Fair Accountability and Innovative Research Drug Pricing Act of 2017

S. 92: Safe and Affordable Drugs from Canada Act S. 201 / H.R. 5247: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 S. 469: Affordable and Safe Prescription Drug Importation Act S. 1131/ H.R. 2439: FAIR Drug Pricing Act S. 1827/ H.R. 3921 HEALTHY KIDS Act S. 2076 /H.R. 4256: Building Our Largest Dementia (BOLD) Infrastructure for Alzheimers Act S. 2260 / H.R. 4733: Opioids and STOP Pain Initiative Act H.R. 1625 Vehicle for Consolidated Appropriations Act 2018 H.R. 1776: Improving Access to Affordable Prescription Drugs Act H.R. 1876: Good Samaritan Health Professionals Act of 2017 H.R. 1892: Continuing Resolution through March 23, 2018 H.R. 2077: the Restoring the Patient's Voice Act of 2017 H.R. 4116: Transparent Drug Pricing Act of 2017 H.R. 4841: Legislation to improve electronic prior authorization use in Medicare Advantage Maintenance/expansion of Graduate Medical Education (GME); encouraging drug price transparency; NIH funding including the BRAIN Initiative; Congressionally-Directed Medical Research Program funding; concussion related issues.

Client expense: $620,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to S.2315 "Over-the-Counter Drug Safety, Innovation, and Reform Act; general issues related to drug pricing;issues related to cosmetic regulations; issues related to insulin pricing;issues related H.R. 6378 "Pandemic and All Hazards Preparedness (PAHPA)Advancing Innovation Act"; issues related to Medicare Part D; issues related to flu and Veterans Affairs; issues related to seasonal influenza vaccination; issues related to 340B Reform; issues related to Drug Importation; issues related to vaccine safety;issues related to HR5333 "Over-the-Counter Monograph Safety, Innovation, and reform Act of 2018; issues related to HR2212 "CREATES Act of 2017";issues related to HR 2439 "Fair Accountability and Innovation Research Drug Act of 2017"; issues related S. 2852 "Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPA) of 2018"; issues related to PAHPA reauthorization; and issues related to S.2465 "Sickle Cell Disease and other Heritable Blood Disorders Research, Surveillance, Prevention and Treatment Act of 2018"

Client expense: $790,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), SENATE

S. 297, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug costs S. 974, CREATES Act (Leahy-Grassley) - access to generic drugs and biosimilars S. 1115, Making Pharmaceutical Markets More Competitive Act (Collins-McCaskill) - accelerated approval of generic therapies S. 1131, FAIR Drug Pricing Act (Baldwin-McCain) - transparency in prescription drug pricing S. 2553, Know the Lowest Price Act (Stabenow) - pharmacist-patient communications S. 2554, Patient Right to Know Drug Prices Act (Collins) - pharmacist-patient communications, reporting of biosimilar pay-for-delay settlements S. 3194, Capping Prescription Costs Act (Warren) - capping prescription copays S. 3738, Hatch-Waxman Integrity Act (Hatch) - inter partes review process S. 3792, Preserve Access to Affordable Generics and Biosimilars Act (Klobuchar-Grassley) - pay-for-delay settlements H.R. 749, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug costs H.R. 1703, Medical Product Communication Act (Griffith) - off-label exchange of information H.R. 2026, Pharmaceutical Information Exchange Act (Guthrie) - pre-approval health care economic information to payors H.R. 2051, Fair Access for Safe and Timely Generics Act (McKinley-Welch) - access to generic drugs H.R. 2212, CREATES Act (Marino-Cicilline) - access to generic drugs and biosimilars H.R. 2439, FAIR Drug Pricing Act (Schakowsky) - transparency in prescription drug pricing H.R. 2562, Making Pharmaceutical Markets More Competitive Act (Kelly) - accelerated approval of generic therapies H.R. 2999, Patients' Access to Treatments Act (McKinley) - limiting cost sharing in specialty drug tiers H.R. 5247, Right to Try Act (Fitzpatrick) - use of unapproved investigational drugs by patients with life-threatening conditions H.R. 6142, Reducing Drug Waste Act (Doggett) - packaging of medications H.R. 6157, Defense-Labor-HHS-Education Appropriations Act (Granger) -pharmaceutical price transparency in DTC advertising H.R. 6340, Capping Prescription Costs Act (Rosen) - capping prescription copays H.R. 6478, Biosimilars Competition Act (Sarbanes) - reporting of pay-for-delay settlements H.R. 6576, Drug-Price Transparency in Communications Act (Schakowsky) - disclosure of drug prices in DTC advertising H.R. 6733, Know the Cost Act (Carter) - pharmacist-patient communications H.R. 7251, Hatch-Waxman Integrity Act (Flores) - inter partes review process 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; 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 relating to access for investigational drugs; and other issues relating to health care reform implementation.

Client expense: $1,540,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. S.3519: MODERN Labeling Act. Drug Compounding. Drug Shortages. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. S.3792: Preserve Access to Affordable Generics and Biosimilars Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Pharmaceutical Exclusivity. H.R.6577: PRICED Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. H.R.7348/S.3775: Affordable Drug Manufacturing Act of 2018. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. S.3680: Low Drug Prices Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. H.R.6: SUPPORT for Patients and Communities Act.

Client expense: $1,570,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)

S. 92: Safe and Affordable Drugs from Canada Act S. 469: Affordable and Safe Prescription Drug Importation Act S. 1131/ H.R. 2439: FAIR Drug Pricing Act S. 1348: SPIKE Act of 2017 S. 1369/ H.R. 2974: Stop Price Gouging Act S. 1803/H.R. 4825, the Marijuana Effective Drug Studies (MEDS) Act S. 2076/H.R. 4256: BOLD Infrastructure for Alzheimer's Act S. 2406: Advancing Cutting Edge (ACE) Research Act S. 2478: End Taxpayer Subsidies for Drug Ads Act S. 2680: Opioid Crisis Response Act S. 2891: Fighting the Opioid Epidemic with Sunshine Act S. 3369/ HR 6689: Ensuring Lasting Smiles Act S. 3411/H.R. 6689: Affordable Medications Act S. 3657/ H.R. 6615: Traumatic Brain Injury Program Reauthorization Act S. 3686/ H.R. 3580: Protecting Student Athletes from Concussions Act H.R. 6: SUPPORT for Patients and Communities Act: Sections 6062 and 6111; Subtitle E H.R. 1776: Improving Access to Affordable Prescription Drugs Act H.R. 2077: Restoring the Patient's Voice Act H.R. 3391, Medical Marijuana Research Act of 2017 H.R. 4116: Transparent Drug Pricing Act H.R. 5634: Medical Cannabis Research Act H.R. 6340: Capping Prescription Costs Act Disclosure of drug prices in prescription drug direct-to-consumer advertising; Sustained fetal tissue research; Orphan Drug Act Reform; Interoperability, including for Qualified Clinical Data Registries; NIH funding including the BRAIN Initiative; Congressionally-Directed Medical Research Program funding; concussion related issues; loan repayment for pediatric specialists.

Client expense: Not reported · Firm income: $140,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prescription drug pricing. S. 974 - CREATES Act. S. 1131 and H.R. 2439 - Fair Accountability and Innovative Research Drug Pricing Act H.R. 2051 - FAST Generics Act of 2017. Medicare Part D Biosimilars. H.R.6 - SUPPORT for Patients and Communities Act. S. 3120 - HEAL Act of 2018. S. 2553: Know the Lowest Price Act of 2018. S. 2554: Patient Right to Know Drug Prices Act.

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Prescription drug pricing. S. 974 - CREATES Act. S. 1131 and H.R. 2439 - Fair Accountability and Innovative Research Drug Pricing Act H.R. 2051 - FAST Generics Act of 2017 Medicare Part D Biosimilars. H.R.6 - SUPPORT for Patients and Communities Act. S. 2553: Know the Lowest Price Act of 2018. S. 2554: Patient Right to Know Drug Prices Act.

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 2212/ S. 974, CREATES Act - Discussed support of bill. H.R. 2439/S.1131, FAIR Drug Pricing Act - Discussed support of bill. S. 124, The Preserve Access to Affordable Generics Act - Discussed support of bill. Part D Deal in Bipartisan Budget Act, met with House and Senate offices to reiterate our support for the deal; sent multiple letters to House and Senate leadership; discussed support for the deal with House and Senate staff. Discussed the Presidents Prescription Drug Blueprint and RFI. S. 2553, Know the Lowest Price Act - supported passage of legislation. S.2554, Patient Right to Know Act - supported passage of legislation. Discussed possible ways to improve Medicare Part D. Discussed Rx Price Watch Reports and the impact of high drug costs. Discussed drug pricing reforms AARP supports, including secretarial negotiation, importation, reducing exclusivity for biologics, and ending pay-for-delay deals. Discussed Rx issues with HHS.

Client expense: $2,140,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Equal Employment Opportunity Commission (EEOC), Federal Highway Administration (FHA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Highway Traffic Safety Administration (NHTSA), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, White House Office

Prescription drug pricing. S. 974 - CREATES Act. S. 1131 and H.R. 2439 - Fair Accountability and Innovative Research Drug Pricing Act H.R. 2051 - FAST Generics Act of 2017 Medicare Part D Biosimilars. H.R.6 - SUPPORT for Patients and Communities Act. S. 2553: Know the Lowest Price Act of 2018. S. 2554: Patient Right to Know Drug Prices Act.

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Prescription drug pricing. S. 974 - CREATES Act. S. 1131 and H.R. 2439 - Fair Accountability and Innovative Research Drug Pricing Act H.R. 2051 - FAST Generics Act of 2017. Medicare Part D Biosimilars. H.R.6 - SUPPORT for Patients and Communities Act. S. 3120 - HEAL Act of 2018. S. 2553: Know the Lowest Price Act of 2018. S. 2554: Patient Right to Know Drug Prices Act.

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Bipartisan Health Care Stabilization Act, support bipartisan efforts led by Senators Alexander and Murray to stabilize and improve the individual health insurance market while protecting people with chronic conditions. -H.R. 2439/S. 1131, FAIR Drug Pricing Act, support passage. - H.R. 2212/ S. 974, Creating and Restoring Equal Access To Equivalent Samples Act of 2017 (CREATES Act), support passage. -H.R. 2077, Restoring Patients Voice Act, support passage. -S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act, support passage. -H.R. 4841/S. 2908, Standardizing Electronic Prior Authorization for Safe Prescribing Act, support passage. - H.R. 2051, Fair Access for Safe and Timely Generics Act of 2017 (FAST Generics Act), support passage. -H.R. 750, support passage of the Ensuring Access to Quality Complex Rehabilitation Technology Act. -H.R. 1361/S. 486/H.R. 3730, support passage to protect access to complex rehabilitative technology accessories. -H.R. 2535/S. 1188, Lifespan Respite Care Reauthorization Act, support reauthorization of the Lifespan Respite Care Program. -HR 2575/S. 1909, Beneficiary Enrollment Notification and Eligibility Simplification (BENES) Act

Client expense: $59,856 · Firm income: Not reported

Government targets: Army, Dept of (Other), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Preserve Access to Primary Care Services: Address the shortage of primary care physicians; provide scholarships and loan forgiveness in exchange for primary care service commitments to practice in critical shortage areas; provide grants for medical school mentorship programs and primary care training in community health centers; increase Title VII funding for primary care health programs; increase funding for the National Health Service Corps, provide regulatory relief for primary care physicians; H.R. 7192/S. 1174, the Preserving Patient Access to Primary Care Act (as first introduced in the 111th Congress). Support the Affordable Care Act (P.L. 111-148, P.L. 111-152) by: Expanding coverage and improving Medicare benefits; Providing needed protections to guard against insurance practices that unfairly limit, deny or rescind coverage based on health status; public and private health insurers should encourage preventive health care by providing full coverage, with no cost-sharing, for preventive services recommended by an expert advisory group, such as the U.S. Preventive Services Task Force; Ensuring access to primary care physicians; and beginning to bend the cost curve; Prohibiting insurers from excluding or charging excessive rates to children based on pre-existing conditions, which later will be expanded to all persons; Covering young adults on their parents' plans; Eliminating lifetime and annual limits on health insurance coverage; Requiring that health insurers spend more on patient care and less on administration; support enactment of S. 248, the Empowering States to Innovate Act, which amends the Patient Protection and Affordable Care Act (ACA) to: (1) allow states to apply for waivers of certain health insurance coverage requirements in such Act (including requirements for the establishment of qualified health plans and health insurance exchanges) for plan years beginning on or after January 1, 2014 (currently, January 1, 2017), and (2) require the waiver application process to begin not later than 180 days after the enactment of this Act; Phasing out the Medicare Part D doughnut hole; Eliminating patient cost-sharing for preventive services offered by Medicare or private insurers; Increasing Medicare and Medicaid payments to primary care physicians; Supporting the Patient-Centered Outcomes Research Institute to help physicians and patients make care decisions based on the best available evidence; Supporting the Center on Medicare and Medicaid Innovation to fund pilots of delivery models to improve outcomes and reduce costs, including patient-centered medical homes. Improve Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Provide sliding scale subsidies based on income to buy coverage from qualified plans; Qualified plans should: provide evidence-based benefits, including preventive services; and be prohibited from excluding persons with pre-existing conditions, charging them more, cherry-picking enrollees, or cancelling or failing to renew coverage; Expand Medicaid to cover all persons below the Federal Poverty Level and ensure fair payments to participating physicians; As coverage becomes affordable, all persons should participate and coverage should be guaranteed; Responsibility for financing should be shared by individuals, employers and government. Pilot test Medicare payment models that re-align incentives to support effective, efficient, patient-centered, coordinated care. Priority should be given to models designed to support the value of services provided by primary care physicians as well as to models that would create incentives, across physician specialties and sites of services, to improve the quality, effectiveness, and efficiency of care provided. Policy criteria for selecting the most promising models for pilot testing should be developed, in consultation with outside experts; The Patient-Centered Medical Home (PCMH), which has shown great promise in meeting the policy objectives suggested above, should be among the models selected for broader testing on a national pilot basis; the use of the medical home model for treatment or services under private health plans, the requirement of health plans to provide incentives to promote and report on medical home services provided, the establishment of community health teams and a primary care extension program to educate and support primary care practices in the delivery of medical home services, and the establishment of a demonstration project to educate physicians and other clinicians in training in the competencies required to deliver care consistent with the medical home care model. Veterans Care: Regarding the VA Mission Act of 2018 (H.R. 5674), the College urged Congress to ensure that veterans have access to timely, contiguous care across the spectrum of health care services, with coordination and management of that care in the hands of a primary clinician or clinical care team; that the expansion of care to non-VHA facilities does not come at the cost of maintaining or improving existing VHA services or infrastructure; and that recruitment and retention of clinicians to the VHA is valued appropriately, including reimbursement for services provided; Advocated with Congress on the need for adequate funding for the VHA for FY2019 and the long-term. Expand Coverage and Stabilizing the Insurance Market: Congress should work to help stabilize the individual health insurance market and expand coverage. Specifically by develop and introduce comprehensive market stabilization legislation that includes reinsurance options to help stabilize the markets; Expanding cost-sharing assistance eligibility to purchase insurance in the exchanges as well as increase the level of premium tax credits and cost sharing subsidies offered to purchase a qualified health plan; Introducing legislation that would block the expansion of access to short-term health plans or Association Health Plans that allow insurers to charge more to individuals with pre-existing conditions and permit them to exclude from coverage essential medical care; Supporting $690 million in discretionary funding for federal exchanges within CMS Program Operations as part of the FY2019 Labor, Health and Human Services, and Education Appropriations bill. Reduce Unnecessary Administrative Tasks on Physicians and Patients: Congress should accelerate its efforts to reduce administrative burdens on clinicians and patients, including: Passing the Standardizing Electronic Prior Authorization for Safe Prescribing Act (H.R. 4841), which standardizes electronic prior authorization for prescription drugs under Medicare Part D. Adopt even greater harmonization of such standards across the health care industry; Passing the CONNECTIONS Act (H.R. 5812) by Reps. Griffith (R-VA) and Pallone (D-NJ) that would authorize CDC grants to state-run PDMPs to improve data collection and integration into physician clinical workflow specifically, of controlled substances overdose prevention and surveillance activities; Urging health care committees in Congress with jurisdiction over Medicare to exercise their oversight authority of CMS effort to overhaul clinical documentation guidelines with input from practicing clinicians; Passing the Improving Access to Medicare Coverage Act of 2017 (S. 568/H.R. 1421), which deems patients under observation as inpatients for the purposes of satisfying the Medicare 3-day inpatient stay requirement. Health Information Technology (HIT): The College provided feedback on the Centers for Disease Control and Prevention (CDC) Request for Information (RFI) Regarding a National Test Collaborative (NTC), which sought approaches for developing a NTC that would allow for the field testing of health information technology (HIT) in a live clinical setting; expressed concern that building an entirely new testing network will be prohibitively difficult and execution could go wrong unless it is carefully designed, piloted, and tested. Emailing and conference calling with every level of every organization is labor intensive and getting participants engaged in this process will be an enormous effort; urged the need to address the patient privacy issues associated with production settings. These privacy issues may cause concern amongst hospitals and may prevent them from wanting to participate unless addressed; recommended that CDC consider building a CDC-Vendor-End User communication methodology that may be a more manageable undertaking utilizing existing infrastructures. Such a system could allow for CDC to notify EHR vendors who would notify product users when they receive an alert or guidance from CDC, using a process similar to how software updates are released. This approach does not require the sharing of protected health information nor does it require direct access into the production system. Reduce Prescription Drug Costs: Congress should increase transparency and accountability in prescription drug pricing and improve access to lower-cost generic medications by passing the Drug Price Transparency in Communications Act (S. 2157), which would require drug companies to disclose the Wholesale Acquisition Cost of an Rx in Direct-to-Consumer Advertising. Representatives should introduce the companion bill; Passing the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2017 (S. 974/H.R. 2212), which would improve patient access to alternative low-cost prescription drugs and biological products by preventing prescription drug manufacturers from misusing the FDAs Risk Evaluation and Mitigation Strategies (REMS) process to make it difficult for competing generics to be brought to the market; Passing the Medicare Prescription Drug Price Negotiation Act of 2017 (S. 41/H.R. 242), which would grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for high�cost drugs and biologics covered under Part D; Passing the Fair Accountability and Innovative Research (FAIR) Pricing Act (S. 1131/H.R. 2439), which would require drug manufacturers to disclose and provide more information about planned drug price increases, including R&D costs. Fund Workforce, Medical and Health Services Research, Public Health Initiatives: Congress should ensure funding in FY 2019 for federal programs/initiatives designed to support primary care and reject funding rescissions that would harm childrens health coverage or CMS Innovation Center. This includes funding the Primary Care and Training Enhancement (PCTE) at $71 million in order to maintain and expand the pipeline for individuals training in primary care; Funding the National Health Service Corps (NHSC) at least at $415 million in total program funding to fund scholarships and loan repayment to health care professionals to help expand the countrys primary care workforce and meet the health care needs of underserved communities; Funding the Centers for Disease Control and Prevention (CDC) and Prevention and Public Health Fund (PPHF) at $8.45 billion; including PPHF funding at $805 million; Funding the Agency for Healthcare Research and Quality (AHRQ) at $454 million, restoring the agency to its FY2010 enacted level adjusting for inflation after cuts in FY2016 and FY2017 and a small increase in FY2018 so it can help clinicians help patients by making evidence-informed decisions, fund research that serves as the evidence engine for much of the private sectors work to keep patients safe; Funding the National Institutes of Health (NIH) at $39 billion so that this nations biomedical research can continue to fund cures for disease and maintain the U.S. standing as the world leader in medical and biomedical research. Promote Continued Action to Address the Epidemic of Opioid Use: Congress should pass a comprehensive legislative package to improve prevention, education, treatment and recovery for those suffering from opioid-related addictions, including: Providing for sufficient and increased funding to address the opioid epidemic, building and expanding upon the $4.65 billion in the omnibus bill approved by Congress, with at least $1 billion for programs as authorized by CARA 2.0; Expanding access and coverage for medication assisted treatment (methadone, buprenorphine, and naltrexone to prevent opioid and substance use disorders; Rejecting any proposal to impose a three day prescribing limit for initial opioid prescriptions to ensure that doctors have appropriate flexibility to determine the proper duration of each opioid prescription; Passing the Comprehensive Addiction and Recovery Act 2.0 of 2018 (S. 2456/H.R. 5311) as a step toward a more comprehensive opioids-related package. Reduce Firearms-Related Injury and Death: Congress should pass the Assault Weapons Ban of 2018 (S. 2095/H.R. 5077), which would ban the sale of high velocity, rapid file assault rifles and large capacity ammunition magazines and bump stocks; Pass the Brady Background Expansion Act (S. 2009), to expand background checks to virtually all firearm sales in the United States; Pass the Stop Illegal Trafficking in Firearms Act of 2017 (S. 1185), and the Stop Straw Purchases Act (H.R. 5134). Both would increase penalties for individuals who unlawfully purchase firearms for other persons who are prohibited from possessing firearms (known as straw purchasers); Support $50 million in funding for the CDC to conduct such research; Pass S. 834/H.R. 1832 that authorizes funding for the CDC to conduct such research. Make Graduate Medical Education (GME) Funding More Effective: Congress should develop and pass legislation to reform GME to prioritize funding toward physician specialties where millions of patients lack access, including internal medicine specialists trained in comprehensive primary care, to: Increase the number of GME slots by at least 3,000 per year over five years for specialties facing shortages, including internal medicine, as contained in the Resident Physician Shortage Reduction Act of 2017 (S. 1301/H.R. 2267); Combine DGME/IME into a single, more functional program; broaden the GME financing structure to include all payers; Allocate GME funds transparently and to activities that further the educational mission of teaching and training residents/fellows with input from practicing clinicians and in collaboration with their professional organizations; Support continued adequate funding for the VHA and its substantial contributions to the ongoing training of the next generation of physicians. 2019 Physician Fee Schedule (PFS) and Quality Payment Program (QPP): Commented on CMS final rule on the 2019 PFS and QPP including - Urged additional refinements are needed to the final E/M documentation and payment policies to provide for immediate documentation relief, ensure the needs of complex patients are appropriately addressed, and avert negative downstream consequences; supports separate payment for technology-based communication services but urges the Agency to reconsider patient cost sharing and burdensome consent polices which may prevent uptake of these critical services; appreciates the burden relief that will result from allowing physicians to delegate Appropriate Use Criteria (AUC) consultations to appropriate clinical staff, but reiterates need to reimburse clinicians for the additional time required to conduct these consultations and pilot testing AUC in limited clinical priority areas before deploying on a larger scale to prevent widespread payment disruptions. With regard to QPP, urged greater simplifying of MIPS scoring by basing point values for individual measures on their relative value to the total MIPS score, taking every opportunity to award cross category credit, and instituting a consistent minimum 90-day reporting period across all categories; develop more Advanced APMs, particularly for small and specialty practices; opposes the use of cost measures that are deemed unreliable or inaccurate and urges CMS not to increase the weight of the Cost Category until every measure meets rigorous reliability and accuracy standards; reduce overall number of quality measures and use only those deemed valid, relevant, and reliable, such as those recommended by ACPs Performance Measurement Committee. Public Charge: The College provided comments on the Department of Homeland Securitys Notice of Proposed Rulemaking: Inadmissibility on Public Charge Grounds (DHS Docket No. USCIS-2010-0012). ACP oppose the DHS proposed rule on public charge because if finalized it would put the health of millions of children and families at risk. The proposed changes would expand the number of programs that the federal government would consider in public charge determinations to include Medicaid, the Medicare Part D Low-Income Subsidy Program, the Supplemental Nutrition Assistance Program, and potentially the Childrens Health Insurance Program (CHIP), among others. By widening public charge determinations in this way, the proposed rule would make it much more likely that lawfully present immigrants and those seeking to lawfully immigrate to the U.S. could be denied lawful permanent resident status, be denied visas, or even be deported, merely on the basis of seeking essential health, nutrition, and housing services for themselves or their families. The proposed rule would undermine the physician-patient relationship and disrupt care continuity, and it is antithetical to the Colleges mission to ensure meaningful access to health care for our patients. Immigrant Children and Pregnant Women in U.S. Custody: The College commented to the U.S. Department of Homeland Security that conditions in the U.S. Customs and Border Protection (CBP) custody are inconsistent with evidence-based recommendations for appropriate care and treatment of children and pregnant women. As such, they are not appropriate for children or pregnant women. ACP calls for a full, transparent, and public investigation of Jakelin Caal Maquins (from Guatemala) death and the circumstances surrounding it, as well as any other deaths that may have occurred in CBP or Immigration and Customs Enforcement custody. The College strongly urges the Department of Homeland Security (DHS) to implement specific meaningful steps to ensure that all children and pregnant women in CBP custody receive appropriate medical and mental health screening and necessary follow-up care by trained providers.

Client expense: $249,755 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), President of the U.S., SENATE

Preserve Access to Primary Care Services: Address the shortage of primary care physicians; provide scholarships and loan forgiveness in exchange for primary care service commitments to practice in critical shortage areas; provide grants for medical school mentorship programs and primary care training in community health centers; increase Title VII funding for primary care health programs; increase funding for the National Health Service Corps, provide regulatory relief for primary care physicians; H.R. 7192/S. 1174, the Preserving Patient Access to Primary Care Act (as first introduced in the 111th Congress). Support the Affordable Care Act (P.L. 111-148, P.L. 111-152) by: Expanding coverage and improving Medicare benefits; Providing needed protections to guard against insurance practices that unfairly limit, deny or rescind coverage based on health status; public and private health insurers should encourage preventive health care by providing full coverage, with no cost-sharing, for preventive services recommended by an expert advisory group, such as the U.S. Preventive Services Task Force; Ensuring access to primary care physicians; and beginning to bend the cost curve; Prohibiting insurers from excluding or charging excessive rates to children based on pre-existing conditions, which later will be expanded to all persons; Covering young adults on their parents' plans; Eliminating lifetime and annual limits on health insurance coverage; Requiring that health insurers spend more on patient care and less on administration; support enactment of S. 248, the Empowering States to Innovate Act, which amends the Patient Protection and Affordable Care Act (ACA) to: (1) allow states to apply for waivers of certain health insurance coverage requirements in such Act (including requirements for the establishment of qualified health plans and health insurance exchanges) for plan years beginning on or after January 1, 2014 (currently, January 1, 2017), and (2) require the waiver application process to begin not later than 180 days after the enactment of this Act; Phasing out the Medicare Part D doughnut hole; Eliminating patient cost-sharing for preventive services offered by Medicare or private insurers; Increasing Medicare and Medicaid payments to primary care physicians; Supporting the Patient-Centered Outcomes Research Institute to help physicians and patients make care decisions based on the best available evidence; Supporting the Center on Medicare and Medicaid Innovation to fund pilots of delivery models to improve outcomes and reduce costs, including patient-centered medical homes. Improve Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Provide sliding scale subsidies based on income to buy coverage from qualified plans; Qualified plans should: provide evidence-based benefits, including preventive services; and be prohibited from excluding persons with pre-existing conditions, charging them more, cherry-picking enrollees, or cancelling or failing to renew coverage; Expand Medicaid to cover all persons below the Federal Poverty Level and ensure fair payments to participating physicians; As coverage becomes affordable, all persons should participate and coverage should be guaranteed; Responsibility for financing should be shared by individuals, employers and government. Pilot test Medicare payment models that re-align incentives to support effective, efficient, patient-centered, coordinated care. Priority should be given to models designed to support the value of services provided by primary care physicians as well as to models that would create incentives, across physician specialties and sites of services, to improve the quality, effectiveness, and efficiency of care provided. Policy criteria for selecting the most promising models for pilot testing should be developed, in consultation with outside experts; The Patient-Centered Medical Home (PCMH), which has shown great promise in meeting the policy objectives suggested above, should be among the models selected for broader testing on a national pilot basis; the use of the medical home model for treatment or services under private health plans, the requirement of health plans to provide incentives to promote and report on medical home services provided, the establishment of community health teams and a primary care extension program to educate and support primary care practices in the delivery of medical home services, and the establishment of a demonstration project to educate physicians and other clinicians in training in the competencies required to deliver care consistent with the medical home care model. Veterans Care: Regarding the VA Mission Act of 2018 (H.R. 5674), the College urged Congress to ensure that veterans have access to timely, contiguous care across the spectrum of health care services, with coordination and management of that care in the hands of a primary clinician or clinical care team; that the expansion of care to non-VHA facilities does not come at the cost of maintaining or improving existing VHA services or infrastructure; and that recruitment and retention of clinicians to the VHA is valued appropriately, including reimbursement for services provided; Advocated with Congress on the need for adequate funding for the VHA for FY2019 and the long-term. Expand Coverage and Stabilizing the Insurance Market: Congress should work to help stabilize the individual health insurance market and expand coverage. Specifically by develop and introduce comprehensive market stabilization legislation that includes reinsurance options to help stabilize the markets; Expanding cost-sharing assistance eligibility to purchase insurance in the exchanges as well as increase the level of premium tax credits and cost sharing subsidies offered to purchase a qualified health plan; Introducing legislation that would block the expansion of access to short-term health plans or Association Health Plans that allow insurers to charge more to individuals with pre-existing conditions and permit them to exclude from coverage essential medical care; Supporting $690 million in discretionary funding for federal exchanges within CMS Program Operations as part of the FY2019 Labor, Health and Human Services, and Education Appropriations bill. Reduce Unnecessary Administrative Tasks on Physicians and Patients: Congress should accelerate its efforts to reduce administrative burdens on clinicians and patients, including: Passing the Standardizing Electronic Prior Authorization for Safe Prescribing Act (H.R. 4841), which standardizes electronic prior authorization for prescription drugs under Medicare Part D. Adopt even greater harmonization of such standards across the health care industry; Passing the CONNECTIONS Act (H.R. 5812) by Reps. Griffith (R-VA) and Pallone (D-NJ) that would authorize CDC grants to state-run PDMPs to improve data collection and integration into physician clinical workflow specifically, of controlled substances overdose prevention and surveillance activities; Urging health care committees in Congress with jurisdiction over Medicare to exercise their oversight authority of CMS effort to overhaul clinical documentation guidelines with input from practicing clinicians; Passing the Improving Access to Medicare Coverage Act of 2017 (S. 568/H.R. 1421), which deems patients under observation as inpatients for the purposes of satisfying the Medicare 3-day inpatient stay requirement. Health Information Technology (HIT): The College provided feedback on the Centers for Disease Control and Prevention (CDC) Request for Information (RFI) Regarding a National Test Collaborative (NTC), which sought approaches for developing a NTC that would allow for the field testing of health information technology (HIT) in a live clinical setting; expressed concern that building an entirely new testing network will be prohibitively difficult and execution could go wrong unless it is carefully designed, piloted, and tested. Emailing and conference calling with every level of every organization is labor intensive and getting participants engaged in this process will be an enormous effort; urged the need to address the patient privacy issues associated with production settings. These privacy issues may cause concern amongst hospitals and may prevent them from wanting to participate unless addressed; recommended that CDC consider building a CDC-Vendor-End User communication methodology that may be a more manageable undertaking utilizing existing infrastructures. Such a system could allow for CDC to notify EHR vendors who would notify product users when they receive an alert or guidance from CDC, using a process similar to how software updates are released. This approach does not require the sharing of protected health information nor does it require direct access into the production system. Reduce Prescription Drug Costs: Congress should increase transparency and accountability in prescription drug pricing and improve access to lower-cost generic medications by passing the Drug Price Transparency in Communications Act (S. 2157), which would require drug companies to disclose the Wholesale Acquisition Cost of an Rx in Direct-to-Consumer Advertising. Representatives should introduce the companion bill; Passing the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2017 (S. 974/H.R. 2212), which would improve patient access to alternative low-cost prescription drugs and biological products by preventing prescription drug manufacturers from misusing the FDAs Risk Evaluation and Mitigation Strategies (REMS) process to make it difficult for competing generics to be brought to the market; Passing the Medicare Prescription Drug Price Negotiation Act of 2017 (S. 41/H.R. 242), which would grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for high�cost drugs and biologics covered under Part D; Passing the Fair Accountability and Innovative Research (FAIR) Pricing Act (S. 1131/H.R. 2439), which would require drug manufacturers to disclose and provide more information about planned drug price increases, including R&D costs. Fund Workforce, Medical and Health Services Research, Public Health Initiatives: Congress should ensure funding in FY 2019 for federal programs/initiatives designed to support primary care and reject funding rescissions that would harm childrens health coverage or CMS Innovation Center. This includes funding the Primary Care and Training Enhancement (PCTE) at $71 million in order to maintain and expand the pipeline for individuals training in primary care; Funding the National Health Service Corps (NHSC) at least at $415 million in total program funding to fund scholarships and loan repayment to health care professionals to help expand the countrys primary care workforce and meet the health care needs of underserved communities; Funding the Centers for Disease Control and Prevention (CDC) and Prevention and Public Health Fund (PPHF) at $8.45 billion; including PPHF funding at $805 million; Funding the Agency for Healthcare Research and Quality (AHRQ) at $454 million, restoring the agency to its FY2010 enacted level adjusting for inflation after cuts in FY2016 and FY2017 and a small increase in FY2018 so it can help clinicians help patients by making evidence-informed decisions, fund research that serves as the evidence engine for much of the private sectors work to keep patients safe; Funding the National Institutes of Health (NIH) at $39 billion so that this nations biomedical research can continue to fund cures for disease and maintain the U.S. standing as the world leader in medical and biomedical research. Promote Continued Action to Address the Epidemic of Opioid Use: Congress should pass a comprehensive legislative package to improve prevention, education, treatment and recovery for those suffering from opioid-related addictions, including: Providing for sufficient and increased funding to address the opioid epidemic, building and expanding upon the $4.65 billion in the omnibus bill approved by Congress, with at least $1 billion for programs as authorized by CARA 2.0; Expanding access and coverage for medication assisted treatment (methadone, buprenorphine, and naltrexone to prevent opioid and substance use disorders; Rejecting any proposal to impose a three day prescribing limit for initial opioid prescriptions to ensure that doctors have appropriate flexibility to determine the proper duration of each opioid prescription; Passing the Comprehensive Addiction and Recovery Act 2.0 of 2018 (S. 2456/H.R. 5311) as a step toward a more comprehensive opioids-related package. Reduce Firearms-Related Injury and Death: Congress should pass the Assault Weapons Ban of 2018 (S. 2095/H.R. 5077), which would ban the sale of high velocity, rapid file assault rifles and large capacity ammunition magazines and bump stocks; Pass the Brady Background Expansion Act (S. 2009), to expand background checks to virtually all firearm sales in the United States; Pass the Stop Illegal Trafficking in Firearms Act of 2017 (S. 1185), and the Stop Straw Purchases Act (H.R. 5134). Both would increase penalties for individuals who unlawfully purchase firearms for other persons who are prohibited from possessing firearms (known as straw purchasers); Support $50 million in funding for the CDC to conduct such research; Pass S. 834/H.R. 1832 that authorizes funding for the CDC to conduct such research. Make Graduate Medical Education (GME) Funding More Effective: Congress should develop and pass legislation to reform GME to prioritize funding toward physician specialties where millions of patients lack access, including internal medicine specialists trained in comprehensive primary care, to: Increase the number of GME slots by at least 3,000 per year over five years for specialties facing shortages, including internal medicine, as contained in the Resident Physician Shortage Reduction Act of 2017 (S. 1301/H.R. 2267); Combine DGME/IME into a single, more functional program; broaden the GME financing structure to include all payers; Allocate GME funds transparently and to activities that further the educational mission of teaching and training residents/fellows with input from practicing clinicians and in collaboration with their professional organizations; Support continued adequate funding for the VHA and its substantial contributions to the ongoing training of the next generation of physicians. 2019 Physician Fee Schedule (PFS) and Quality Payment Program (QPP): Commented on CMS final rule on the 2019 PFS and QPP including - Urged additional refinements are needed to the final E/M documentation and payment policies to provide for immediate documentation relief, ensure the needs of complex patients are appropriately addressed, and avert negative downstream consequences; supports separate payment for technology-based communication services but urges the Agency to reconsider patient cost sharing and burdensome consent polices which may prevent uptake of these critical services; appreciates the burden relief that will result from allowing physicians to delegate Appropriate Use Criteria (AUC) consultations to appropriate clinical staff, but reiterates need to reimburse clinicians for the additional time required to conduct these consultations and pilot testing AUC in limited clinical priority areas before deploying on a larger scale to prevent widespread payment disruptions. With regard to QPP, urged greater simplifying of MIPS scoring by basing point values for individual measures on their relative value to the total MIPS score, taking every opportunity to award cross category credit, and instituting a consistent minimum 90-day reporting period across all categories; develop more Advanced APMs, particularly for small and specialty practices; opposes the use of cost measures that are deemed unreliable or inaccurate and urges CMS not to increase the weight of the Cost Category until every measure meets rigorous reliability and accuracy standards; reduce overall number of quality measures and use only those deemed valid, relevant, and reliable, such as those recommended by ACPs Performance Measurement Committee. Public Charge: The College provided comments on the Department of Homeland Securitys Notice of Proposed Rulemaking: Inadmissibility on Public Charge Grounds (DHS Docket No. USCIS-2010-0012). ACP oppose the DHS proposed rule on public charge because if finalized it would put the health of millions of children and families at risk. The proposed changes would expand the number of programs that the federal government would consider in public charge determinations to include Medicaid, the Medicare Part D Low-Income Subsidy Program, the Supplemental Nutrition Assistance Program, and potentially the Childrens Health Insurance Program (CHIP), among others. By widening public charge determinations in this way, the proposed rule would make it much more likely that lawfully present immigrants and those seeking to lawfully immigrate to the U.S. could be denied lawful permanent resident status, be denied visas, or even be deported, merely on the basis of seeking essential health, nutrition, and housing services for themselves or their families. The proposed rule would undermine the physician-patient relationship and disrupt care continuity, and it is antithetical to the Colleges mission to ensure meaningful access to health care for our patients. Immigrant Children and Pregnant Women in U.S. Custody: The College commented to the U.S. Department of Homeland Security that conditions in the U.S. Customs and Border Protection (CBP) custody are inconsistent with evidence-based recommendations for appropriate care and treatment of children and pregnant women. As such, they are not appropriate for children or pregnant women. ACP calls for a full, transparent, and public investigation of Jakelin Caal Maquins (from Guatemala) death and the circumstances surrounding it, as well as any other deaths that may have occurred in CBP or Immigration and Customs Enforcement custody. The College strongly urges the Department of Homeland Security (DHS) to implement specific meaningful steps to ensure that all children and pregnant women in CBP custody receive appropriate medical and mental health screening and necessary follow-up care by trained providers.

Client expense: $92,631 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), President of the U.S., SENATE

H.R.1776/ S.771, Improving Access To Affordable Prescription Drugs Act H.R. 2439/ S.1131, Fair Accountability and Innovative Research Drug Pricing Act S.1348, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act H.R.4385, Responsibility in Drug Advertising Act H.R.4116, Transparent Drug Pricing Act S.2157, Drug-Price Transparency in Communications Act S.2478, End Taxpayer Subsidies for Drug Ads Act FTC Reauthorization Act of 2018 (Not introduced)

Client expense: Not reported · Firm income: $90,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. S.3519: MODERN Labeling Act. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. H.R.6577: PRICED Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, Packaging and Disposal. H.R.6: SUPPORT for Patients and Communities Act.

Client expense: $870,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, FDA Accelerated Approval and Breakthrough Therapy Status. Discussion Draft of H.R.__, FDA and International Mail. Discussion Draft of H.R.__, Opioid Sparing. Discussion Draft of H.R.__, Packaging and Disposal. Discussion Draft of H.R.__, Long-term Efficiency. Discussion Draft of H.R.__, Misuse/Abuse.

Client expense: $900,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)

Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. Opioid abuse. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1892: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. H.R.2430/S.934: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, FDA Accelerated Approval and Breakthrough Therapy Status. Discussion Draft of H.R.__, FDA and International Mail. Discussion Draft of H.R.__, Opioid Sparing. Discussion Draft of H.R.__, Packaging and Disposal. Discussion Draft of H.R.__, Long-term Efficiency. Discussion Draft of H.R.__, Misuse/Abuse.

Client expense: $1,040,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. S.3519: MODERN Labeling Act. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. H.R.6577: PRICED Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, Packaging and Disposal. H.R.6: SUPPORT for Patients and Communities Act.

Client expense: $860,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)

Issues related to S.2315 "Over-the-Counter Drug Safety, Innovation, and Reform Act; general issues related to drug pricing;issues related to cosmetic regulations; issues related to insulin pricing;issues related H.R. 6378 "Pandemic and All Hazards Preparedness (PAHPA)Advancing Innovation Act"; issues related to Medicare Part D; issues related to flu and Veterans Affairs; issues related to seasonal influenza vaccination; issues related to 340B Reform; issues related to Drug Importation; issues related to vaccine safety;issues related to HR5333 "Over-the-Counter Monograph Safety, Innovation, and reform Act of 2018; issues related to HR2212 "CREATES Act of 2017";issues related to HR 2439 "Fair Accountability and Innovation Research Drug Act of 2017"; issues related to Medicare rebate disclosure; issues related to S. 2852 "Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018"; issues related to S. 297 "Increasing Competition in Pharmaceuticals Act"; and issues related to S.2465 "Sickle Cell Disease and other Heritable Blood Disorders Research, Surveillance, Prevention and Treatment Act of 2018"

Client expense: $760,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 92: Safe and Affordable Drugs from Canada Act S. 469: Affordable and Safe Prescription Drug Importation Act S. 1131/ H.R. 2439: FAIR Drug Pricing Act S. 1348: SPIKE Act of 2017 S. 1369/ H.R. 2974: Stop Price Gouging Act S. 2260 / H.R. 4733: Opioids and STOP Pain Initiative Act S. 2406: Advancing Cutting Edge (ACE) Research Act S. 2478: End Taxpayer Subsidies for Drug Ads Act S. 2680: Opioid Crisis Response Act S. 2891: Fighting the Opioid Epidemic with Sunshine Act S. 3369/ H.R. 6689: Ensuring Lasting Smiles Act S. 3411: Affordable Medications Act H.R. 6: SUPPORT for Patients and Communities Act: Sections 6062 and 6111; Subtitle E H.R. 1776: Improving Access to Affordable Prescription Drugs Act H.R. 2077: Restoring the Patient's Voice Act H.R. 4116: Transparent Drug Pricing Act H.R. 5634: Medical Cannabis Research Act H.R. 6340: Capping Prescription Costs Act Interoperability, including for Qualified Clinical Data Registries; Appropriations for the CDC National Neurological Conditions Surveillance System; Maintenance/expansion of Graduate Medical Education (GME); NIH funding including the BRAIN Initiative; Congressionally-Directed Medical Research Program funding; concussion related issues.

Client expense: Not reported · Firm income: $250,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 297, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug costs S. 974, CREATES Act (Leahy-Grassley) - access to generic drugs and biosimilars S. 1115, Making Pharmaceutical Markets More Competitive Act (Collins-McCaskill) - accelerated approval of generic therapies S. 1131, FAIR Drug Pricing Act (Baldwin-McCain) - transparency in prescription drug pricing S. 2553, Know the Lowest Price Act (Stabenow) - pharmacist-patient communications, S. 2554, Patient Right to Know Drug Prices Act (Collins) - pharmacist-patient communications, reporting of biosimilar pay-for-delay settlements S. 3194, Capping Prescription Costs Act (Warren) - capping prescription copays H.R. 749, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug costs H.R. 1703, Medical Product Communication Act (Griffith) - off-label exchange of information H.R. 2026, Pharmaceutical Information Exchange Act (Guthrie) - pre-approval health care economic information to payors H.R. 2051, Fair Access for Safe and Timely Generics Act (McKinley-Welch) - access to generic drugs H.R. 2212, CREATES Act (Marino-Cicilline) - access to generic drugs and biosimilars H.R. 2439, FAIR Drug Pricing Act (Schakowsky) - transparency in prescription drug pricing H.R. 2562, Making Pharmaceutical Markets More Competitive Act (Kelly) - accelerated approval of generic therapies H.R. 2999, Patients' Access to Treatments Act (McKinley) - limiting cost sharing in specialty drug tiers H.R. 5247, Right to Try Act (Fitzpatrick) - use of unapproved investigational drugs by patients with life-threatening conditions H.R. 6142, Reducing Drug Waste Act (Doggett) - packaging of medications H.R. 6157, Defense-Labor-HHS-Education Appropriations Act (Granger) -pharmaceutical price transparency in DTC advertising H.R. 6340, Capping Prescription Costs Act (Rosen) - capping prescription copays H.R. 6478, Biosimilars Competition Act (Sarbanes) - reporting of pay-for-delay settlements H.R. 6576, Drug-Price Transparency in Communications Act (Schakowsky) - disclosure of drug prices in DTC advertising H.R. 6733, Know the Cost Act (Carter) - pharmacist-patient communications 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; issues relating to opioids; issues relating to prescription drug price blueprint; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Client expense: $1,500,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of

S. 297, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug costs S. 974, CREATES Act (Leahy-Grassley) - access to generic drugs and biosimilars S. 1115, Making Pharmaceutical Markets More Competitive Act (Collins-McCaskill) - accelerated approval of generic therapies S. 1131, FAIR Drug Pricing Act (Baldwin-McCain) - transparency in prescription drug pricing S. 2553, Know the Lowest Price Act (Stabenow) - information on drug prices S. 2554, Patient Right to Know Drug Prices Act (Collins) - information on drug prices H.R. 749, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug costs H.R. 1703, Medical Product Communication Act (Griffith) - off-label exchange of information H.R. 2026, Pharmaceutical Information Exchange Act (Guthrie) - pre-approval health care economic information to payors H.R. 2051, Fair Access for Safe and Timely Generics Act (McKinley-Welch) - access to generic drugs H.R. 2212, CREATES Act (Marino-Cicilline) - access to generic drugs and biosimilars H.R. 2439, FAIR Drug Pricing Act (Schakowsky) - transparency in prescription drug pricing H.R. 2562, Making Pharmaceutical Markets More Competitive Act (Kelly) - accelerated approval of generic therapies H.R. 2999, Patients' Access to Treatments Act (McKinley) - limiting cost sharing in specialty drug tiers H.R. 5247, Right to Try Act (Fitzpatrick) - use of unapproved investigational drugs by patients with life-threatening conditions H.R. 6142, Reducing Drug Waste Act (Doggett) - packaging of medications 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; issues relating to opioids; issues relating to prescription drug price blueprint; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Client expense: $1,410,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

-Bipartisan Health Care Stabilization Act, support bipartisan efforts led by Senators Alexander and Murray to stabilize and improve the individual health insurance market while protecting people with chronic conditions. -H.R. 2439/S. 1131, FAIR Drug Pricing Act, support passage. - H.R. 2212/ S. 974, Creating and Restoring Equal Access To Equivalent Samples Act of 2017 (CREATES Act), support passage. -H.R. 2077, Restoring Patients Voice Act, support passage. -S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act, support passage. -H.R. 4841/S. 2908, Standardizing Electronic Prior Authorization for Safe Prescribing Act, support passage. - H.R. 2051, Fair Access for Safe and Timely Generics Act of 2017 (FAST Generics Act), support passage. -H.R. 750, support passage of the Ensuring Access to Quality Complex Rehabilitation Technology Act. -H.R. 1361/S. 486/H.R. 3730, support passage to protect access to complex rehabilitative technology accessories. -H.R. 2535/S. 1188, Lifespan Respite Care Reauthorization Act, support reauthorization of the Lifespan Respite Care Program. -HR 2575/S. 1909, Beneficiary Enrollment Notification and Eligibility Simplification (BENES) Act

Client expense: $105,700 · Firm income: Not reported

Government targets: Army, Dept of (Other), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Prescription drug pricing. S. 974 - CREATES Act. S. 1131 and H.R. 2439 - Fair Accountability and Innovative Research Drug Pricing Act H.R. 2051 - FAST Generics Act of 2017 Medicare Part D Biosimilars. H.R.6 - SUPPORT for Patients and Communities Act. S. 2553: Know the Lowest Price Act of 2018. S. 2554: Patient Right to Know Drug Prices Act.

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Prescription drug pricing. S. 974 - CREATES Act. S. 1131 and H.R. 2439 - Fair Accountability and Innovative Research Drug Pricing Act H.R. 2051 - FAST Generics Act of 2017. Medicare Part D Biosimilars. H.R.6 - SUPPORT for Patients and Communities Act. S. 3120 - HEAL Act of 2018. S. 2553: Know the Lowest Price Act of 2018. S. 2554: Patient Right to Know Drug Prices Act.

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Prescription drug pricing. S. 974 - CREATES Act. S. 1131 and H.R. 2439 - Fair Accountability and Innovative Research Drug Pricing Act H.R. 2051 - FAST Generics Act of 2017 Medicare Part D Biosimilars. H.R.6 - SUPPORT for Patients and Communities Act. S. 2553: Know the Lowest Price Act of 2018. S. 2554: Patient Right to Know Drug Prices Act.

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Prescription drug pricing. S. 974 - CREATES Act. S. 1131 and H.R. 2439 - Fair Accountability and Innovative Research Drug Pricing Act H.R. 2051 - FAST Generics Act of 2017. Medicare Part D Biosimilars. H.R.6 - SUPPORT for Patients and Communities Act. S. 3120 - HEAL Act of 2018. S. 2553: Know the Lowest Price Act of 2018. S. 2554: Patient Right to Know Drug Prices Act.

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Preserve Access to Primary Care Services: Address the shortage of primary care physicians; provide scholarships and loan forgiveness in exchange for primary care service commitments to practice in critical shortage areas; provide grants for medical school mentorship programs and primary care training in community health centers; increase Title VII funding for primary care health programs; increase funding for the National Health Service Corps, provide regulatory relief for primary care physicians; H.R. 7192/S. 1174, the Preserving Patient Access to Primary Care Act (as first introduced in the 111th Congress). Support the Affordable Care Act (P.L. 111-148, P.L. 111-152) by: Expanding coverage and improving Medicare benefits; Providing needed protections to guard against insurance practices that unfairly limit, deny or rescind coverage based on health status; public and private health insurers should encourage preventive health care by providing full coverage, with no cost-sharing, for preventive services recommended by an expert advisory group, such as the U.S. Preventive Services Task Force; Ensuring access to primary care physicians; and beginning to bend the cost curve; Prohibiting insurers from excluding or charging excessive rates to children based on pre-existing conditions, which later will be expanded to all persons; Covering young adults on their parents' plans; Eliminating lifetime and annual limits on health insurance coverage; Requiring that health insurers spend more on patient care and less on administration; support enactment of S. 248, the Empowering States to Innovate Act, which amends the Patient Protection and Affordable Care Act (ACA) to: (1) allow states to apply for waivers of certain health insurance coverage requirements in such Act (including requirements for the establishment of qualified health plans and health insurance exchanges) for plan years beginning on or after January 1, 2014 (currently, January 1, 2017), and (2) require the waiver application process to begin not later than 180 days after the enactment of this Act; Phasing out the Medicare Part D doughnut hole; Eliminating patient cost-sharing for preventive services offered by Medicare or private insurers; Increasing Medicare and Medicaid payments to primary care physicians; Supporting the Patient-Centered Outcomes Research Institute to help physicians and patients make care decisions based on the best available evidence; Supporting the Center on Medicare and Medicaid Innovation to fund pilots of delivery models to improve outcomes and reduce costs, including patient-centered medical homes. Medicare Physician Payment Reform: Advocated in support of H.R. 2, the Medicare Access and CHIP Reauthorization Act (MACRA), which was enacted in April 2015 and repealed Medicares Sustainable Growth Rate (SGR) formula and moved us to a new value-based payment and delivery system under Medicare; Advocated with CMS on numerous aspects of the MACRA proposed and final rules, including: proposing a distinctive alternative scoring methodology, developed by ACP, which combines, simplifies, aligns and reduces the complexity of the four reporting categories that will qualify physicians for FFS payment adjustments; proposing specific alternatives to CMS Advancing Care Information program that replaced the Meaningful Use program; proposing additional improvements to simplify the reporting requirements for the Quality, Advancing Care Information and Improvement Activities categories; urging CMS to immediately create virtual reporting options and to create safe harbors for smaller practices until such options are available; proposing more options and flexibility, instead of a one-size fits all approach, for practices to be certified as Patient-Centered Medical Homes or Patient-Centered Medical Home specialty practices, qualifying them for the highest possible score for the Clinical Practice Improvement Activity reporting category; Proposing four different options for Medical Home practices to qualify as advanced Alternative Payment Models, instead of the single option proposed by CMS, including options to allow PCMHs to qualify without taking financial risk: Advocated with CMS on Patient Relationship Categories and Codes, as required by MACRA, specifically: that CMS work to ensure that patients, families, and the relationship of patients and families with their physicians are at the forefront of the Agencys thinking in the development of both the Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) pathways; that the implementation of these categories and codes is carried out in a manner that fully considers and minimizes the impact of reporting burden on the participating clinicians and that has appropriate flexibility to allow for learning and improvement in the approach by both the Agency and the clinicians. Improve Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Provide sliding scale subsidies based on income to buy coverage from qualified plans; Qualified plans should: provide evidence-based benefits, including preventive services; and be prohibited from excluding persons with pre-existing conditions, charging them more, cherry-picking enrollees, or cancelling or failing to renew coverage; Expand Medicaid to cover all persons below the Federal Poverty Level and ensure fair payments to participating physicians; As coverage becomes affordable, all persons should participate and coverage should be guaranteed; Responsibility for financing should be shared by individuals, employers and government. The College believes that strong oversight is needed when determining the initial benchmark plan (and whether it reflects the coverage requirements of the Affordable Care Act) and how the package will be updated, particularly if insurers are given the ability to substitute benefits within and across categories. State and the federal government must work in concert with physicians, health care providers and payers to determine and promote use of clinically effective and cost-effective services that result in improved patient health while bending the cost curve. Under the Affordable Care Act, advocated to ensure that people residing in states with health insurance marketplaces operated by the federal government do not lose their cost-sharing reduction subsidies (CSRs) and that those CSRs should be continued indefinitely as part of a larger bipartisan effort to stabilize the individual insurance market. Pilot test Medicare payment models that re-align incentives to support effective, efficient, patient-centered, coordinated care. Priority should be given to models designed to support the value of services provided by primary care physicians as well as to models that would create incentives, across physician specialties and sites of services, to improve the quality, effectiveness, and efficiency of care provided. Policy criteria for selecting the most promising models for pilot testing should be developed, in consultation with outside experts; The Patient-Centered Medical Home (PCMH), which has shown great promise in meeting the policy objectives suggested above, should be among the models selected for broader testing on a national pilot basis; the use of the medical home model for treatment or services under private health plans, the requirement of health plans to provide incentives to promote and report on medical home services provided, the establishment of community health teams and a primary care extension program to educate and support primary care practices in the delivery of medical home services, and the establishment of a demonstration project to educate physicians and other clinicians in training in the competencies required to deliver care consistent with the medical home care model. Veterans Care: Regarding the VA Mission Act of 2018 (H.R. 5674), the College urged Congress to ensure that veterans have access to timely, contiguous care across the spectrum of health care services, with coordination and management of that care in the hands of a primary clinician or clinical care team; that the expansion of care to non-VHA facilities does not come at the cost of maintaining or improving existing VHA services or infrastructure; and that recruitment and retention of clinicians to the VHA is valued appropriately, including reimbursement for services provided; Advocated with Congress on the need for adequate funding for the VHA for FY2019 and the long-term. Immigration: Voiced support to Congress on the need to pass the Development, Relief, and Education for Alien Minors (DREAM) Act of 2017, H.R. 3440. This legislation would establish a three-step pathway to U.S. citizenship through college, work, or the armed services for individuals who were born in another country and brought illegally to the U.S. at a young age (DREAMers). Clinical Labs: Commented to the Centers for Medicare and Medicaid Services (CMS) on issues pertaining to the Protecting Access to Medicare Act of 2014 (PAMA), specifically citing concerns about the potential impacts of PAMA on patient access to critical rapid clinical testing services offered to patients while they are receiving medical care in their physicians office; expressed further concerns about impending cuts on Jan. 1, 2018 for physician office-based testing services. Expand Coverage and Stabilizing the Insurance Market: Congress should work to help stabilize the individual health insurance market and expand coverage. Specifically by develop and introduce comprehensive market stabilization legislation that includes reinsurance options to help stabilize the markets; Expanding cost-sharing assistance eligibility to purchase insurance in the exchanges as well as increase the level of premium tax credits and cost sharing subsidies offered to purchase a qualified health plan; Introducing legislation that would block the expansion of access to short-term health plans or Association Health Plans that allow insurers to charge more to individuals with pre-existing conditions and permit them to exclude from coverage essential medical care; Supporting $690 million in discretionary funding for federal exchanges within CMS Program Operations as part of the FY2019 Labor, Health and Human Services, and Education Appropriations bill. Reduce Unnecessary Administrative Tasks on Physicians and Patients: Congress should accelerate its efforts to reduce administrative burdens on clinicians and patients, including: Passing the Standardizing Electronic Prior Authorization for Safe Prescribing Act (H.R. 4841), which standardizes electronic prior authorization for prescription drugs under Medicare Part D. Adopt even greater harmonization of such standards across the health care industry; Passing the CONNECTIONS Act (H.R. 5812) by Reps. Griffith (R-VA) and Pallone (D-NJ) that would authorize CDC grants to state-run PDMPs to improve data collection and integration into physician clinical workflow specifically, of controlled substances overdose prevention and surveillance activities; Urging health care committees in Congress with jurisdiction over Medicare to exercise their oversight authority of CMS effort to overhaul clinical documentation guidelines with input from practicing clinicians; Passing the Improving Access to Medicare Coverage Act of 2017 (S. 568/H.R. 1421), which deems patients under observation as inpatients for the purposes of satisfying the Medicare 3-day inpatient stay requirement. Reduce Prescription Drug Costs: Congress should increase transparency and accountability in prescription drug pricing and improve access to lower-cost generic medications by passing the Drug Price Transparency in Communications Act (S. 2157), which would require drug companies to disclose the Wholesale Acquisition Cost of an Rx in Direct-to-Consumer Advertising. Representatives should introduce the companion bill; Passing the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2017 (S. 974/H.R. 2212), which would improve patient access to alternative low-cost prescription drugs and biological products by preventing prescription drug manufacturers from misusing the FDAs Risk Evaluation and Mitigation Strategies (REMS) process to make it difficult for competing generics to be brought to the market; Passing the Medicare Prescription Drug Price Negotiation Act of 2017 (S. 41/H.R. 242), which would grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for high�cost drugs and biologics covered under Part D; Passing the Fair Accountability and Innovative Research (FAIR) Pricing Act (S. 1131/H.R. 2439), which would require drug manufacturers to disclose and provide more information about planned drug price increases, including R&D costs. Fund Workforce, Medical and Health Services Research, Public Health Initiatives: Congress should ensure funding in FY 2019 for federal programs/initiatives designed to support primary care and reject funding rescissions that would harm childrens health coverage or CMS Innovation Center. This includes funding the Primary Care and Training Enhancement (PCTE) at $71 million in order to maintain and expand the pipeline for individuals training in primary care; Funding the National Health Service Corps (NHSC) at least at $415 million in total program funding to fund scholarships and loan repayment to health care professionals to help expand the countrys primary care workforce and meet the health care needs of underserved communities; Funding the Centers for Disease Control and Prevention (CDC) and Prevention and Public Health Fund (PPHF) at $8.45 billion; including PPHF funding at $805 million; Funding the Agency for Healthcare Research and Quality (AHRQ) at $454 million, restoring the agency to its FY2010 enacted level adjusting for inflation after cuts in FY2016 and FY2017 and a small increase in FY2018 so it can help clinicians help patients by making evidence-informed decisions, fund research that serves as the evidence engine for much of the private sectors work to keep patients safe; Funding the National Institutes of Health (NIH) at $39 billion so that this nations biomedical research can continue to fund cures for disease and maintain the U.S. standing as the world leader in medical and biomedical research. Promote Continued Action to Address the Epidemic of Opioid Use: Congress should pass a comprehensive legislative package to improve prevention, education, treatment and recovery for those suffering from opioid-related addictions, including: Providing for sufficient and increased funding to address the opioid epidemic, building and expanding upon the $4.65 billion in the omnibus bill approved by Congress, with at least $1 billion for programs as authorized by CARA 2.0; Expanding access and coverage for medication assisted treatment (methadone, buprenorphine, and naltrexone to prevent opioid and substance use disorders; Rejecting any proposal to impose a three day prescribing limit for initial opioid prescriptions to ensure that doctors have appropriate flexibility to determine the proper duration of each opioid prescription; Passing the Comprehensive Addiction and Recovery Act 2.0 of 2018 (S. 2456/H.R. 5311) as a step toward a more comprehensive opioids-related package. Reduce Firearms-Related Injury and Death: Congress should pass the Assault Weapons Ban of 2018 (S. 2095/H.R. 5077), which would ban the sale of high velocity, rapid file assault rifles and large capacity ammunition magazines and bump stocks; Pass the Brady Background Expansion Act (S. 2009), to expand background checks to virtually all firearm sales in the United States; Pass the Stop Illegal Trafficking in Firearms Act of 2017 (S. 1185), and the Stop Straw Purchases Act (H.R. 5134). Both would increase penalties for individuals who unlawfully purchase firearms for other persons who are prohibited from possessing firearms (known as straw purchasers); Repeal the Dickey amendment restricting firearms-related research by federal agencies and support $50 million in funding for the CDC to conduct such research; Pass S. 834/H.R. 1832 that authorizes funding for the CDC to conduct such research. Make Graduate Medical Education (GME) Funding More Effective: Congress should develop and pass legislation to reform GME to prioritize funding toward physician specialties where millions of patients lack access, including internal medicine specialists trained in comprehensive primary care, to: Increase the number of GME slots by at least 3,000 per year over five years for specialties facing shortages, including internal medicine, as contained in the Resident Physician Shortage Reduction Act of 2017 (S. 1301/H.R. 2267); Combine DGME/IME into a single, more functional program; broaden the GME financing structure to include all payers; Allocate GME funds transparently and to activities that further the educational mission of teaching and training residents/fellows with input from practicing clinicians and in collaboration with their professional organizations; Support continued adequate funding for the VHA and its substantial contributions to the ongoing training of the next generation of physicians. Title X Regulations: Commented to HHS in July on the proposed rule to revise Title X regulations (Title X of the Public Health Service Act) to ensure compliance with, and enhance implementation of, the statutory requirement that none of the funds appropriated for Title X may be used in programs where pregnancy termination is a method of family planning and related statutory requirements. The College asserts that women should have sufficient access to evidence-based family planning and sexual health information and the full range of medically accepted forms of contraception. The College opposes government restrictions that would erode or abrogate a woman's right to continue or discontinue a pregnancy. The College opposes any legislation or regulations that limit access to comprehensive reproductive health care by putting medically unnecessary restrictions on health care professionals or facilities. Kentucky Health Waiver: The College commented to CMS on Kentuckys Health Waiver expressing concern that: it would impose a substantial monthly premium on Medicaid beneficiaries; would also create a six-month lock-out period for certain enrollees who do not pay their premiums on time, which is unduly harsh; that proposed work requirements will impose an unnecessary and unjustified burden on patients to document that they are eligible for an exemption and an unnecessary and unjustified burden on physicians who may be asked to attest that their patients have an exempted medical condition. 2019 Physician Fee Schedule and Quality Payment Program: Advocated to CMS that: cognitive care of more complex patients must be recognized with higher allowed payment rates than less complex care patients; supports the overall direction of CMS's proposal to reduce the burden of documentation for E/M services, but strongly disagrees that such improvements should be contingent on acceptance of the proposal to pay a single flat fee for levels 2-5; CMS not establish a regulatory deadline (e.g. January 1, 2019 or January 1, 2020) for finalizing and implementing its flat fee E/M proposals or possible alternatives that change how E/M services would be paid; calls on CMS to move forward with implementation of their proposal to simplify E/M documentation requirements effective January 1, 2019, while alternatives to the flat fee structure are being developed and pilot-tested; supports implementation on January 1, 2019 of proposals to pay for virtual check-ins, other telehealth and technology-based services, and prolonged face-to-face visits. Short-Term Health Plans: Urged Congress to support the joint resolutions disapproving of the rule related to short-term, limited-duration insurance, as published in the federal register on August 3, 2018, that such rule shall have no force or effect.

Client expense: $279,872 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), President of the U.S., SENATE

Preserve Access to Primary Care Services: Address the shortage of primary care physicians; provide scholarships and loan forgiveness in exchange for primary care service commitments to practice in critical shortage areas; provide grants for medical school mentorship programs and primary care training in community health centers; increase Title VII funding for primary care health programs; increase funding for the National Health Service Corps, provide regulatory relief for primary care physicians; H.R. 7192/S. 1174, the Preserving Patient Access to Primary Care Act (as first introduced in the 111th Congress). Support the Affordable Care Act (P.L. 111-148, P.L. 111-152) by: Expanding coverage and improving Medicare benefits; Providing needed protections to guard against insurance practices that unfairly limit, deny or rescind coverage based on health status; public and private health insurers should encourage preventive health care by providing full coverage, with no cost-sharing, for preventive services recommended by an expert advisory group, such as the U.S. Preventive Services Task Force; Ensuring access to primary care physicians; and beginning to bend the cost curve; Prohibiting insurers from excluding or charging excessive rates to children based on pre-existing conditions, which later will be expanded to all persons; Covering young adults on their parents' plans; Eliminating lifetime and annual limits on health insurance coverage; Requiring that health insurers spend more on patient care and less on administration; support enactment of S. 248, the Empowering States to Innovate Act, which amends the Patient Protection and Affordable Care Act (ACA) to: (1) allow states to apply for waivers of certain health insurance coverage requirements in such Act (including requirements for the establishment of qualified health plans and health insurance exchanges) for plan years beginning on or after January 1, 2014 (currently, January 1, 2017), and (2) require the waiver application process to begin not later than 180 days after the enactment of this Act; Phasing out the Medicare Part D doughnut hole; Eliminating patient cost-sharing for preventive services offered by Medicare or private insurers; Increasing Medicare and Medicaid payments to primary care physicians; Supporting the Patient-Centered Outcomes Research Institute to help physicians and patients make care decisions based on the best available evidence; Supporting the Center on Medicare and Medicaid Innovation to fund pilots of delivery models to improve outcomes and reduce costs, including patient-centered medical homes. Medicare Physician Payment Reform: Advocated in support of H.R. 2, the Medicare Access and CHIP Reauthorization Act (MACRA), which was enacted in April 2015 and repealed Medicares Sustainable Growth Rate (SGR) formula and moved us to a new value-based payment and delivery system under Medicare; Advocated with CMS on numerous aspects of the MACRA proposed and final rules, including: proposing a distinctive alternative scoring methodology, developed by ACP, which combines, simplifies, aligns and reduces the complexity of the four reporting categories that will qualify physicians for FFS payment adjustments; proposing specific alternatives to CMS Advancing Care Information program that replaced the Meaningful Use program; proposing additional improvements to simplify the reporting requirements for the Quality, Advancing Care Information and Improvement Activities categories; urging CMS to immediately create virtual reporting options and to create safe harbors for smaller practices until such options are available; proposing more options and flexibility, instead of a one-size fits all approach, for practices to be certified as Patient-Centered Medical Homes or Patient-Centered Medical Home specialty practices, qualifying them for the highest possible score for the Clinical Practice Improvement Activity reporting category; Proposing four different options for Medical Home practices to qualify as advanced Alternative Payment Models, instead of the single option proposed by CMS, including options to allow PCMHs to qualify without taking financial risk: Advocated with CMS on Patient Relationship Categories and Codes, as required by MACRA, specifically: that CMS work to ensure that patients, families, and the relationship of patients and families with their physicians are at the forefront of the Agencys thinking in the development of both the Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) pathways; that the implementation of these categories and codes is carried out in a manner that fully considers and minimizes the impact of reporting burden on the participating clinicians and that has appropriate flexibility to allow for learning and improvement in the approach by both the Agency and the clinicians. Improve Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Provide sliding scale subsidies based on income to buy coverage from qualified plans; Qualified plans should: provide evidence-based benefits, including preventive services; and be prohibited from excluding persons with pre-existing conditions, charging them more, cherry-picking enrollees, or cancelling or failing to renew coverage; Expand Medicaid to cover all persons below the Federal Poverty Level and ensure fair payments to participating physicians; As coverage becomes affordable, all persons should participate and coverage should be guaranteed; Responsibility for financing should be shared by individuals, employers and government. The College believes that strong oversight is needed when determining the initial benchmark plan (and whether it reflects the coverage requirements of the Affordable Care Act) and how the package will be updated, particularly if insurers are given the ability to substitute benefits within and across categories. State and the federal government must work in concert with physicians, health care providers and payers to determine and promote use of clinically effective and cost-effective services that result in improved patient health while bending the cost curve. Under the Affordable Care Act, advocated to ensure that people residing in states with health insurance marketplaces operated by the federal government do not lose their cost-sharing reduction subsidies (CSRs) and that those CSRs should be continued indefinitely as part of a larger bipartisan effort to stabilize the individual insurance market. Pilot test Medicare payment models that re-align incentives to support effective, efficient, patient-centered, coordinated care. Priority should be given to models designed to support the value of services provided by primary care physicians as well as to models that would create incentives, across physician specialties and sites of services, to improve the quality, effectiveness, and efficiency of care provided. Policy criteria for selecting the most promising models for pilot testing should be developed, in consultation with outside experts; The Patient-Centered Medical Home (PCMH), which has shown great promise in meeting the policy objectives suggested above, should be among the models selected for broader testing on a national pilot basis; the use of the medical home model for treatment or services under private health plans, the requirement of health plans to provide incentives to promote and report on medical home services provided, the establishment of community health teams and a primary care extension program to educate and support primary care practices in the delivery of medical home services, and the establishment of a demonstration project to educate physicians and other clinicians in training in the competencies required to deliver care consistent with the medical home care model. Veterans Care: Regarding the VA Mission Act of 2018 (H.R. 5674), the College urged Congress to ensure that veterans have access to timely, contiguous care across the spectrum of health care services, with coordination and management of that care in the hands of a primary clinician or clinical care team; that the expansion of care to non-VHA facilities does not come at the cost of maintaining or improving existing VHA services or infrastructure; and that recruitment and retention of clinicians to the VHA is valued appropriately, including reimbursement for services provided; Advocated with Congress on the need for adequate funding for the VHA for FY2019 and the long-term. Immigration: Voiced support to Congress on the need to pass the Development, Relief, and Education for Alien Minors (DREAM) Act of 2017, H.R. 3440. This legislation would establish a three-step pathway to U.S. citizenship through college, work, or the armed services for individuals who were born in another country and brought illegally to the U.S. at a young age (DREAMers). Clinical Labs: Commented to the Centers for Medicare and Medicaid Services (CMS) on issues pertaining to the Protecting Access to Medicare Act of 2014 (PAMA), specifically citing concerns about the potential impacts of PAMA on patient access to critical rapid clinical testing services offered to patients while they are receiving medical care in their physicians office; expressed further concerns about impending cuts on Jan. 1, 2018 for physician office-based testing services. Expand Coverage and Stabilizing the Insurance Market: Congress should work to help stabilize the individual health insurance market and expand coverage. Specifically by develop and introduce comprehensive market stabilization legislation that includes reinsurance options to help stabilize the markets; Expanding cost-sharing assistance eligibility to purchase insurance in the exchanges as well as increase the level of premium tax credits and cost sharing subsidies offered to purchase a qualified health plan; Introducing legislation that would block the expansion of access to short-term health plans or Association Health Plans that allow insurers to charge more to individuals with pre-existing conditions and permit them to exclude from coverage essential medical care; Supporting $690 million in discretionary funding for federal exchanges within CMS Program Operations as part of the FY2019 Labor, Health and Human Services, and Education Appropriations bill. Reduce Unnecessary Administrative Tasks on Physicians and Patients: Congress should accelerate its efforts to reduce administrative burdens on clinicians and patients, including: Passing the Standardizing Electronic Prior Authorization for Safe Prescribing Act (H.R. 4841), which standardizes electronic prior authorization for prescription drugs under Medicare Part D. Adopt even greater harmonization of such standards across the health care industry; Passing the CONNECTIONS Act (H.R. 5812) by Reps. Griffith (R-VA) and Pallone (D-NJ) that would authorize CDC grants to state-run PDMPs to improve data collection and integration into physician clinical workflow specifically, of controlled substances overdose prevention and surveillance activities; Urging health care committees in Congress with jurisdiction over Medicare to exercise their oversight authority of CMS effort to overhaul clinical documentation guidelines with input from practicing clinicians; Passing the Improving Access to Medicare Coverage Act of 2017 (S. 568/H.R. 1421), which deems patients under observation as inpatients for the purposes of satisfying the Medicare 3-day inpatient stay requirement. Reduce Prescription Drug Costs: Congress should increase transparency and accountability in prescription drug pricing and improve access to lower-cost generic medications by passing the Drug Price Transparency in Communications Act (S. 2157), which would require drug companies to disclose the Wholesale Acquisition Cost of an Rx in Direct-to-Consumer Advertising. Representatives should introduce the companion bill; Passing the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2017 (S. 974/H.R. 2212), which would improve patient access to alternative low-cost prescription drugs and biological products by preventing prescription drug manufacturers from misusing the FDAs Risk Evaluation and Mitigation Strategies (REMS) process to make it difficult for competing generics to be brought to the market; Passing the Medicare Prescription Drug Price Negotiation Act of 2017 (S. 41/H.R. 242), which would grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for high�cost drugs and biologics covered under Part D; Passing the Fair Accountability and Innovative Research (FAIR) Pricing Act (S. 1131/H.R. 2439), which would require drug manufacturers to disclose and provide more information about planned drug price increases, including R&D costs. Fund Workforce, Medical and Health Services Research, Public Health Initiatives: Congress should ensure funding in FY 2019 for federal programs/initiatives designed to support primary care and reject funding rescissions that would harm childrens health coverage or CMS Innovation Center. This includes funding the Primary Care and Training Enhancement (PCTE) at $71 million in order to maintain and expand the pipeline for individuals training in primary care; Funding the National Health Service Corps (NHSC) at least at $415 million in total program funding to fund scholarships and loan repayment to health care professionals to help expand the countrys primary care workforce and meet the health care needs of underserved communities; Funding the Centers for Disease Control and Prevention (CDC) and Prevention and Public Health Fund (PPHF) at $8.45 billion; including PPHF funding at $805 million; Funding the Agency for Healthcare Research and Quality (AHRQ) at $454 million, restoring the agency to its FY2010 enacted level adjusting for inflation after cuts in FY2016 and FY2017 and a small increase in FY2018 so it can help clinicians help patients by making evidence-informed decisions, fund research that serves as the evidence engine for much of the private sectors work to keep patients safe; Funding the National Institutes of Health (NIH) at $39 billion so that this nations biomedical research can continue to fund cures for disease and maintain the U.S. standing as the world leader in medical and biomedical research. Promote Continued Action to Address the Epidemic of Opioid Use: Congress should pass a comprehensive legislative package to improve prevention, education, treatment and recovery for those suffering from opioid-related addictions, including: Providing for sufficient and increased funding to address the opioid epidemic, building and expanding upon the $4.65 billion in the omnibus bill approved by Congress, with at least $1 billion for programs as authorized by CARA 2.0; Expanding access and coverage for medication assisted treatment (methadone, buprenorphine, and naltrexone to prevent opioid and substance use disorders; Rejecting any proposal to impose a three day prescribing limit for initial opioid prescriptions to ensure that doctors have appropriate flexibility to determine the proper duration of each opioid prescription; Passing the Comprehensive Addiction and Recovery Act 2.0 of 2018 (S. 2456/H.R. 5311) as a step toward a more comprehensive opioids-related package. Reduce Firearms-Related Injury and Death: Congress should pass the Assault Weapons Ban of 2018 (S. 2095/H.R. 5077), which would ban the sale of high velocity, rapid file assault rifles and large capacity ammunition magazines and bump stocks; Pass the Brady Background Expansion Act (S. 2009), to expand background checks to virtually all firearm sales in the United States; Pass the Stop Illegal Trafficking in Firearms Act of 2017 (S. 1185), and the Stop Straw Purchases Act (H.R. 5134). Both would increase penalties for individuals who unlawfully purchase firearms for other persons who are prohibited from possessing firearms (known as straw purchasers); Repeal the Dickey amendment restricting firearms-related research by federal agencies and support $50 million in funding for the CDC to conduct such research; Pass S. 834/H.R. 1832 that authorizes funding for the CDC to conduct such research. Make Graduate Medical Education (GME) Funding More Effective: Congress should develop and pass legislation to reform GME to prioritize funding toward physician specialties where millions of patients lack access, including internal medicine specialists trained in comprehensive primary care, to: Increase the number of GME slots by at least 3,000 per year over five years for specialties facing shortages, including internal medicine, as contained in the Resident Physician Shortage Reduction Act of 2017 (S. 1301/H.R. 2267); Combine DGME/IME into a single, more functional program; broaden the GME financing structure to include all payers; Allocate GME funds transparently and to activities that further the educational mission of teaching and training residents/fellows with input from practicing clinicians and in collaboration with their professional organizations; Support continued adequate funding for the VHA and its substantial contributions to the ongoing training of the next generation of physicians. Title X Regulations: Commented to HHS in July on the proposed rule to revise Title X regulations (Title X of the Public Health Service Act) to ensure compliance with, and enhance implementation of, the statutory requirement that none of the funds appropriated for Title X may be used in programs where pregnancy termination is a method of family planning and related statutory requirements. The College asserts that women should have sufficient access to evidence-based family planning and sexual health information and the full range of medically accepted forms of contraception. The College opposes government restrictions that would erode or abrogate a woman's right to continue or discontinue a pregnancy. The College opposes any legislation or regulations that limit access to comprehensive reproductive health care by putting medically unnecessary restrictions on health care professionals or facilities. Kentucky Health Waiver: The College commented to CMS on Kentuckys Health Waiver expressing concern that: it would impose a substantial monthly premium on Medicaid beneficiaries; would also create a six-month lock-out period for certain enrollees who do not pay their premiums on time, which is unduly harsh; that proposed work requirements will impose an unnecessary and unjustified burden on patients to document that they are eligible for an exemption and an unnecessary and unjustified burden on physicians who may be asked to attest that their patients have an exempted medical condition. 2019 Physician Fee Schedule and Quality Payment Program: Advocated to CMS that: cognitive care of more complex patients must be recognized with higher allowed payment rates than less complex care patients; supports the overall direction of CMS's proposal to reduce the burden of documentation for E/M services, but strongly disagrees that such improvements should be contingent on acceptance of the proposal to pay a single flat fee for levels 2-5; CMS not establish a regulatory deadline (e.g. January 1, 2019 or January 1, 2020) for finalizing and implementing its flat fee E/M proposals or possible alternatives that change how E/M services would be paid; calls on CMS to move forward with implementation of their proposal to simplify E/M documentation requirements effective January 1, 2019, while alternatives to the flat fee structure are being developed and pilot-tested; supports implementation on January 1, 2019 of proposals to pay for virtual check-ins, other telehealth and technology-based services, and prolonged face-to-face visits. Short-Term Health Plans: Urged Congress to support the joint resolutions disapproving of the rule related to short-term, limited-duration insurance, as published in the federal register on August 3, 2018, that such rule shall have no force or effect.

Client expense: $97,099 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), President of the U.S., SENATE

Discussed efforts to include harmful prescription drug policies in NAFTA with House and Senate staff. H.R. 2212/ S. 974, CREATES Act - Discussed support of bill. H.R. 2439/S.1131, FAIR Drug Pricing Act - Discussed support of bill. S. 124, The Preserve Access to Affordable Generics Act - Discussed support of bill. Part D Deal in Bipartisan Budget Act, Met with House offices to reiterate our support for the deal; sent multiple letters to House and Senate leadership; discussed support for the deal with House and Senate staff. Discussed the Presidents Prescription Drug Blueprint and RFI. S. 1091, the Supporting Grandparents Raising Grandkids Act - Advocated for passage of bill. S. 2553, Know the Lowest Price Act - Endorsed legislation. S.2554, Patient Right to Know Act - Endorsed legislation. Discussed opioid abuse legislation to address opioid abuse and misuse. Discussed possible ways to improve Medicare Part D. Discussed Rx Price Watch Reports and the impact of high drug costs. Discussed drug pricing reforms AARP supports, including secretarial negotiation, importation, reducing exclusivity for biologics, and ending pay-for-delay deals. Discussed family caregiving, opioids, and Supporting Grandparents Raising Grandchildren Act (P.L. 115-196, S. 1091/H.R. 3105).

Client expense: $1,740,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Federal Highway Administration (FHA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Housing & Urban Development, Dept of (HUD), Labor, Dept of (DOL), Natl Highway Traffic Safety Administration (NHTSA), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, White House Office

H.R.1776/ S.771, Improving Access To Affordable Prescription Drugs Act H.R. 2439/ S.1131, Fair Accountability and Innovative Research Drug Pricing Act S.1348, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act H.R.4385, Responsibility in Drug Advertising Act H.R.4116, Transparent Drug Pricing Act S.2157, Drug-Price Transparency in Communications Act S.2478, End Taxpayer Subsidies for Drug Ads Act FTC Reauthorization Act of 2018 (Not introduced)

Client expense: Not reported · Firm income: $90,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to S.2315 "Over-the-Counter Drug Safety, Innovation, and Reform Act; general issues related to drug pricing;issues related to cosmetic regulations; issues related to insulin pricing;issues related to Pandemic and All Hazards Preparedness (PAHPA)reauthorization; issues related to Medicare Part D; issues related to flu and Veterans Affairs; issues related to seasonal influenza vaccination; issues related to Right to Try; issues related to 340B Reform; issues related to Drug Importation; issues related to vaccine safety;issues related to HR5333 "Over-the-Counter Monograph Safety, Innovation, and reform Act of 2018; issues related to FDA User Fee Reauthorization; issues related to HR2212 "CREATES Act of 2017"; and issues related to HR 2439 "Fair Accountability and Innovation Research Drug Act of 2017".

Client expense: $1,100,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Prescription drug pricing. S. 974 - CREATES Act. S. 1131 and H.R. 2439 - Fair Accountability and Innovative Research Drug Pricing Act H.R. 2051 - FAST Generics Act of 2017 Medicare Part D Biosimilars.

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Prescription drug pricing. S. 974 - CREATES Act. S. 1131 and H.R. 2439 - Fair Accountability and Innovative Research Drug Pricing Act H.R. 2051 - FAST Generics Act of 2017. Medicare Part D Biosimilars.

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S. 92: Safe and Affordable Drugs from Canada Act S. 201 / H.R. 5247: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 S. 469: Affordable and Safe Prescription Drug Importation Act S. 1131/ H.R. 2439: FAIR Drug Pricing Act S. 2260 / H.R. 4733: Opioids and STOP Pain Initiative Act H.R. 1776: Improving Access to Affordable Prescription Drugs Act H.R. 1876: Good Samaritan Health Professionals Act of 2017 H.R. 2077: the Restoring the Patient's Voice Act of 2017 H.R. 4116: Transparent Drug Pricing Act of 2017 S. 2387 / H.R. 4957: Concentrating on High-Value Alzheimers Needs to Get to an End (CHANGE) Act S. 2406: Advancing Cutting Edge (ACE) Research Act S. 2478: End Taxpayer Subsidies for Drug Ads Act S. 2680: Opioid Crisis Response Act of 2018 S. 2891: Fighting the Opioid Epidemic with Sunshine Act H.R. 5634: Medical Cannabis Research Act Maintenance/expansion of Graduate Medical Education (GME); encouraging drug price transparency; NIH funding including the BRAIN Initiative; Congressionally-Directed Medical Research Program funding; concussion related issues.

Client expense: Not reported · Firm income: $220,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, FDA Accelerated Approval and Breakthrough Therapy Status. Discussion Draft of H.R.__, FDA and International Mail. Discussion Draft of H.R.__, Opioid Sparing. Discussion Draft of H.R.__, Packaging and Disposal. Discussion Draft of H.R.__, Long-term Efficiency. Discussion Draft of H.R.__, Misuse/Abuse.

Client expense: $800,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)

Sent a letter to USTR regarding prescription drugs concerns in NAFTA negotiations. Sent letter supporting the inclusion of H.R. 3032, the Mental Health Access Improvement Act, in larger opioids bill, H.R. 5531, the Opioid Emergency Response Act. Participated in stakeholder calls organized by the White House and HHS on the Presidents Prescription Drug Blueprint. H.R. 2212/ S. 974, CREATES Act - Discussed support of bill. H.R. 2439/S.1131, FAIR Drug Pricing Act - Discussed support of bill. S. 124, The Preserve Access to Affordable Generics Act - Discussed support of bill. Part D Deal in Bipartisan Budget Act - Met with House offices to reiterate our support for the deal; sent a letter to House and Senate leadership; discussed support for the deal with Senate staff. Discussed the Presidents Prescription Drug Blueprint and RFI. S. 1091, the Supporting Grandparents Raising Grandkids Act - Advocated for passage of bill. S. 2553, Know the Lowest Price Act - Sent letter of endorsement. S.2554, Patient Right to Know Act - Sent letter of endorsement. Discussed Committee activities on opioid abuse legislation to address opioid abuse and misuse. Discussed possible ways to improve Medicare Part D. Discussed Rx Price Watch Reports and the impact of high drug costs. Discussed drug pricing reforms AARP supporting, including secretarial negotiation, importation, reducing exclusivity for biologics, and ending pay-for-delay deals. Discussed family caregiving, opioids, and Supporting Grandparents Raising Grandchildren Act (P.L. 115-196, S. 1091/H.R. 3105).

Client expense: $2,220,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Consumer Financial Protection Bureau (CFPB), Federal Communications Commission (FCC), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Housing & Urban Development, Dept of (HUD), Natl Highway Traffic Safety Administration (NHTSA), Office of Management & Budget (OMB), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office

Prescription drug pricing. S. 974 - CREATES Act. S. 1131 and H.R. 2439 - Fair Accountability and Innovative Research Drug Pricing Act. H.R. 2051 - FAST Generics Act of 2017. Medicare Part D Biosimilars.

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Prescription drug pricing. S. 974 - CREATES Act. S. 1131 and H.R. 2439 - Fair Accountability and Innovative Research Drug Pricing Act. H.R. 2051 - FAST Generics Act of 2017. Medicare Part D Biosimilars.

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S. 297, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug costs S. 974, CREATES Act (Leahy-Grassley) - access to generic drugs and biosimilars S. 1115, Making Pharmaceutical Markets More Competitive Act (Collins-McCaskill) - accelerated approval of generic therapies S. 1131, FAIR Drug Pricing Act (Baldwin-McCain) - transparency in prescription drug pricing S. 2553, Know the Lowest Price Act (Stabenow) - information on drug prices S. 2554, Patient Right to Know Drug Prices Act (Collins) - information on drug prices H.R. 749, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug costs H.R. 1703, Medical Product Communication Act (Griffith) - off-label exchange of information H.R. 2026, Pharmaceutical Information Exchange Act (Guthrie) - pre-approval health care economic information to payors H.R. 2051, Fair Access for Safe and Timely Generics Act (McKinley-Welch) - access to generic drugs H.R. 2212, CREATES Act (Marino-Cicilline) - access to generic drugs and biosimilars H.R. 2439, FAIR Drug Pricing Act (Schakowsky) - transparency in prescription drug pricing H.R. 2562, Making Pharmaceutical Markets More Competitive Act (Kelly) - accelerated approval of generic therapies H.R. 2999, Patients' Access to Treatments Act (McKinley) - limiting cost sharing in specialty drug tiers H.R. 5247, Right to Try Act (Fitzpatrick) - use of unapproved investigational drugs by patients with life-threatening conditions H.R. 6142, Reducing Drug Waste Act (Doggett) - packaging of medications 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; issues relating to opioids; issues relating to prescription drug price blueprint; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Client expense: $1,410,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

-Bipartisan Health Care Stabilization Act, support bipartisan efforts led by Senators Alexander and Murray to stabilize and improve the individual health insurance market while protecting people with chronic conditions. -H.R. 2439/S. 1131, FAIR Drug Pricing Act, support passage. - H.R. 2212/ S. 974, Creating and Restoring Equal Access To Equivalent Samples Act of 2017 (CREATES Act), support passage. -H.R. 2077, Restoring Patients Voice Act, support passage. -S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act, support passage. -H.R. 4841/S. 2908, Standardizing Electronic Prior Authorization for Safe Prescribing Act, support passage. - H.R. 2051, Fair Access for Safe and Timely Generics Act of 2017 (FAST Generics Act), support passage. -H.R. 750, support passage of the Ensuring Access to Quality Complex Rehabilitation Technology Act. -H.R. 1361/S. 486/H.R. 3730, support passage to protect access to complex rehabilitative technology accessories. -H.R. 2535/S. 1188, Lifespan Respite Care Reauthorization Act, support reauthorization of the Lifespan Respite Care Program. -HR 2575/S. 1909, Beneficiary Enrollment Notification and Eligibility Simplification (BENES) Act

Client expense: $100,029 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Preserve Access to Primary Care Services: Address the shortage of primary care physicians; provide scholarships and loan forgiveness in exchange for primary care service commitments to practice in critical shortage areas; provide grants for medical school mentorship programs and primary care training in community health centers; increase Title VII funding for primary care health programs; increase funding for the National Health Service Corps, provide regulatory relief for primary care physicians; H.R. 7192/S. 1174, the Preserving Patient Access to Primary Care Act (as first introduced in the 111th Congress). Support the Affordable Care Act (P.L. 111-148, P.L. 111-152) by: Expanding coverage and improving Medicare benefits; Providing needed protections to guard against insurance practices that unfairly limit, deny or rescind coverage based on health status; public and private health insurers should encourage preventive health care by providing full coverage, with no cost-sharing, for preventive services recommended by an expert advisory group, such as the U.S. Preventive Services Task Force; Ensuring access to primary care physicians; and beginning to bend the cost curve; Prohibiting insurers from excluding or charging excessive rates to children based on pre-existing conditions, which later will be expanded to all persons; Covering young adults on their parents' plans; Eliminating lifetime and annual limits on health insurance coverage; Requiring that health insurers spend more on patient care and less on administration; support enactment of S. 248, the Empowering States to Innovate Act, which amends the Patient Protection and Affordable Care Act (ACA) to: (1) allow states to apply for waivers of certain health insurance coverage requirements in such Act (including requirements for the establishment of qualified health plans and health insurance exchanges) for plan years beginning on or after January 1, 2014 (currently, January 1, 2017), and (2) require the waiver application process to begin not later than 180 days after the enactment of this Act; Phasing out the Medicare Part D doughnut hole; Eliminating patient cost-sharing for preventive services offered by Medicare or private insurers; Increasing Medicare and Medicaid payments to primary care physicians; Supporting the Patient-Centered Outcomes Research Institute to help physicians and patients make care decisions based on the best available evidence; Supporting the Center on Medicare and Medicaid Innovation to fund pilots of delivery models to improve outcomes and reduce costs, including patient-centered medical homes. Medicare Physician Payment Reform: Advocated in support of H.R. 2, the Medicare Access and CHIP Reauthorization Act (MACRA), which was enacted in April 2015 and repealed Medicares Sustainable Growth Rate (SGR) formula and moved us to a new value-based payment and delivery system under Medicare; Advocated with CMS on numerous aspects of the MACRA proposed and final rules, including: proposing a distinctive alternative scoring methodology, developed by ACP, which combines, simplifies, aligns and reduces the complexity of the four reporting categories that will qualify physicians for FFS payment adjustments; proposing specific alternatives to CMS Advancing Care Information program that replaced the Meaningful Use program; proposing additional improvements to simplify the reporting requirements for the Quality, Advancing Care Information and Improvement Activities categories; urging CMS to immediately create virtual reporting options and to create safe harbors for smaller practices until such options are available; proposing more options and flexibility, instead of a one-size fits all approach, for practices to be certified as Patient-Centered Medical Homes or Patient-Centered Medical Home specialty practices, qualifying them for the highest possible score for the Clinical Practice Improvement Activity reporting category; Proposing four different options for Medical Home practices to qualify as advanced Alternative Payment Models, instead of the single option proposed by CMS, including options to allow PCMHs to qualify without taking financial risk: Advocated with CMS on Patient Relationship Categories and Codes, as required by MACRA, specifically: that CMS work to ensure that patients, families, and the relationship of patients and families with their physicians are at the forefront of the Agencys thinking in the development of both the Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) pathways; that the implementation of these categories and codes is carried out in a manner that fully considers and minimizes the impact of reporting burden on the participating clinicians and that has appropriate flexibility to allow for learning and improvement in the approach by both the Agency and the clinicians. Improve Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Provide sliding scale subsidies based on income to buy coverage from qualified plans; Qualified plans should: provide evidence-based benefits, including preventive services; and be prohibited from excluding persons with pre-existing conditions, charging them more, cherry-picking enrollees, or cancelling or failing to renew coverage; Expand Medicaid to cover all persons below the Federal Poverty Level and ensure fair payments to participating physicians; As coverage becomes affordable, all persons should participate and coverage should be guaranteed; Responsibility for financing should be shared by individuals, employers and government. The College believes that strong oversight is needed when determining the initial benchmark plan (and whether it reflects the coverage requirements of the Affordable Care Act) and how the package will be updated, particularly if insurers are given the ability to substitute benefits within and across categories. State and the federal government must work in concert with physicians, health care providers and payers to determine and promote use of clinically effective and cost-effective services that result in improved patient health while bending the cost curve. Under the Affordable Care Act, advocated to ensure that people residing in states with health insurance marketplaces operated by the federal government do not lose their cost-sharing reduction subsidies (CSRs) and that those CSRs should be continued indefinitely as part of a larger bipartisan effort to stabilize the individual insurance market. Pilot test Medicare payment models that re-align incentives to support effective, efficient, patient-centered, coordinated care. Priority should be given to models designed to support the value of services provided by primary care physicians as well as to models that would create incentives, across physician specialties and sites of services, to improve the quality, effectiveness, and efficiency of care provided. Policy criteria for selecting the most promising models for pilot testing should be developed, in consultation with outside experts; The Patient-Centered Medical Home (PCMH), which has shown great promise in meeting the policy objectives suggested above, should be among the models selected for broader testing on a national pilot basis; the use of the medical home model for treatment or services under private health plans, the requirement of health plans to provide incentives to promote and report on medical home services provided, the establishment of community health teams and a primary care extension program to educate and support primary care practices in the delivery of medical home services, and the establishment of a demonstration project to educate physicians and other clinicians in training in the competencies required to deliver care consistent with the medical home care model. Maternal Health: Advocated for the Preventing Maternal Deaths Act, H.R. 1318, which supports state Maternal Mortality Review Committees, and promotes national information sharing through the Centers for Disease Control and Prevention (CDC), so that states can continue to learn from best practices and collaborate as needed. This bill will also put data to work through demonstration projects to eliminate disparities in maternal health outcomes. Veterans Care: Regarding the VA Mission Act of 2018 (H.R. 5674), the College urged Congress to ensure that veterans have access to timely, contiguous care across the spectrum of health care services, with coordination and management of that care in the hands of a primary clinician or clinical care team; that the expansion of care to non-VHA facilities does not come at the cost of maintaining or improving existing VHA services or infrastructure; and that recruitment and retention of clinicians to the VHA is valued appropriately, including reimbursement for services provided. Non-discrimination Protections: Urged the U.S. Department of Health and Human Services not to weaken nondiscrimination protections for lesbian, gay, bisexual, transgender, and questioning (LGBTQ) individuals under Section 1557 of the Affordable Care Act. Immigration: Voiced support to Congress on the need to pass the Development, Relief, and Education for Alien Minors (DREAM) Act of 2017, H.R. 3440. This legislation would establish a three-step pathway to U.S. citizenship through college, work, or the armed services for individuals who were born in another country and brought illegally to the U.S. at a young age (DREAMers). Clinical Labs: Commented to the Centers for Medicare and Medicaid Services (CMS) on issues pertaining to the Protecting Access to Medicare Act of 2014 (PAMA), specifically citing concerns about the potential impacts of PAMA on patient access to critical rapid clinical testing services offered to patients while they are receiving medical care in their physicians office; expressed further concerns about impending cuts on Jan. 1, 2018 for physician office-based testing services. Expand Coverage and Stabilizing the Insurance Market: Congress should work to help stabilize the individual health insurance market and expand coverage. Specifically by develop and introduce comprehensive market stabilization legislation that includes reinsurance options to help stabilize the markets; Expanding cost-sharing assistance eligibility to purchase insurance in the exchanges as well as increase the level of premium tax credits and cost sharing subsidies offered to purchase a qualified health plan; Introducing legislation that would block the expansion of access to short-term health plans or Association Health Plans that allow insurers to charge more to individuals with pre-existing conditions and permit them to exclude from coverage essential medical care; Supporting $690 million in discretionary funding for federal exchanges within CMS Program Operations as part of the FY2019 Labor, Health and Human Services, and Education Appropriations bill. Reduce Unnecessary Administrative Tasks on Physicians and Patients: Congress should accelerate its efforts to reduce administrative burdens on clinicians and patients, including: Passing the Standardizing Electronic Prior Authorization for Safe Prescribing Act (H.R. 4841), which standardizes electronic prior authorization for prescription drugs under Medicare Part D. Adopt even greater harmonization of such standards across the health care industry; Passing the CONNECTIONS Act (H.R. 5812) by Reps. Griffith (R-VA) and Pallone (D-NJ) that would authorize CDC grants to state-run PDMPs to improve data collection and integration into physician clinical workflow specifically, of controlled substances overdose prevention and surveillance activities; Urging health care committees in Congress with jurisdiction over Medicare to exercise their oversight authority of CMS effort to overhaul clinical documentation guidelines with input from practicing clinicians; Passing the Improving Access to Medicare Coverage Act of 2017 (S. 568/H.R. 1421), which deems patients under observation as inpatients for the purposes of satisfying the Medicare 3-day inpatient stay requirement. Reduce Prescription Drug Costs: Congress should increase transparency and accountability in prescription drug pricing and improve access to lower-cost generic medications by passing the Drug Price Transparency in Communications Act (S. 2157), which would require drug companies to disclose the Wholesale Acquisition Cost of an Rx in Direct-to-Consumer Advertising. Representatives should introduce the companion bill; Passing the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2017 (S. 974/H.R. 2212), which would improve patient access to alternative low-cost prescription drugs and biological products by preventing prescription drug manufacturers from misusing the FDAs Risk Evaluation and Mitigation Strategies (REMS) process to make it difficult for competing generics to be brought to the market; Passing the Medicare Prescription Drug Price Negotiation Act of 2017 (S. 41/H.R. 242), which would grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for high�cost drugs and biologics covered under Part D; Passing the Fair Accountability and Innovative Research (FAIR) Pricing Act (S. 1131/H.R. 2439), which would require drug manufacturers to disclose and provide more information about planned drug price increases, including R&D costs. Fund Workforce, Medical and Health Services Research, Public Health Initiatives: Congress should ensure funding in FY 2019 for federal programs/initiatives designed to support primary care and reject funding rescissions that would harm childrens health coverage or CMS Innovation Center. This includes funding the Primary Care and Training Enhancement (PCTE) at $71 million in order to maintain and expand the pipeline for individuals training in primary care; Funding the National Health Service Corps (NHSC) at least at $415 million in total program funding to fund scholarships and loan repayment to health care professionals to help expand the countrys primary care workforce and meet the health care needs of underserved communities; Funding the Centers for Disease Control and Prevention (CDC) and Prevention and Public Health Fund (PPHF) at $8.45 billion; including PPHF funding at $805 million; Funding the Agency for Healthcare Research and Quality (AHRQ) at $454 million, restoring the agency to its FY2010 enacted level adjusting for inflation after cuts in FY2016 and FY2017 and a small increase in FY2018 so it can help clinicians help patients by making evidence-informed decisions, fund research that serves as the evidence engine for much of the private sectors work to keep patients safe; Funding the National Institutes of Health (NIH) at $39 billion so that this nations biomedical research can continue to fund cures for disease and maintain the U.S. standing as the world leader in medical and biomedical research. Promote Continued Action to Address the Epidemic of Opioid Use: Congress should pass a comprehensive legislative package to improve prevention, education, treatment and recovery for those suffering from opioid-related addictions, including: Providing for sufficient and increased funding to address the opioid epidemic, building and expanding upon the $4.65 billion in the omnibus bill approved by Congress, with at least $1 billion for programs as authorized by CARA 2.0; Expanding access and coverage for medication assisted treatment (methadone, buprenorphine, and naltrexone to prevent opioid and substance use disorders; Rejecting any proposal to impose a three day prescribing limit for initial opioid prescriptions to ensure that doctors have appropriate flexibility to determine the proper duration of each opioid prescription; Passing the Comprehensive Addiction and Recovery Act 2.0 of 2018 (S. 2456/H.R. 5311) as a step toward a more comprehensive opioids-related package. Reduce Firearms-Related Injury and Death: Congress should pass the Assault Weapons Ban of 2018 (S. 2095/H.R. 5077), which would ban the sale of high velocity, rapid file assault rifles and large capacity ammunition magazines and bump stocks; Pass the Brady Background Expansion Act (S. 2009), to expand background checks to virtually all firearm sales in the United States; Pass the Stop Illegal Trafficking in Firearms Act of 2017 (S. 1185), and the Stop Straw Purchases Act (H.R. 5134). Both would increase penalties for individuals who unlawfully purchase firearms for other persons who are prohibited from possessing firearms (known as straw purchasers); Repeal the Dickey amendment restricting firearms-related research by federal agencies and support $50 million in funding for the CDC to conduct such research; Pass S. 834/H.R. 1832 that authorizes funding for the CDC to conduct such research. Make Graduate Medical Education (GME) Funding More Effective: Congress should develop and pass legislation to reform GME to prioritize funding toward physician specialties where millions of patients lack access, including internal medicine specialists trained in comprehensive primary care, to: Increase the number of GME slots by at least 3,000 per year over five years for specialties facing shortages, including internal medicine, as contained in the Resident Physician Shortage Reduction Act of 2017 (S. 1301/H.R. 2267); Combine DGME/IME into a single, more functional program; broaden the GME financing structure to include all payers; Allocate GME funds transparently and to activities that further the educational mission of teaching and training residents/fellows with input from practicing clinicians and in collaboration with their professional organizations; Support continued adequate funding for the VHA and its substantial contributions to the ongoing training of the next generation of physicians.

Client expense: $388,427 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), President of the U.S., SENATE

Preserve Access to Primary Care Services: Address the shortage of primary care physicians; provide scholarships and loan forgiveness in exchange for primary care service commitments to practice in critical shortage areas; provide grants for medical school mentorship programs and primary care training in community health centers; increase Title VII funding for primary care health programs; increase funding for the National Health Service Corps, provide regulatory relief for primary care physicians; H.R. 7192/S. 1174, the Preserving Patient Access to Primary Care Act (as first introduced in the 111th Congress). Support the Affordable Care Act (P.L. 111-148, P.L. 111-152) by: Expanding coverage and improving Medicare benefits; Providing needed protections to guard against insurance practices that unfairly limit, deny or rescind coverage based on health status; public and private health insurers should encourage preventive health care by providing full coverage, with no cost-sharing, for preventive services recommended by an expert advisory group, such as the U.S. Preventive Services Task Force; Ensuring access to primary care physicians; and beginning to bend the cost curve; Prohibiting insurers from excluding or charging excessive rates to children based on pre-existing conditions, which later will be expanded to all persons; Covering young adults on their parents' plans; Eliminating lifetime and annual limits on health insurance coverage; Requiring that health insurers spend more on patient care and less on administration; support enactment of S. 248, the Empowering States to Innovate Act, which amends the Patient Protection and Affordable Care Act (ACA) to: (1) allow states to apply for waivers of certain health insurance coverage requirements in such Act (including requirements for the establishment of qualified health plans and health insurance exchanges) for plan years beginning on or after January 1, 2014 (currently, January 1, 2017), and (2) require the waiver application process to begin not later than 180 days after the enactment of this Act; Phasing out the Medicare Part D doughnut hole; Eliminating patient cost-sharing for preventive services offered by Medicare or private insurers; Increasing Medicare and Medicaid payments to primary care physicians; Supporting the Patient-Centered Outcomes Research Institute to help physicians and patients make care decisions based on the best available evidence; Supporting the Center on Medicare and Medicaid Innovation to fund pilots of delivery models to improve outcomes and reduce costs, including patient-centered medical homes. Medicare Physician Payment Reform: Advocated in support of H.R. 2, the Medicare Access and CHIP Reauthorization Act (MACRA), which was enacted in April 2015 and repealed Medicares Sustainable Growth Rate (SGR) formula and moved us to a new value-based payment and delivery system under Medicare; Advocated with CMS on numerous aspects of the MACRA proposed and final rules, including: proposing a distinctive alternative scoring methodology, developed by ACP, which combines, simplifies, aligns and reduces the complexity of the four reporting categories that will qualify physicians for FFS payment adjustments; proposing specific alternatives to CMS Advancing Care Information program that replaced the Meaningful Use program; proposing additional improvements to simplify the reporting requirements for the Quality, Advancing Care Information and Improvement Activities categories; urging CMS to immediately create virtual reporting options and to create safe harbors for smaller practices until such options are available; proposing more options and flexibility, instead of a one-size fits all approach, for practices to be certified as Patient-Centered Medical Homes or Patient-Centered Medical Home specialty practices, qualifying them for the highest possible score for the Clinical Practice Improvement Activity reporting category; Proposing four different options for Medical Home practices to qualify as advanced Alternative Payment Models, instead of the single option proposed by CMS, including options to allow PCMHs to qualify without taking financial risk: Advocated with CMS on Patient Relationship Categories and Codes, as required by MACRA, specifically: that CMS work to ensure that patients, families, and the relationship of patients and families with their physicians are at the forefront of the Agencys thinking in the development of both the Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) pathways; that the implementation of these categories and codes is carried out in a manner that fully considers and minimizes the impact of reporting burden on the participating clinicians and that has appropriate flexibility to allow for learning and improvement in the approach by both the Agency and the clinicians. Improve Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Provide sliding scale subsidies based on income to buy coverage from qualified plans; Qualified plans should: provide evidence-based benefits, including preventive services; and be prohibited from excluding persons with pre-existing conditions, charging them more, cherry-picking enrollees, or cancelling or failing to renew coverage; Expand Medicaid to cover all persons below the Federal Poverty Level and ensure fair payments to participating physicians; As coverage becomes affordable, all persons should participate and coverage should be guaranteed; Responsibility for financing should be shared by individuals, employers and government. The College believes that strong oversight is needed when determining the initial benchmark plan (and whether it reflects the coverage requirements of the Affordable Care Act) and how the package will be updated, particularly if insurers are given the ability to substitute benefits within and across categories. State and the federal government must work in concert with physicians, health care providers and payers to determine and promote use of clinically effective and cost-effective services that result in improved patient health while bending the cost curve. Under the Affordable Care Act, advocated to ensure that people residing in states with health insurance marketplaces operated by the federal government do not lose their cost-sharing reduction subsidies (CSRs) and that those CSRs should be continued indefinitely as part of a larger bipartisan effort to stabilize the individual insurance market. Pilot test Medicare payment models that re-align incentives to support effective, efficient, patient-centered, coordinated care. Priority should be given to models designed to support the value of services provided by primary care physicians as well as to models that would create incentives, across physician specialties and sites of services, to improve the quality, effectiveness, and efficiency of care provided. Policy criteria for selecting the most promising models for pilot testing should be developed, in consultation with outside experts; The Patient-Centered Medical Home (PCMH), which has shown great promise in meeting the policy objectives suggested above, should be among the models selected for broader testing on a national pilot basis; the use of the medical home model for treatment or services under private health plans, the requirement of health plans to provide incentives to promote and report on medical home services provided, the establishment of community health teams and a primary care extension program to educate and support primary care practices in the delivery of medical home services, and the establishment of a demonstration project to educate physicians and other clinicians in training in the competencies required to deliver care consistent with the medical home care model. Maternal Health: Advocated for the Preventing Maternal Deaths Act, H.R. 1318, which supports state Maternal Mortality Review Committees, and promotes national information sharing through the Centers for Disease Control and Prevention (CDC), so that states can continue to learn from best practices and collaborate as needed. This bill will also put data to work through demonstration projects to eliminate disparities in maternal health outcomes. Veterans Care: Regarding the VA Mission Act of 2018 (H.R. 5674), the College urged Congress to ensure that veterans have access to timely, contiguous care across the spectrum of health care services, with coordination and management of that care in the hands of a primary clinician or clinical care team; that the expansion of care to non-VHA facilities does not come at the cost of maintaining or improving existing VHA services or infrastructure; and that recruitment and retention of clinicians to the VHA is valued appropriately, including reimbursement for services provided. Non-discrimination Protections: Urged the U.S. Department of Health and Human Services not to weaken nondiscrimination protections for lesbian, gay, bisexual, transgender, and questioning (LGBTQ) individuals under Section 1557 of the Affordable Care Act. Immigration: Voiced support to Congress on the need to pass the Development, Relief, and Education for Alien Minors (DREAM) Act of 2017, H.R. 3440. This legislation would establish a three-step pathway to U.S. citizenship through college, work, or the armed services for individuals who were born in another country and brought illegally to the U.S. at a young age (DREAMers). Clinical Labs: Commented to the Centers for Medicare and Medicaid Services (CMS) on issues pertaining to the Protecting Access to Medicare Act of 2014 (PAMA), specifically citing concerns about the potential impacts of PAMA on patient access to critical rapid clinical testing services offered to patients while they are receiving medical care in their physicians office; expressed further concerns about impending cuts on Jan. 1, 2018 for physician office-based testing services. Expand Coverage and Stabilizing the Insurance Market: Congress should work to help stabilize the individual health insurance market and expand coverage. Specifically by develop and introduce comprehensive market stabilization legislation that includes reinsurance options to help stabilize the markets; Expanding cost-sharing assistance eligibility to purchase insurance in the exchanges as well as increase the level of premium tax credits and cost sharing subsidies offered to purchase a qualified health plan; Introducing legislation that would block the expansion of access to short-term health plans or Association Health Plans that allow insurers to charge more to individuals with pre-existing conditions and permit them to exclude from coverage essential medical care; Supporting $690 million in discretionary funding for federal exchanges within CMS Program Operations as part of the FY2019 Labor, Health and Human Services, and Education Appropriations bill. Reduce Unnecessary Administrative Tasks on Physicians and Patients: Congress should accelerate its efforts to reduce administrative burdens on clinicians and patients, including: Passing the Standardizing Electronic Prior Authorization for Safe Prescribing Act (H.R. 4841), which standardizes electronic prior authorization for prescription drugs under Medicare Part D. Adopt even greater harmonization of such standards across the health care industry; Passing the CONNECTIONS Act (H.R. 5812) by Reps. Griffith (R-VA) and Pallone (D-NJ) that would authorize CDC grants to state-run PDMPs to improve data collection and integration into physician clinical workflow specifically, of controlled substances overdose prevention and surveillance activities; Urging health care committees in Congress with jurisdiction over Medicare to exercise their oversight authority of CMS effort to overhaul clinical documentation guidelines with input from practicing clinicians; Passing the Improving Access to Medicare Coverage Act of 2017 (S. 568/H.R. 1421), which deems patients under observation as inpatients for the purposes of satisfying the Medicare 3-day inpatient stay requirement. Reduce Prescription Drug Costs: Congress should increase transparency and accountability in prescription drug pricing and improve access to lower-cost generic medications by passing the Drug Price Transparency in Communications Act (S. 2157), which would require drug companies to disclose the Wholesale Acquisition Cost of an Rx in Direct-to-Consumer Advertising. Representatives should introduce the companion bill; Passing the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2017 (S. 974/H.R. 2212), which would improve patient access to alternative low-cost prescription drugs and biological products by preventing prescription drug manufacturers from misusing the FDAs Risk Evaluation and Mitigation Strategies (REMS) process to make it difficult for competing generics to be brought to the market; Passing the Medicare Prescription Drug Price Negotiation Act of 2017 (S. 41/H.R. 242), which would grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for high�cost drugs and biologics covered under Part D; Passing the Fair Accountability and Innovative Research (FAIR) Pricing Act (S. 1131/H.R. 2439), which would require drug manufacturers to disclose and provide more information about planned drug price increases, including R&D costs. Fund Workforce, Medical and Health Services Research, Public Health Initiatives: Congress should ensure funding in FY 2019 for federal programs/initiatives designed to support primary care and reject funding rescissions that would harm childrens health coverage or CMS Innovation Center. This includes funding the Primary Care and Training Enhancement (PCTE) at $71 million in order to maintain and expand the pipeline for individuals training in primary care; Funding the National Health Service Corps (NHSC) at least at $415 million in total program funding to fund scholarships and loan repayment to health care professionals to help expand the countrys primary care workforce and meet the health care needs of underserved communities; Funding the Centers for Disease Control and Prevention (CDC) and Prevention and Public Health Fund (PPHF) at $8.45 billion; including PPHF funding at $805 million; Funding the Agency for Healthcare Research and Quality (AHRQ) at $454 million, restoring the agency to its FY2010 enacted level adjusting for inflation after cuts in FY2016 and FY2017 and a small increase in FY2018 so it can help clinicians help patients by making evidence-informed decisions, fund research that serves as the evidence engine for much of the private sectors work to keep patients safe; Funding the National Institutes of Health (NIH) at $39 billion so that this nations biomedical research can continue to fund cures for disease and maintain the U.S. standing as the world leader in medical and biomedical research. Promote Continued Action to Address the Epidemic of Opioid Use: Congress should pass a comprehensive legislative package to improve prevention, education, treatment and recovery for those suffering from opioid-related addictions, including: Providing for sufficient and increased funding to address the opioid epidemic, building and expanding upon the $4.65 billion in the omnibus bill approved by Congress, with at least $1 billion for programs as authorized by CARA 2.0; Expanding access and coverage for medication assisted treatment (methadone, buprenorphine, and naltrexone to prevent opioid and substance use disorders; Rejecting any proposal to impose a three day prescribing limit for initial opioid prescriptions to ensure that doctors have appropriate flexibility to determine the proper duration of each opioid prescription; Passing the Comprehensive Addiction and Recovery Act 2.0 of 2018 (S. 2456/H.R. 5311) as a step toward a more comprehensive opioids-related package. Reduce Firearms-Related Injury and Death: Congress should pass the Assault Weapons Ban of 2018 (S. 2095/H.R. 5077), which would ban the sale of high velocity, rapid file assault rifles and large capacity ammunition magazines and bump stocks; Pass the Brady Background Expansion Act (S. 2009), to expand background checks to virtually all firearm sales in the United States; Pass the Stop Illegal Trafficking in Firearms Act of 2017 (S. 1185), and the Stop Straw Purchases Act (H.R. 5134). Both would increase penalties for individuals who unlawfully purchase firearms for other persons who are prohibited from possessing firearms (known as straw purchasers); Repeal the Dickey amendment restricting firearms-related research by federal agencies and support $50 million in funding for the CDC to conduct such research; Pass S. 834/H.R. 1832 that authorizes funding for the CDC to conduct such research. Make Graduate Medical Education (GME) Funding More Effective: Congress should develop and pass legislation to reform GME to prioritize funding toward physician specialties where millions of patients lack access, including internal medicine specialists trained in comprehensive primary care, to: Increase the number of GME slots by at least 3,000 per year over five years for specialties facing shortages, including internal medicine, as contained in the Resident Physician Shortage Reduction Act of 2017 (S. 1301/H.R. 2267); Combine DGME/IME into a single, more functional program; broaden the GME financing structure to include all payers; Allocate GME funds transparently and to activities that further the educational mission of teaching and training residents/fellows with input from practicing clinicians and in collaboration with their professional organizations; Support continued adequate funding for the VHA and its substantial contributions to the ongoing training of the next generation of physicians.

Client expense: $89,568 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), President of the U.S., SENATE

S 2011/HR 4138-Medicare Drug Price Negotiation Act, S 974/HR 2212-CREATES Act of 2017, S 124-Preserve Access to Affordable Generics Act, HR 1625-OMNIBUS, opioid addiction data analysis, S 771-Improving access to affordable prescription drugs act, S 252-Medicare Drug Savings act of 2017, S 1369-Stop Price Gouging Act, S 495-Medical innovation and prize fund act, S 1131/HR 2439-FAIR drug pricing act, HR 4117-Competitive Drugs act of 2017, S 771/HR 1776-Improving access to affordable prescription drugs act, S 637-C-THRU Act, S 1347-RxCap Act of 2017, S 1348-SPIKE Act of 2017, HR 5156-Protecting Medicare from Excessive Price Increases Act of 2018, S 2691-Opioid Crisis accountability act of 2018, S 2315-Over the counter drug safety, innovation, and reform act, S 2700/HR 5545-Comprehensive Addiction Resources Emergency (CARE) act, Drug Pricing-Medicare Part D HR 2051-FAST Generics Act of 2017, HR 4116-Transparent Drug Pricing Act, S 2852-Pandemic and All-Hazards Preparedness Act and advancing innovative Act of 2018,

Client expense: $70,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)

H.R.1776/ S.771, Improving Access To Affordable Prescription Drugs Act H.R. 2439/ S.1131, Fair Accountability and Innovative Research Drug Pricing Act S.1348, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act H.R.4385, Responsibility in Drug Advertising Act H.R.4116, Transparent Drug Pricing Act S.2157, Drug-Price Transparency in Communications Act S.2478, End Taxpayer Subsidies for Drug Ads Act FTC Reauthorization Act of 2018 (Not introduced)

Client expense: Not reported · Firm income: $210,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE