief fund distributions with HHS; Oppose HR 6559/ S 3677 COVID-19 Every Worker Protection Act of 2020, a bill to require the Occupational Safety and Health Administration to promulgate an emergency temporary standard to protect employees from occupational exposure to SARS-CoV-2, and for other purposes; Joint letter with ANA urging Congress to act quickly to get needed resources into the health care system, so that hospitals, nurses and physicians responding to COVID-19 are able to continue to provide treatments, front-line health care personnel are able to provide care and patients are able access health care services; Statement to Committee on Ways and Means for the hearing on The Disproportionate Impact of COVID-19 on Communities of Color urging Congress to employ the resources of the National Institute on Minority Health and Health Disparities - which is congressionally-mandated to coordinate the research of the other National Institutes of Healths centers and institutes related to minority health - to research and develop approaches to specifically address the COVID-19 needs of minority populations; Advocate with Congress for full forgiveness of COVID-19 related accelerated payments received by hospitals; Support S 3781Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act, a bill to increase reporting of, help mitigate potential shortages related to, and promote, accountability and transparency for pharmaceuticals and medical devices; Support S 3780 Help Onshore Manufacturing Efficiencies (HOME) for Drugs and Devices Act, a bill to encourage domestic advanced manufacturing of critical drugs and devices in order to address economic, health, and security concerns, combat shortages of critical drugs and devices, and promote increased domestic diversification of, and independence from foreign reliance on, pharmaceutical and medical device supply chains; Support S.3763 Pandemic Responder Service Award Act, a bill to establish the Pandemic Responder Service Award program to express our gratitude to front-line health care workers; Support HR 6788/ S 3599 Healthcare Workforce Resilience Act, a bill to enhance our Nations nurse and physician workforce during the COVID-19 crisis by recapturing unused immigrant visas; Urged support for joint House and Senate letter to the Administration asking for flexibility for hospitals with respect to J-1 and H-1B visa programs; Letter to Senate Finance Committee to address the important issue of maternal health and the opportunity to provide suggestions regarding how to improve maternal health in this country; Support the Temporary Reciprocity to Ensure Access to Treatment Act, a bill that allows for the temporary reciprocity for treatment by medical professionals licensed in one state to patients in other states.

Support HR 1763/ S 348, Resident Physician Shortage Reduction Act of 2019, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions; Oppose HR 506,Hospital Competition Act of 2019, a bill to amend title XVIII of the Social Security Act to increase hospital competition; Statement submitted to the House Judiciary on the hearing "Diagnosing the Problem: Exploring the Effects of Consolidation and Anticompetitive Conduct in Health Care Markets";Letter of support for the Senate Workgroups efforts to ensure consumer protections by addressing surprise medical bills and comments on the development of legislation to protect patients from surprise medical bills; Letter urging Congress and the Administration to take further action to help reduce input and administrative costs, as well as maximize the number of insured patients; Comment letter urged CMS to extend the comment period for the proposed rules related to interoperability provisions of the 21st Century Cures Act by at least 30 days; Comment letter on the Food and Drug Administrations (FDA) draft guidance on blood glucose monitoring test systems (BGMS) for prescription point-of-care (POC) use and urge FDA to consider compiling a finite list of universally acceptable disinfectant products that would apply to all medical devices or classes of device; Comment letter that urged CMS to address the substantial flaws in the star ratings methodology since the ratings inception in 2016 and to suspend the display of overall star ratings on Hospital Compare while the agency continues its important work of enhancing the validity and meaningfulness of star ratings; Comment letter to FDA on the public meeting, Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions with the following legislative recommendations: Strengthen manufacturers drug shortage disclosure requirements, Incentivize manufacturing contingency plans and/or redundancies, Enhance production transparency requirements, Enact shortage disclosure notification requirements for certain medical devices needed to administer drugs, Assess drug shortages as a national security threat, Include potential risk for drug shortages as a factor in the Federal Trade Commission (FTC) reviews of drug company merger proposals, and regulatory recommendations: Establish incentives to encourage manufacturers to produce drugs in shortage, Prevent manufacturing shutdowns, Establish a quality manufacturing initiative, Enhance information on the quality of outsourcing facilities compounding, Expand and improve the FDAs drug shortages list, Develop a list of critical drugs, Consider how reducing the number of unapproved drugs1 on the market might impact shortages, Reduce drug waste, Create an Office of Clinical Affairs within the Drug Enforcement Administration (DEA); Comment letter urging the CMS to use its upcoming proposed rules for Inpatient Rehabilitation Facility (IRF) and other post-acute care providers to address several issues related to the implementation of the revised case-mix grouping (CMG) policies; Support HR 965/ S340, Creating and Restoring Equal Access to Equivalent Samples Act of 2019 or the CREATES Act of 2019, a bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products; Support HR 986/ S466 Protecting Americans with Preexisting Conditions Act of 2019, a bill provide that certain guidance related to waivers for State innovation under the Patient Protection and Affordable Care Act shall have no force or effect; Support HR 987 Strengthening Health Care and Lowering Prescription Drug Costs Act, a bill to amend the Patient Protection and Affordable Care Act to provide for Federal Exchange outreach and educational activities; Support HR 938 Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 or the BLOCKING Act of 2019, a bill to amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes; Support HR 1010, a bill to provide that the rule entitled Short-Term, Limited Duration Insurance shall have no force or effect; Support HR 1499 Protecting Consumer Access to Generic Drugs Act of 2019, a bill to prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes; Support HR 1425 State Health Care Premium Reduction Act, a bill to amend the Patient Protection and Affordable Care Act to provide for a Improve Health Insurance Affordability Fund to provide for certain reinsurance payments to lower premiums in the individual health insurance market; Support HR 1386/ S 1905 Expand Navigators Resources for Outreach, Learning, and Longevity Act of 2019 or the ENROLL Act of 2019,a bill to amend the Patient Protection and Affordable Care Act to provide for additional requirements with respect to the navigator program, and for other purposes; Support HR 1520 Purple Book Continuity Act of 2019, a bill to amend the Public Health Service Act to provide for the publication of a list of licensed biological products, and for other purposes; Support HR 1503 Orange Book Transparency Act of 2019A bill that would increase transparency for the patent status of both approved biological products and approved drugs; Support HR 2439/ HR 3414 Opioid Workforce Act of 2019, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions to help combat the opioid crisis; Submitted statement to the House Committee on Ways and Means Overcoming Racial Disparities and Social Determinants in the Maternal Mortality Crisis sharing information regarding hospitals and health systems efforts to address maternal morbidity and mortality, as we seek ways to improve outcomes and reduce health inequities for expectant and new mothers, and give their children the best possible start in life; Submitted oral and written testimony to the House Committee on Ways and Means Subcommittee on Health Hearing on Protecting Patients from Surprise Medical Bills. Protecting patients from surprise medical bills is a top priority and we have adopted a set of guiding principles to use as we evaluate legislative proposals: Define surprise bills, Protect the patient financially, Ensure patient access to emergency care, Preserve the role of private negotiation, Remove the patient from health plan/provider negotiations, Educate patients about their health care coverage, Ensure patients have access to comprehensive provider networks and accurate network information, and Support state laws that work; Letters submitted to the Energy & Commerce Committee in response to the request for comments on their surprise billing discussion draft. Concerned with the Committees draft legislations approach to determining reimbursement for out-of-network providers. Once the patient is protected from surprise bills, providers and insurers should then be permitted to negotiate payment rates for services provided. We strongly oppose approaches that would impose arbitrary rates on providers. We look forward to continuing to work with the Committee on solutions to stop surprise medical bills; Letter sent to the HELP Committee in response to the Lower Health Care Costs Act of 2019 discussion draft about our concerns about several of the proposals that would allow the government to intrude into private commercial contracts between providers and insurers. For example, several of the provisions could undermine value-based purchasing arrangements aimed directly at improving the quality of care while reducing costs. We strongly urge the Committee to remove these provisions; Submitted oral and written testimony to the House Committee on Energy and Commerce, Subcommittee on Health Hearing on No More Surprises: Protecting Patients from Surprise Medical Bills asking that the Committee preserve the ability of providers and insurers to negotiate private contracts and not establish a fixed payment amount for out-of-network services; Oppose HR 1309 Workplace Violence Prevention for Health Care and Social Service Workers Act, a bill to direct the Secretary of Labor to issue an occupational safety and health standard that requires covered employers within the health care and social service industries to develop and implement a comprehensive workplace violence prevention plan, and for other purposes; Concerns about S.1531, Stopping The Outrageous Practice of Surprise Medical Bills Act of 2019 or the STOP Surprise Medical Bills Act of 2019, to amend the Public Health Service Act to provide protections for health insurance consumers from surprise billing; Concerns about S. 1895 Lower Health Care Costs Act Letter addressed concerns about the legislative provision that sets a benchmark rate in statute for the out-of-network payments, as well as provisions that seek to change privately negotiated contracting arrangements between hospitals and insurance companies; Support HR 3425, Advancing Medical Resident Training in Community Hospitals Act of 2019, to amend title XVIII of the Social Security Act to establish rules for payment for graduate medical education (GME) costs for hospitals that establish a new medical residency training program after hosting resident rotators for short durations; Expressed concerns regarding the provisions that reduce reimbursements to providers and hospitals that administer drugs the Prescription Drug Pricing Reduction Act (PDPRA) of 2019: including about Section 107, Medicare Part B Rebate by Manufacturers for Drugs or Biologicals with Prices Increasing Faster than Inflation, Section 110, Establishment of Maximum Add-on Payment for Drugs, Biologicals, and Biosimilars, this provision would establish $1,000 as the maximum add-on amount that a provider can be paid for a separately payable drug, biological or biosimilar, Section 111, Treatment of Drug Administration Services Furnished by an Off-Campus Outpatient Department of a Provider, the site neutral payment reduction would cut aggregate hospital payments; Support S. 2091, Backlog Elimination, Legal Immigration, and Employment Visa Enhancement Act, this legislation would increase the total number of employment-based visas from 140,000 to 270,000 and ensure that critical health care workers needed in the U.S. have access to employment-based visas by carving out health care workers in designated shortage occupations from the limit; Support S 350, The Competitive Health Insurance Reform Act of 2019, a bill to restore the application of the Federal antitrust laws to the business of health insurance to protect competition and consumers; Support letter for the adoption of a unique patient identifier (UPI, by removing the prohibition on the use of federal funds to promulgate or adopt a national UPI would provide HHS the ability to explore solutions that link patients with their correct medical records; Submitted statement to Subcommittee on Health of the Committee on Energy and Commerce for the hearing on Improving Maternal Health: Legislation to Advance Prevention Efforts and Access to Care; Concerns with S. 386 and HR 1044, Fairness for High-Skilled Immigrants Act of 2019, this bill increases the per-country cap on family-based immigrant visas from 7% of the total number of such visas available that year to 15%, and eliminates the 7% cap for employment-based immigrant visas. It also removes an offset that reduced the number of visas for individuals from China; Support H.R. 4538, Closing Loopholes for Orphan Drugs Act, a bill to amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title; Discussions of provisions we support and those we recommend be changes in a draft bill called the Mitigating Existing Drug Shortages (MEDS) Act; Discussions in support of the allowing states to designate hospitals as necessary providers for purposes of waiving the critical access hospital mileage requirements; Provided comments to W&M on legislation to expand Health Profession Opportunity Grants; Support S. 2723, The Mitigating Emergency Drug Shortages (MEDS) Act, a bill to amend Sec. 506C of the Federal Food, Drug, and Cosmetic Act which strengthens requirements for drug manufacturers to disclose the root causes and expected duration of shortages, extends reporting requirements to active pharmaceutical ingredients manufacturers, requires manufacturers have contingency plans to ensure ongoing supply, develops recommendations to incentivize manufacturers to enter the market for drugs in shortage and examines the national security risks of shortages; DEA reductions in annual quotas for opioid products used by hospitals for sedation and pain management; Meeting with the Office of the Assistant Secretary of Preparedness and Response (ASPR) to discuss developments in the hospital preparedness program, the pilot projects for the Regional Disaster Healthcare System and other issues; Rural access to health care, including identifying core services needed in rural communities, outlining approaches and considerations for delivering those services, and examining access and quality in the rural context; ONCs proposed rule to implement the 21st Century Cures provision on information blocking; Supported members serving on the HHS Quality Summit panel, which was convened by the Deputy Secretary to gather input regarding how to improve and energize quality and safety improvement activities across health care system; Discussion with HHS on drug pricing, 340b, and price transparency policies, as well as the International Pricing Index ANPRM; Discussion with HHS about the work of Aligning for Health to address social determinants of health; Support S 2902, Strengthening Our Rural Health Workforce Act of 2019, a bill to enhance the rural health workforce; Meetings and correspondence with staff members of Senate Financing Committee on a proposal to support rural health care access (REH, re-opening necessary provider CAH, infrastructure funding); Letter to Ways & Means committee Rural and Underserved Communities Health Task Force in response to RFI on factors that contribute to health outcomes in these areas, examples of successful models and lessons from the field that address access and outcomes, and considerations for the unique circumstances of rural and underserved communities; Letter to Energy and Commerce Members regarding health information technology priorities; Letter of Support to Senate Appropriations on funding for the Centers for Disease Control and Prevention and the National Institutes of Health to study gun violence; Support S.2741 and H.R. 4932,Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019, a bill to amend title XVIII of the Social Security Act to expand access to telehealth services, and for other purposes; Support S 2603, Resolving Extended Limbo for Immigrant Employees and Families (RELIEF) Act, a bill to amend the Immigration and Nationality Act to end the immigrant visa backlog, and for other purposes; Support HR 4995, Maternal Health Quality Improvement Act of 2019, a bill to amend the Public Health Service Act to improve obstetric care and maternal health outcomes, and for other purposes. Concerns with HR 5800,Ban Surprise Billing Act, a bill to address surprise medical bills that relies on a median in-network rate to resolve out-of-network payments and allows for an independent dispute resolution process to determine the final payment. Concerned with the Committee's legislative approach to determining reimbursement for out-of-network providers. Oppose approaches that would impose arbitrary rates on providers, which could have significant consequences far beyond the scope of surprise medical bills. It is the insurers' responsibility to maintain comprehensive provider networks, and a default payment rate would remove incentives for health plans to contract with providers or to offer fair terms; Support HR 5826, Consumer Protections Against Surprise Medical Bills Act, a bill that prohibits providers from balance billing patients for emergency services or medical care the patient reasonably could have expected to be in-network, and from charging patients more than the in-network cost-sharing amount. Rather than rely on a benchmark payment rate to determine out-of-network reimbursement, the legislation provides a period for health plans and providers to negotiate out-of-network reimbursement, followed by a mediated dispute resolution process if necessary; Letter urging HHS to take regulatory actions to help hospitals and health systems prepare and respond to COVID-19; Letter requesting $100 billion to prepare and respond to COVID-19; Letter urging the Department of Labor to accurately define health care provider when promulgating regulations implementing key sections of the Families First Coronavirus Response Act; Letter sent to the President today asking for the use of the Defense Production Act to increase the production of medical supplies and equipment; Letter to HHS regarding $100 billion emergency fund, asking HHS and CMS to directly and expediently distribute to rural and urban hospitals and health systems funds from the Public Health and Social Services Emergency Fund that were designated for providers in the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The CARES Act increased funding by $100 billion in order to reimburse eligible health care providers for health care-related expenses or lost revenues that are attributable to COVID-19. In the letter, we urged HHS and CMS to immediately distribute funding to all hospital types in the US - with additional funding going to COVID-19 hotspots; Letter urging Congress to modernize the Stafford Act as part of its next COVID-19 legislative package to allow all hospitals to recoup financial losses from this pandemic and future disasters.

H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release (FAIR) of Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1922: Restoring Access to Medication Act of 2019 - Provisions related to prescription drug access H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes - Provisions related to prescription drug samples H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples H.R. 2296: FAIR Drug Pricing Act of 2019 / More Efficient Tools to Realize Information for Consumers Act - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2734: Safer Prescribing of Controlled Substances Act - Provisions related to the prescribing of prescription drugs H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 3327: Drug Price Transparency for Medicare Patients Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 3415: Real-Time Beneficiary Drug Cost Bill - Provisions related to drug pricing transparency H.R. 3947: Competition Prescription Act of 2019 - Provisions related to prescription drug pricing, patents, and other provisions H.R. 4106: Responsibility in Drug Advertising Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 4158: CURE High Drug Prices Act - Provisions related to prescription drug pricing and transparency H.R. 4244: MAGIC Act - Provisions related to FDA approval pathways H.R. 4439: Creating Hope Reauthorization Act - Provisions related to rare disease priority review vouchers H.R. 4538: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B prescription drug exclusions H.R. 4633: Investing in Safety and Innovation Act of 2019 - Provisions related to FDA programs reauthorization H.R. 4640: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2019 - Provisions related to prescription drug pricing and negotiation H.R. 4667: Biomedical Innovation Expansion Act of 2019 - Provisions related to NIH programs reauthorization H.R. 4710: Pharmaceutical Independence Long-Term Readiness Reform Act - Provisions related to the supply chain H.R. 4711: No Tax Breaks for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising H.R. 4812: Ensuring Compliance Against Drug Diversion Act of 2019 - Provisions related to registrations under the Controlled Substances Act H.R. 4866: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019 - Provisions related to designation of universities as centers of excellence supporting manufacturing H.R. 4963: Stop the Importation and Manufacturing of Synthetic Analogues Act of 2019 - Provisions related to synthetic analogues H.R. 5031: Medical Innovation Act of 2019 - Provisions related to prescription drug manufacturer taxation and supplemental fees H.R. 5198: Patients' Right to Know Their Medication Act of 2019 - Provisions related to prescription drug labeling H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 5304: PBM Transparency in Prescription Drug Costs Act - Provisions related to prescription drug pricing transparency H.R. 5381: International Pharmaceutical Transparency Act of 2019 - Provisions related to prescription drug labeling H.R. 5442: To amend title XXVII of the Public Health Service Act and title XVIII of the Social Security Act to require pharmacies to disclose any differential between the cost of a prescription drug based on whether certain individuals use prescription drug coverage to acquire such drug, and for other purposes. - Provisions related to prescription drug pricing and transparency H.R. 5497: Conditional Approval Act - Provisions related to approval pathway S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 658: Accelerated Drug Approval for Prescription Therapies Act - Provisions related to FDA drug approvals S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1250: American Cures Act - Provisions related to pharmaceutical research and development S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 2004: Emergency Access to Insulin Act of 2019 - Provisions related to prescription drug pricing S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2723: Mitigating Emergency Drug Shortages Act - Provisions related to prescription drug pricing transparency and other provisions S. 2897: Patient-Centered Outcomes Research Institute Reauthorization Act - Provisions related to PCORI reauthorization Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49) Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Monograph Reform, HSA/FSAs S 2740 - Over-the-Counter Monograph Safety S1872/HR5076, Protecting Seniors Through Immunization Act S1654/HR1973, Vaccine Access Improvement Act

S. 61, Safe and Affordable Drugs from Canada Act (Grassley) - drug importation S. 64, Preserve Access to Affordable Generics and Biosimilars Act (Grassley-Klobuchar) - prohibiting pay-for-delay settlements S. 73, End Taxpayer Subsidies for Drug Ads Act (Shaheen) - prohibiting tax deduction for DTC advertising expenses S. 102, Prescription Drug Price Relief Act (Sanders) - reforms linked to international pricing S. 340, CREATES Act (Leahy) - removing barriers to generic drugs S. 344, Hatch-Waxman Integrity Act (Tillis) - inter partes review process S. 366, FLAT Prices Act (Durbin) - reforms for drugs with sudden price spikes S. 378, Stop Price Gouging Act (Durbin) - excise tax for drugs that have price spikes S. 440, Preserving Access to Cost-Effective Drugs Act (Cotton) - sovereign immunity and Inter Partes Review process S. 474, SPIKE Act (Wyden) - justification for drug price increases S. 476, Creating Transparency to Have Drug Rebates Unlocked Act (Wyden) - drug price transparency S. 637, CURE High Drug Prices Act (Blumenthal) - remedies for price gouging S. 657, Point of Sale Rebates (Braun) S. 659, Biologic Patent Transparency Act (Collins) - patent disclosure requirements S. 660, Efficiency and Transparency in Petitions Act (Braun) - FDA citizen petition process S. 844, Short on Competition Act (Klobuchar) - remedies for marginally competitive drug markets S. 977, Transparency Drug Pricing Act (Scott) - transparency and drug pricing reforms S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act (Cassidy) - preventing evergreening of patent protections S. 1224, Stop STALLING Act (Klobuchar) - citizen petition process S. 1227, Prescription Pricing for the People Act (Grassley) - FTC report on role of PBMs and allegations of anticompetitive conduct by manufacturers of sole-source drugs S. 1384, Prescription Drug Rebate Reform Act (Romney-Braun) - prescription drug cost sharing S. 1416, Affordable Prescriptions for Patients Act (Cornyn) - product hopping, patent thickets S. 1664, Prescription Drug Price Reporting Act (Scott) - prescription drug price reporting S. 2247, Phair Relief Act of 2019 (Kennedy)-transparency around price concessions for drugs S. 2387, We Protect American Investment in Drugs Act (Van Hollen)-drug pricing S. 2543, Prescription Drug Pricing Reduction Act of 2019 (Grassley)-Drug pricing S. 2740, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 (Isakson) - regulations re nonprescription drugs that are marketed without an approved new drug application S. 3052, United States-Mexico-Canada Agreement Implementation Act (Grassley) - drug pricing S. 3067, Non-Opioids Prevent Addiction In the Nation Act (Capito) - non-opioid treatments S. 3092, Expanding Access to Low-Cost Generics Act of 2019 (Smith) - exclusivity period H.R. 3, Lower Drug Costs Now Act of 2019 (Pallone)-drug pricing H.R. 465, Prescription Drug Price Relief Act (Khanna) - reforms linked to international pricing H.R. 478, Safe and Affordable Drugs from Canada Act (Pingree) - drug importation H.R. 938, BLOCKING Act (Schrader) - changes to 180-day period of market exclusivity for first generic applicant H.R. 965, CREATES Act (Cicilline) - removing barriers to generic drugs H.R. 985, FAST Generics Act (Welch) - removing barriers to generic drugs H.R. 990, Hatch-Waxman Integrity Act (Flores) - inter partes review process H.R. 1093, Stop Price Gouging Act (Pocan) - excise tax for drugs that have price spikes H.R. 1188, FLAT Prices Act (Golden) - reforms for drugs with sudden price spikes H.R. 1344, Competitive DRUGS Act (Doggett) - prohibiting pay-for-delay agreements H.R. 1419, Public Option Deficit Reduction Act (DeFazio) - public option H.R. 1499, Protecting Consumer Access to Generic Drugs Act (Rush) - prohibiting pay-for-delay agreements H.R. 1503, Orange Book Transparency Act (Kelly) - removal of invalidated patents from Orange Book H.R. 1506, FAIR Generics Act (Barragan) - changes to 180-day period of market exclusivity for first generic applicant H.R. 1520, Purple Book Continuity Act (Eshoo) - access to updated information on biologics and biosimilars H.R. 2038, State-Based, Market-Oriented Prescription Drug Negotiations Act (Meadows) - drug price negotiations H.R. 2064, Sunshine for Samples Act (Chu) - reporting requirements on drug samples H.R. 2069, SPIKE Act (Horsford) -justification for drug price increases H.R. 2087, Drug Price Transparency Act (Doggett) - reporting of drug pricing data under Medicare Part B H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting Act (Neal) - transparency in drug pricing H.R. 2115, Public Disclosure of Drug Discounts Act (Spanberger) - disclosure of negotiated Rx discounts H.R. 2279, Safe Step Act (Ruiz) - exceptions process for medication step therapy H.R. 2296, FAIR Drug Pricing Act (Schakowsky) - transparency requirements and justification for high list prices and drug price increases H.R. 2374, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Jeffries) - citizen petition process H.R. 2375, Preserve Access to Affordable Generics and Biosimilars Act (Nadler) - prohibiting pay-for-delay agreements H.R. 2376, Prescription Pricing for the People Act (Collins) - FTC study on role of PBMs and competition and transparency in pharmaceutical supply chain H.R. 3379, Price Relief, Innovation, and Competition for Essential Drugs Act (Schakowsky) - exclusivity period for biological products H.R. 3805, Prescription Drug Rebate Reform Act of 2019 (Gallagher)- drug rebates H.R. 3927, PDMPs Help Patients Act of 2019 (McKinley)-integrating SUDs and behavioral health into PDMPs H.R. 3947, Competition Prescription Act of 2019 (Meadows)- drug pricing H.R. 4010, Emergency Access to Insulin Act of 2019 (Craig)- drug pricing H.R. 4106, Responsibility in Drug Advertising Act of 2019 (DeLauro)-transparency in drug pricing H.R. 4244, MAGIC Act (Kelly)-pathways for insulin approval H.R. 4398, Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (Cicilline)-drug pricing H.R. 4455, BIOSIM Act (Schrader)-access to biosimilars H.R. 4460, Turn the Tide Act (Kuster)-Opioids H.R. 4538, Closing Loopholes for Orphan Drugs Act (Welch)-Access to drugs H.R. 4640, Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2019 (DeFazio) - direct negotiation H.R. 4712, Fairness in Orphan Drug Exclusivity Act (Dean) - limitations on exclusive approval of orphan drugs H.R. 4810, Opioid Prescription Verification Act of 2019 (David) - dispensing of controlled substances H.R. 4906, Insulin Price Reduction Act (Diana DeGette) - insulin costs H.R. 5304, PBM Transparency in Prescription Drug Costs Act (Schrader) - PBMs H.R. 5364, End Price Gouging for Insulin Act (Beatty) - annual reference price for insulin products H.R. 5430, United States-Mexico-Canada Agreement Implementation Act (Hoyer) - drug pricing H.R. 5442, Lowest Price for Patients Act (Porter) - pharmacies to disclose any differential between the cost of a prescription drug H.R. 5444, Lower Insulin Costs Now Act (Underwood) - lowering insulin costs H.Con.Res. 55, Expressing the sense of Congress on the need to inform American consumers with more balanced purchasing information for prescription drugs through the disclosure of price information in direct-to-consumer (DTC) advertisements. (Burgess)-drug pricing Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Support HR 1763/ S 348, Resident Physician Shortage Reduction Act of 2019, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions; Oppose HR 506,Hospital Competition Act of 2019, a bill to amend title XVIII of the Social Security Act to increase hospital competition; Statement submitted to the House Judiciary on the hearing "Diagnosing the Problem: Exploring the Effects of Consolidation and Anticompetitive Conduct in Health Care Markets";Letter of support for the Senate Workgroups efforts to ensure consumer protections by addressing surprise medical bills and comments on the development of legislation to protect patients from surprise medical bills; Letter urging Congress and the Administration to take further action to help reduce input and administrative costs, as well as maximize the number of insured patients; Comment letter urged CMS to extend the comment period for the proposed rules related to interoperability provisions of the 21st Century Cures Act by at least 30 days; Comment letter on the Food and Drug Administrations (FDA) draft guidance on blood glucose monitoring test systems (BGMS) for prescription point-of-care (POC) use and urge FDA to consider compiling a finite list of universally acceptable disinfectant products that would apply to all medical devices or classes of device; Comment letter that urged CMS to address the substantial flaws in the star ratings methodology since the ratings inception in 2016 and to suspend the display of overall star ratings on Hospital Compare while the agency continues its important work of enhancing the validity and meaningfulness of star ratings; Comment letter to FDA on the public meeting, Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions with the following legislative recommendations: Strengthen manufacturers drug shortage disclosure requirements, Incentivize manufacturing contingency plans and/or redundancies, Enhance production transparency requirements, Enact shortage disclosure notification requirements for certain medical devices needed to administer drugs, Assess drug shortages as a national security threat, Include potential risk for drug shortages as a factor in the Federal Trade Commission (FTC) reviews of drug company merger proposals, and regulatory recommendations: Establish incentives to encourage manufacturers to produce drugs in shortage, Prevent manufacturing shutdowns, Establish a quality manufacturing initiative, Enhance information on the quality of outsourcing facilities compounding, Expand and improve the FDAs drug shortages list, Develop a list of critical drugs, Consider how reducing the number of unapproved drugs1 on the market might impact shortages, Reduce drug waste, Create an Office of Clinical Affairs within the Drug Enforcement Administration (DEA); Comment letter urging the CMS to use its upcoming proposed rules for Inpatient Rehabilitation Facility (IRF) and other post-acute care providers to address several issues related to the implementation of the revised case-mix grouping (CMG) policies; Support HR 965/ S340, Creating and Restoring Equal Access to Equivalent Samples Act of 2019 or the CREATES Act of 2019, a bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products; Support HR 986/ S466 Protecting Americans with Preexisting Conditions Act of 2019, a bill provide that certain guidance related to waivers for State innovation under the Patient Protection and Affordable Care Act shall have no force or effect; Support HR 987 Strengthening Health Care and Lowering Prescription Drug Costs Act, a bill to amend the Patient Protection and Affordable Care Act to provide for Federal Exchange outreach and educational activities; Support HR 938 Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 or the BLOCKING Act of 2019, a bill to amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes; Support HR 1010, a bill to provide that the rule entitled Short-Term, Limited Duration Insurance shall have no force or effect; Support HR 1499 Protecting Consumer Access to Generic Drugs Act of 2019, a bill to prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes; Support HR 1425 State Health Care Premium Reduction Act, a bill to amend the Patient Protection and Affordable Care Act to provide for a Improve Health Insurance Affordability Fund to provide for certain reinsurance payments to lower premiums in the individual health insurance market; Support HR 1386/ S 1905 Expand Navigators Resources for Outreach, Learning, and Longevity Act of 2019 or the ENROLL Act of 2019,a bill to amend the Patient Protection and Affordable Care Act to provide for additional requirements with respect to the navigator program, and for other purposes; Support HR 1520 Purple Book Continuity Act of 2019, a bill to amend the Public Health Service Act to provide for the publication of a list of licensed biological products, and for other purposes; Support HR 1503 Orange Book Transparency Act of 2019A bill that would increase transparency for the patent status of both approved biological products and approved drugs; Support HR 2439/ HR 3414 Opioid Workforce Act of 2019, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions to help combat the opioid crisis; Submitted statement to the House Committee on Ways and Means Overcoming Racial Disparities and Social Determinants in the Maternal Mortality Crisis sharing information regarding hospitals and health systems efforts to address maternal morbidity and mortality, as we seek ways to improve outcomes and reduce health inequities for expectant and new mothers, and give their children the best possible start in life; Submitted oral and written testimony to the House Committee on Ways and Means Subcommittee on Health Hearing on Protecting Patients from Surprise Medical Bills. Protecting patients from surprise medical bills is a top priority and we have adopted a set of guiding principles to use as we evaluate legislative proposals: Define surprise bills, Protect the patient financially, Ensure patient access to emergency care, Preserve the role of private negotiation, Remove the patient from health plan/provider negotiations, Educate patients about their health care coverage, Ensure patients have access to comprehensive provider networks and accurate network information, and Support state laws that work; Letters submitted to the Energy & Commerce Committee in response to the request for comments on their surprise billing discussion draft. Concerned with the Committees draft legislations approach to determining reimbursement for out-of-network providers. Once the patient is protected from surprise bills, providers and insurers should then be permitted to negotiate payment rates for services provided. We strongly oppose approaches that would impose arbitrary rates on providers. We look forward to continuing to work with the Committee on solutions to stop surprise medical bills; Letter sent to the HELP Committee in response to the Lower Health Care Costs Act of 2019 discussion draft about our concerns about several of the proposals that would allow the government to intrude into private commercial contracts between providers and insurers. For example, several of the provisions could undermine value-based purchasing arrangements aimed directly at improving the quality of care while reducing costs. We strongly urge the Committee to remove these provisions; Submitted oral and written testimony to the House Committee on Energy and Commerce, Subcommittee on Health Hearing on No More Surprises: Protecting Patients from Surprise Medical Bills asking that the Committee preserve the ability of providers and insurers to negotiate private contracts and not establish a fixed payment amount for out-of-network services; Oppose HR 1309 Workplace Violence Prevention for Health Care and Social Service Workers Act, a bill to direct the Secretary of Labor to issue an occupational safety and health standard that requires covered employers within the health care and social service industries to develop and implement a comprehensive workplace violence prevention plan, and for other purposes; Concerns about S.1531, Stopping The Outrageous Practice of Surprise Medical Bills Act of 2019 or the STOP Surprise Medical Bills Act of 2019, to amend the Public Health Service Act to provide protections for health insurance consumers from surprise billing; Concerns about S. 1895 Lower Health Care Costs Act Letter addressed concerns about the legislative provision that sets a benchmark rate in statute for the out-of-network payments, as well as provisions that seek to change privately negotiated contracting arrangements between hospitals and insurance companies; Support HR 3425, Advancing Medical Resident Training in Community Hospitals Act of 2019, to amend title XVIII of the Social Security Act to establish rules for payment for graduate medical education (GME) costs for hospitals that establish a new medical residency training program after hosting resident rotators for short durations; Expressed concerns regarding the provisions that reduce reimbursements to providers and hospitals that administer drugs the Prescription Drug Pricing Reduction Act (PDPRA) of 2019: including about Section 107, Medicare Part B Rebate by Manufacturers for Drugs or Biologicals with Prices Increasing Faster than Inflation, Section 110, Establishment of Maximum Add-on Payment for Drugs, Biologicals, and Biosimilars, this provision would establish $1,000 as the maximum add-on amount that a provider can be paid for a separately payable drug, biological or biosimilar, Section 111, Treatment of Drug Administration Services Furnished by an Off-Campus Outpatient Department of a Provider, the site neutral payment reduction would cut aggregate hospital payments; Support S. 2091, Backlog Elimination, Legal Immigration, and Employment Visa Enhancement Act, this legislation would increase the total number of employment-based visas from 140,000 to 270,000 and ensure that critical health care workers needed in the U.S. have access to employment-based visas by carving out health care workers in designated shortage occupations from the limit; Support S 350, The Competitive Health Insurance Reform Act of 2019, a bill to restore the application of the Federal antitrust laws to the business of health insurance to protect competition and consumers; Support letter for the adoption of a unique patient identifier (UPI, by removing the prohibition on the use of federal funds to promulgate or adopt a national UPI would provide HHS the ability to explore solutions that link patients with their correct medical records; Submitted statement to Subcommittee on Health of the Committee on Energy and Commerce for the hearing on Improving Maternal Health: Legislation to Advance Prevention Efforts and Access to Care; Concerns with S. 386 and HR 1044, Fairness for High-Skilled Immigrants Act of 2019, this bill increases the per-country cap on family-based immigrant visas from 7% of the total number of such visas available that year to 15%, and eliminates the 7% cap for employment-based immigrant visas. It also removes an offset that reduced the number of visas for individuals from China; Support H.R. 4538, Closing Loopholes for Orphan Drugs Act, a bill to amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title; Discussions of provisions we support and those we recommend be changes in a draft bill called the Mitigating Existing Drug Shortages (MEDS) Act; Discussions in support of the allowing states to designate hospitals as necessary providers for purposes of waiving the critical access hospital mileage requirements; Provided comments to W&M on legislation to expand Health Profession Opportunity Grants; Support H.R. 2723, The Mitigating Emergency Drug Shortages (MEDS) Act, a bill to amend Sec. 506C of the Federal Food, Drug, and Cosmetic Act which strengthens requirements for drug manufacturers to disclose the root causes and expected duration of shortages, extends reporting requirements to active pharmaceutical ingredients manufacturers, requires manufacturers have contingency plans to ensure ongoing supply, develops recommendations to incentivize manufacturers to enter the market for drugs in shortage and examines the national security risks of shortages; DEA reductions in annual quotas for opioid products used by hospitals for sedation and pain management; Meeting with the Office of the Assistant Secretary of Preparedness and Response (ASPR) to discuss developments in the hospital preparedness program, the pilot projects for the Regional Disaster Healthcare System and other issues; Rural access to health care, including identifying core services needed in rural communities, outlining approaches and considerations for delivering those services, and examining access and quality in the rural context; ONCs proposed rule to implement the 21st Century Cures provision on information blocking; Supported members serving on the HHS Quality Summit panel, which was convened by the Deputy Secretary to gather input regarding how to improve and energize quality and safety improvement activities across health care system; Discussion with HHS on drug pricing, 340b, and price transparency policies, as well as the International Pricing Index ANPRM; Discussion with HHS about the work of Aligning for Health to address social determinants of health; Support S 2902, Strengthening Our Rural Health Workforce Act of 2019, a bill to enhance the rural health workforce; Meetings and correspondence with staff members of Senate Financing Committee on a proposal to support rural health care access (REH, re-opening necessary provider CAH, infrastructure funding); Letter to Ways & Means committee Rural and Underserved Communities Health Task Force in response to RFI on factors that contribute to health outcomes in these areas, examples of successful models and lessons from the field that address access and outcomes, and considerations for the unique circumstances of rural and underserved communities; Letter to Energy and Commerce Members regarding health information technology priorities; Letter of Support to Senate Appropriations on funding for the Centers for Disease Control and Prevention and the National Institutes of Health to study gun violence; Support S.2741 and H.R. 4932,Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019, a bill to amend title XVIII of the Social Security Act to expand access to telehealth services, and for other purposes; Support S 2603, Resolving Extended Limbo for Immigrant Employees and Families (RELIEF) Act, a bill to amend the Immigration and Nationality Act to end the immigrant visa backlog, and for other purposes; Support HR 4995, Maternal Health Quality Improvement Act of 2019, a bill to amend the Public Health Service Act to improve obstetric care and maternal health outcomes, and for other purposes.

H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release (FAIR) of Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1922: Restoring Access to Medication Act of 2019 - Provisions related to prescription drug access H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes - Provisions related to prescription drug samples H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples H.R. 2296: FAIR Drug Pricing Act of 2019 / More Efficient Tools to Realize Information for Consumers Act - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2569: Comprehensive Addiction Resources Emergency Act of 2019 - Provisions related to opioid crisis response funding H.R. 2732: Lessening Addiction By Enhancing Labeling Opioids Act of 2019 - Provisions related to labeling of prescription drugs H.R. 2734: Safer Prescribing of Controlled Substances Act - Provisions related to the prescribing of prescription drugs H.R. 2917: Opioid Crisis Accountability Act of 2019 - Provisions related to prescription drug marketing H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 3327: Drug Price Transparency for Medicare Patients Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 3415: Real-Time Beneficiary Drug Cost Bill - Provisions related to drug pricing transparency H.R. 3947: Competition Prescription Act of 2019 - Provisions related to prescription drug pricing, patents, and other provisions H.R. 4010: Emergency Access to Insulin Act of 2019 - Provisions related to prescription drug access programs H.R. 4106: Responsibility in Drug Advertising Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 4158: CURE High Drug Prices Act - Provisions related to prescription drug pricing and transparency H.R. 4439: Creating Hope Reauthorization Act - Provisions related to rare disease priority review vouchers H.R. 4538: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B prescription drug exclusions H.R. 4633: Investing in Safety and Innovation Act of 2019 - Provisions related to FDA programs reauthorization H.R. 4640: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2019 - Provisions related to prescription drug pricing and negotiation H.R. 4667: Biomedical Innovation Expansion Act of 2019 - Provisions related to NIH programs reauthorization H.R. 4710: Pharmaceutical Independence Long-Term Readiness Reform Act - Provisions related to the supply chain H.R. 4711: No Tax Breaks for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising H.R. 4812: Ensuring Compliance Against Drug Diversion Act of 2019 - Provisions related to registrations under the Controlled Substances Act H.R. 4814: Suspicious Order Identification Act of 2019 - Provisions related to reporting on distribution of controlled substances H.R. 4906: Insulin Price Reduction Act - Provisions related to prescription drug pricing and transparency H.R. 4963: Stop the Importation and Manufacturing of Synthetic Analogues Act of 2019 - Provisions related to synthetic analogues H.R. 5031: Medical Innovation Act of 2019 - Provisions related to prescription drug manufacturer taxation and supplemental fees H.R. 5198: Patients' Right to Know Their Medication Act of 2019 - Provisions related to prescription drug labeling H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 5304: PBM Transparency in Prescription Drug Costs Act - Provisions related to prescription drug pricing transparency H.R. 5381: International Pharmaceutical Transparency Act of 2019 - Provisions related to prescription drug labeling H.R. 5382: To create a mechanism whereby insulin manufacturers may sell directly to consumers at current net prices - Provisions related to prescription drug pricing H.R. 5442: To amend title XXVII of the Public Health Service Act and title XVIII of the Social Security Act to require pharmacies to disclose any differential between the cost of a prescription drug based on whether certain individuals use prescription drug coverage to acquire such drug, and for other purposes - Provisions related to prescription drug pricing and transparency H.R. 5497: Conditional Approval Act - Provisions related to approval pathway S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1250: American Cures Act - Provisions related to pharmaceutical research and development S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 2004: Emergency Access to Insulin Act of 2019 - Provisions related to prescription drug pricing S. 2103: Affordable Insulin Approvals Now Act - Provisions related to FDA prescription drug approvals S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2199: Insulin Price Reduction Act - Provisions related to prescription drug pricing and transparency S. 2723: Mitigating Emergency Drug Shortages Act - Provisions related to prescription drug pricing transparency and other provisions S. 2897: Patient-Centered Outcomes Research Institute Reauthorization Act - Provisions related to PCORI reauthorization Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49) Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45)

H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation ___ H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation ___ H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems ___ H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1922/S. 1089 _ Restoring Access to Medicine Act ___ H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing ___ H.R. 1332: Fair Care Act of 2019 - Provisions related to prescription drug pricing, patent issues, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems ___ H.R. 1409: Transparency in All Health Care Pricing Act of 2019 - Provisions related to prescription drug pricing transparency ___ H.R. 1506: Fair and Immediate Release of (FAIR) Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1973: Vaccine Access Improvement Act ___ H.R. 2011: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products ___ H.R. 2038: State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 - Provisions related to prescription drug pricing ___ H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes - Provisions related to prescription drug samples ___ H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs ___ H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency ___ H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples ___ H.R. 2115: Public Disclosure of Drug Discounts Act - Provisions related to prescription drug pricing transparency and pharmacy benefit managers ___ H.R. 2296: FAIR Drug Pricing Act of 2019 / More Efficient Tools to Realize Information for Consumers Act - Provisions related to prescription drug pricing and transparency ___ H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers ___ H.R. 2401: American Cures Act - Provisions related to pharmaceutical research and development ___ H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers ___ H.R. 3327: Drug Price Transparency for Medicare Patients Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising ___ H.R. 3415: Real-Time Beneficiary Drug Cost Bill - Provisions related to drug pricing transparency ___ H.R. 3443: Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 - Provisions related to FDA over-the-counter drug approvals ___ H.R. 3947: Competition Prescription Act of 2019 - Provisions related to prescription drug pricing, patents, and other provisions ___ H.R. 4106: Responsibility in Drug Advertising Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising ___ H.R. 4158: CURE High Drug Prices Act - Provisions related to prescription drug pricing and transparency ___ H.R. 4538: To amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title. - Provisions related to 340B prescription drug exclusions ___ S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation ___ S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising ___ S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation ___ S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems ___ S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing ___ S. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes ___ S. 474: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs ___ S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency ___ S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates ___ S. 658: Accelerated Drug Approval for Prescription Therapies Act - Provisions related to FDA drug approvals ___ S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process ___ S. 844: Short on Competition Act - Provisions related to generic prescription drug approvals and importation ___ S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to pharmaceutical drug pricing ___ S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products ___ S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers ___ S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and commercial rebates ___ S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency ___ S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising ___ S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers ___ S. 1664: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency S.1872 _ Protecting Seniors through Immunizations Act of 2019 ___ S. 2387: We Protect American Investment in Drugs Act - Provisions related to prescription drug pricing ___ Transparency policy issues ___ Drug cost and pricing policy issues ___ Drug importation and counterfeiting policy issues ___ HHS Safe Importation Action Plan ___ Prescription drug take back and secure disposal policy issues ___ Policy issues related to prescription drug abuse and opioids ___ Expanded access policy issues ___ Generic drug approval process policy issues ___ High deductible health plans/HSA policy issues ___ Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors ___ Risk Evaluation and Mitigation Strategy (REMS) policy issues ___ FDA modernization policy issues ___ PDUFA implementation policy issues ___ 340B drug discount program policy issues ___ Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions ___ Patient assistance program policy issues ___ Biosimilar approval and reimbursement policy issues ___ Cancer drug vial size policy issues ___ TRICARE pharmacy pilot program ___ Drug shortages policy issues ___ Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

Support HR 1763/ S 348, Resident Physician Shortage Reduction Act of 2019, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions; Oppose HR 506,Hospital Competition Act of 2019, a bill to amend title XVIII of the Social Security Act to increase hospital competition; Statement submitted to the House Judiciary on the hearing "Diagnosing the Problem: Exploring the Effects of Consolidation and Anticompetitive Conduct in Health Care Markets";Letter of support for the Senate Workgroups efforts to ensure consumer protections by addressing surprise medical bills and comments on the development of legislation to protect patients from surprise medical bills; Letter urging Congress and the Administration to take further action to help reduce input and administrative costs, as well as maximize the number of insured patients; Comment letter urged CMS to extend the comment period for the proposed rules related to interoperability provisions of the 21st Century Cures Act by at least 30 days; Comment letter on the Food and Drug Administrations (FDA) draft guidance on blood glucose monitoring test systems (BGMS) for prescription point-of-care (POC) use and urge FDA to consider compiling a finite list of universally acceptable disinfectant products that would apply to all medical devices or classes of device; Comment letter that urged CMS to address the substantial flaws in the star ratings methodology since the ratings inception in 2016 and to suspend the display of overall star ratings on Hospital Compare while the agency continues its important work of enhancing the validity and meaningfulness of star ratings; Comment letter to FDA on the public meeting, Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions with the following legislative recommendations: Strengthen manufacturers drug shortage disclosure requirements, Incentivize manufacturing contingency plans and/or redundancies, Enhance production transparency requirements, Enact shortage disclosure notification requirements for certain medical devices needed to administer drugs, Assess drug shortages as a national security threat, Include potential risk for drug shortages as a factor in the Federal Trade Commission (FTC) reviews of drug company merger proposals, and regulatory recommendations: Establish incentives to encourage manufacturers to produce drugs in shortage, Prevent manufacturing shutdowns, Establish a quality manufacturing initiative, Enhance information on the quality of outsourcing facilities compounding, Expand and improve the FDAs drug shortages list, Develop a list of critical drugs, Consider how reducing the number of unapproved drugs1 on the market might impact shortages, Reduce drug waste, Create an Office of Clinical Affairs within the Drug Enforcement Administration (DEA); Comment letter urging the CMS to use its upcoming proposed rules for Inpatient Rehabilitation Facility (IRF) and other post-acute care providers to address several issues related to the implementation of the revised case-mix grouping (CMG) policies; Letter sent to the Congressional Telehealth Caucus with recommendations to improve and expand access to telehealth; Support HR 965/ S340, Creating and Restoring Equal Access to Equivalent Samples Act of 2019 or the CREATES Act of 2019, a bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products; Support HR 986/ S466 Protecting Americans with Preexisting Conditions Act of 2019, a bill provide that certain guidance related to waivers for State innovation under the Patient Protection and Affordable Care Act shall have no force or effect; Support HR 987 Strengthening Health Care and Lowering Prescription Drug Costs Act, a bill to amend the Patient Protection and Affordable Care Act to provide for Federal Exchange outreach and educational activities; Support HR 938Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 or the BLOCKING Act of 2019, a bill to amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes; Support HR 1010, a bill to provide that the rule entitled Short-Term, Limited Duration Insurance shall have no force or effect; Support HR 1499 Protecting Consumer Access to Generic Drugs Act of 2019, a bill to prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes; Support HR 1425 State Health Care Premium Reduction Act, a bill to amend the Patient Protection and Affordable Care Act to provide for a Improve Health Insurance Affordability Fund to provide for certain reinsurance payments to lower premiums in the individual health insurance market; Support HR 1386/ S 1905Expand Navigators Resources for Outreach, Learning, and Longevity Act of 2019 or the ENROLL Act of 2019,a bill to amend the Patient Protection and Affordable Care Act to provide for additional requirements with respect to the navigator program, and for other purposes; Support HR 1520 Purple Book Continuity Act of 2019, a bill to amend the Public Health Service Act to provide for the publication of a list of licensed biological products, and for other purposes; Support HR 1503 Orange Book Transparency Act of 2019A bill that would increase transparency for the patent status of both approved biological products and approved drugs; Support HR 2439/ HR 3414 Opioid Workforce Act of 2019, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions to help combat the opioid crisis; Submitted statement to the House Committee on Ways and Means Overcoming Racial Disparities and Social Determinants in the Maternal Mortality Crisis sharing information regarding hospitals and health systems efforts to address maternal morbidity and mortality, as we seek ways to improve outcomes and reduce health inequities for expectant and new mothers, and give their children the best possible start in life; Submitted oral and written testimony to the House Committee on Ways and Means Subcommittee on Health Hearing on Protecting Patients from Surprise Medical Bills. Protecting patients from surprise medical bills is a top priority and we have adopted a set of guiding principles to use as we evaluate legislative proposals: Define surprise bills, Protect the patient financially, Ensure patient access to emergency care, Preserve the role of private negotiation, Remove the patient from health plan/provider negotiations, Educate patients about their health care coverage, Ensure patients have access to comprehensive provider networks and accurate network information, and Support state laws that work; Letters submitted to the Energy & Commerce Committee in response to the request for comments on their surprise billing discussion draft. Concerned with the Committees draft legislations approach to determining reimbursement for out-of-network providers. Once the patient is protected from surprise bills, providers and insurers should then be permitted to negotiate payment rates for services provided. We strongly oppose approaches that would impose arbitrary rates on providers. We look forward to continuing to work with the Committee on solutions to stop surprise medical bills; Letter sent to the HELP Committee in response to the Lower Health Care Costs Act of 2019 discussion draft about our concerns about several of the proposals that would allow the government to intrude into private commercial contracts between providers and insurers. For example, several of the provisions could undermine value-based purchasing arrangements aimed directly at improving the quality of care while reducing costs. We strongly urge the Committee to remove these provisions; Submitted oral and written testimony to the House Committee on Energy and Commerce, Subcommittee on Health Hearing on No More Surprises: Protecting Patients from Surprise Medical Bills asking that the Committee preserve the ability of providers and insurers to negotiate private contracts and not establish a fixed payment amount for out-of-network services; Oppose HR 1309 Workplace Violence Prevention for Health Care and Social Service Workers Act, a bill to direct the Secretary of Labor to issue an occupational safety and health standard that requires covered employers within the health care and social service industries to develop and implement a comprehensive workplace violence prevention plan, and for other purposes; Concerns about S.1531, Stopping The Outrageous Practice of Surprise Medical Bills Act of 2019 or the STOP Surprise Medical Bills Act of 2019, to amend the Public Health Service Act to provide protections for health insurance consumers from surprise billing; Submitted oral and written testimony to the Senate Committee on Health, Education, Labor and Pensions Hearing: Lower Health Care Costs Act to express concerns about several proposals that would allow the government to intrude into private commercial contracts between providers and insurers, which could undermine value-based purchasing arrangements aimed directly at improving the quality of care while reducing costs and the impact on rural communities. We strongly urge the Committee to remove these provisions; Concerns about S. 1895 Lower Health Care Costs Act Letter addressed concerns about the legislative provision that sets a benchmark rate in statute for the out-of-network payments, as well as provisions that seek to change privately negotiated contracting arrangements between hospitals and insurance companies; Support HR 3425, Advancing Medical Resident Training in Community Hospitals Act of 2019, to amend title XVIII of the Social Security Act to establish rules for payment for graduate medical education (GME) costs for hospitals that establish a new medical residency training program after hosting resident rotators for short durations; Expressed concerns regarding the provisions that reduce reimbursements to providers and hospitals that administer drugs the Prescription Drug Pricing Reduction Act (PDPRA) of 2019: including about Section 107, Medicare Part B Rebate by Manufacturers for Drugs or Biologicals with Prices Increasing Faster than Inflation, Section 110, Establishment of Maximum Add-on Payment for Drugs, Biologicals, and Biosimilars, this provision would establish $1,000 as the maximum add-on amount that a provider can be paid for a separately payable drug, biological or biosimilar, Section 111, Treatment of Drug Administration Services Furnished by an Off-Campus Outpatient Department of a Provider, the site neutral payment reduction would cut aggregate hospital payments; Support S. 2091, Backlog Elimination, Legal Immigration, and Employment Visa Enhancement Act, this legislation would increase the total number of employment-based visas from 140,000 to 270,000 and ensure that critical health care workers needed in the U.S. have access to employment-based visas by carving out health care workers in designated shortage occupations from the limit; Support S 350, The Competitive Health Insurance Reform Act of 2019, a bill to restore the application of the Federal antitrust laws to the business of health insurance to protect competition and consumers; Support letter for the adoption of a unique patient identifier (UPI, by removing the prohibition on the use of federal funds to promulgate or adopt a national UPI would provide HHS the ability to explore solutions that link patients with their correct medical records; Submitted statement to Subcommittee on Health of the Committee on Energy and Commerce for the hearing on Improving Maternal Health: Legislation to Advance Prevention Efforts and Access to Care; Concerns with S. 386 and HR 1044, Fairness for High-Skilled Immigrants Act of 2019, this bill increases the per-country cap on family-based immigrant visas from 7% of the total number of such visas available that year to 15%, and eliminates the 7% cap for employment-based immigrant visas. It also removes an offset that reduced the number of visas for individuals from China; Support H.R. 4538, Closing Loopholes for Orphan Drugs Act, a bill to amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title; Discussions of provisions we support and those we recommend be changes in a draft bill called the Mitigating Existing Drug Shortages (MEDS) Act; Discussions in support of the allowing states to designate hospitals as necessary providers for purposes of waiving the critical access hospital mileage requirements; Provided comments to W&M on legislation to expand Health Profession Opportunity Grants.

H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1332: Fair Care Act of 2019 - Provisions related to prescription drug pricing, patent issues, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1409: Transparency in All Health Care Pricing Act of 2019 - Provisions related to prescription drug pricing transparency H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release (FAIR) of Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1603: Alan Reinstein Ban Asbestos Now Act of 2019 - Provisions related to use of asbestos in manufacturing H.R. 2038: State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 - Provisions related to prescription drug pricing H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes - Provisions related to prescription drug samples H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples H.R. 2115: Public Disclosure of Drug Discounts Act - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2296: FAIR Drug Pricing Act of 2019 / More Efficient Tools to Realize Information for Consumers Act - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2401: American Cures Act - Provisions related to pharmaceutical research and development H.R. 2569: Comprehensive Addiction Resources Emergency Act of 2019 - Provisions related to opioid crisis response funding H.R. 2734: Safer Prescribing of Controlled Substances Act - Provisions related to the prescribing of prescription drugs H.R. 2917: Opioid Crisis Accountability Act of 2019 - Provisions related to prescription drug marketing H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 3327: Drug Price Transparency for Medicare Patients Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 3415: Real-Time Beneficiary Drug Cost Bill - Provisions related to drug pricing transparency H.R. 3443: Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 - Provisions related to FDA over-the-counter drug approvals H.R. 3947: Competition Prescription Act of 2019 - Provisions related to prescription drug pricing, patents, and other provisions H.R. 4106: Responsibility in Drug Advertising Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 4158: CURE High Drug Prices Act - Provisions related to prescription drug pricing and transparency H.R. 4538: To amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title. - Provisions related to 340B prescription drug exclusions S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes S. 474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 844: Short on Competition Act - Provisions related to generic prescription drug approvals and importation S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to pharmaceutical drug pricing S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and commercial rebates S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1664: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency S. 2103: Affordable Insulin Approvals Now Act - Provisions related to FDA prescription drug approvals S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2199: Insulin Price Reduction Act - Provisions related to prescription drug pricing and transparency S. 2387: We Protect American Investment in Drugs Act - Provisions related to prescription drug pricing Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

S. 61, Safe and Affordable Drugs from Canada Act (Grassley) - drug importation S. 64, Preserve Access to Affordable Generics and Biosimilars Act (Grassley-Klobuchar) - prohibiting pay-for-delay settlements S. 73, End Taxpayer Subsidies for Drug Ads Act (Shaheen) - prohibiting tax deduction for DTC advertising expenses S. 102, Prescription Drug Price Relief Act (Sanders) - reforms linked to international pricing S. 340, CREATES Act (Leahy) - removing barriers to generic drugs S. 344, Hatch-Waxman Integrity Act (Tillis) - inter partes review process S. 366, FLAT Prices Act (Durbin) - reforms for drugs with sudden price spikes S. 378, Stop Price Gouging Act (Durbin) - excise tax for drugs that have price spikes S. 440, Preserving Access to Cost-Effective Drugs Act (Cotton) - sovereign immunity and Inter Partes Review process S. 474, SPIKE Act (Wyden) - justification for drug price increases S. 476, Creating Transparency to Have Drug Rebates Unlocked Act (Wyden) - drug price transparency S. 637, CURE High Drug Prices Act (Blumenthal) - remedies for price gouging S. 657, Point of Sale Rebates (Braun) S. 659, Biologic Patent Transparency Act (Collins) - patent disclosure requirements S. 660, Efficiency and Transparency in Petitions Act (Braun) - FDA citizen petition process S. 844, Short on Competition Act (Klobuchar) - remedies for marginally competitive drug markets S. 977, Transparency Drug Pricing Act (Scott) - transparency and drug pricing reforms S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act (Cassidy) - preventing evergreening of patent protections S. 1224, Stop STALLING Act (Klobuchar) - citizen petition process S. 1227, Prescription Pricing for the People Act (Grassley) - FTC report on role of PBMs and allegations of anticompetitive conduct by manufacturers of sole-source drugs S. 1384, Prescription Drug Rebate Reform Act (Romney-Braun) - prescription drug cost sharing S. 1416, Affordable Prescriptions for Patients Act (Cornyn) - product hopping, patent thickets S. 1664, Prescription Drug Price Reporting Act (Scott) - prescription drug price reporting S. 2247, Phair Relief Act of 2019 (Kennedy)-transparency around price concessions for drugs S. 2387, We Protect American Investment in Drugs Act (Van Hollen)-drug pricing S. 2543, Prescription Drug Pricing Reduction Act of 2019 (Grassley)-Drug pricing H.R. 3, Lower Drug Costs Now Act of 2019 (Pallone)-drug pricing H.R. 465, Prescription Drug Price Relief Act (Khanna) - reforms linked to international pricing H.R. 478, Safe and Affordable Drugs from Canada Act (Pingree) - drug importation H.R. 938, BLOCKING Act (Schrader) - changes to 180-day period of market exclusivity for first generic applicant H.R. 965, CREATES Act (Cicilline) - removing barriers to generic drugs H.R. 985, FAST Generics Act (Welch) - removing barriers to generic drugs H.R. 990, Hatch-Waxman Integrity Act (Flores) - inter partes review process H.R. 1093, Stop Price Gouging Act (Pocan) - excise tax for drugs that have price spikes H.R. 1188, FLAT Prices Act (Golden) - reforms for drugs with sudden price spikes H.R. 1344, Competitive DRUGS Act (Doggett) - prohibiting pay-for-delay agreements H.R. 1419, Public Option Deficit Reduction Act (DeFazio) - public option H.R. 1499, Protecting Consumer Access to Generic Drugs Act (Rush) - prohibiting pay-for-delay agreements H.R. 1503, Orange Book Transparency Act (Kelly) - removal of invalidated patents from Orange Book H.R. 1506, FAIR Generics Act (Barragan) - changes to 180-day period of market exclusivity for first generic applicant H.R. 1520, Purple Book Continuity Act (Eshoo) - access to updated information on biologics and biosimilars H.R. 2038, State-Based, Market-Oriented Prescription Drug Negotiations Act (Meadows) - drug price negotiations H.R. 2064, Sunshine for Samples Act (Chu) - reporting requirements on drug samples H.R. 2069, SPIKE Act (Horsford) -justification for drug price increases H.R. 2087, Drug Price Transparency Act (Doggett) - reporting of drug pricing data under Medicare Part B H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting Act (Neal) - transparency in drug pricing H.R. 2115, Public Disclosure of Drug Discounts Act (Spanberger) - disclosure of negotiated Rx discounts H.R. 2279, Safe Step Act (Ruiz) - exceptions process for medication step therapy H.R. 2296, FAIR Drug Pricing Act (Schakowsky) - transparency requirements and justification for high list prices and drug price increases H.R. 2374, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Jeffries) - citizen petition process H.R. 2375, Preserve Access to Affordable Generics and Biosimilars Act (Nadler) - prohibiting pay-for-delay agreements H.R. 2376, Prescription Pricing for the People Act (Collins) - FTC study on role of PBMs and competition and transparency in pharmaceutical supply chain H.R. 3379, Price Relief, Innovation, and Competition for Essential Drugs Act (Schakowsky) - exclusivity period for biological products H.R. 3805, Prescription Drug Rebate Reform Act of 2019 (Gallagher)- drug rebates H.R. 3927, PDMPs Help Patients Act of 2019 (McKinley)-integrating SUDs and behavioral health into PDMPs H.R. 3947, Competition Prescription Act of 2019 (Meadows)- drug pricing H.R. 4010, Emergency Access to Insulin Act of 2019 (Craig)- drug pricing H.R. 4106, Responsibility in Drug Advertising Act of 2019 (DeLauro)-transparency in drug pricing H.R. 4244, MAGIC Act (Kelly)-pathways for insulin approval H.R. 4398, Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (Cicilline)-drug pricing H.R. 4455, BIOSIM Act (Schrader)-access to biosimilars H.R. 4460, Turn the Tide Act (Kuster)-Opioids H.R. 4538, Closing Loopholes for Orphan Drugs Act (Welch)-Access to drugs H.Con.Res. 55, Expressing the sense of Congress on the need to inform American consumers with more balanced purchasing information for prescription drugs through the disclosure of price information in direct-to-consumer (DTC) advertisements. (Burgess)-drug pricing Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

P.L. 111-203, Dodd-Frank Wall Street Reform and Consumer Protection Act, Title IX, Section 913, Securities and Exchange Commission Study and rulemaking regarding obligations of brokers, dealers, and investment advisers; H.R. 4538,

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

P.L. 111-203, Dodd-Frank Wall Street Reform and Consumer Protection Act, Title IX, Section 913, Securities and Exchange Commission Study and rulemaking regarding obligations of brokers, dealers, and investment advisers; H.R. 4538,

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

P.L. 111-203, Dodd-Frank Wall Street Reform and Consumer Protection Act, Title IX, Section 913, Securities and Exchange Commission Study and rulemaking regarding obligations of brokers, dealers, and investment advisers; H.R. 4538,

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE