Co-Prescribing Saves Lives Act of 2016

Preserving 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; Training more primary care physicians through the National Health Service Corps, Title VII health professions funding, and redistributing unused graduate medical education positions to primary care specialties facing shortages; Beginning in 2014, ensuring that nearly all Americans have access to coverage either through subsidized private health insurance offered by state health exchanges or through Medicaid, if they don't already have access to coverage through an employer, Medicare, or another public program; voiced strong opposition to the American Health Care Act/Better Care Reconciliation Act/Graham-Cassidy proposal because these bills would cap the federal contribution to Medicaid or block grant the program, end support for Medicaid expansion, allow state waivers to eliminate essential evidence-based benefits, cut funding for opioid use treatment, restrict access to womens health services, and replace the Affordable Care Acts income-based premium and cost-saving subsidies with regressive age-based ones that will raise premiums and deductibles for most Americans, especially, for older, poorer and sicker patients. 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 in 2019; proposing specific alternatives to CMS Advancing Care Information program that is to replace the current Meaningful Use program; proposing additional improvements to simplify the reporting requirements for the Quality, Advancing Care Information and Clinical Practice Improvement 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; that CMS use its authority to adjust resource use down from 10 percent in the first performance period by setting resource use at zero and increasing the quality performance category by 10 percent to make up for the difference; that CMS ensures the utmost transparency in how the Agency attributes cost, based on the use of the patient relationship categories and codes, along with the codes for care episodes and patient conditions; that CMS allow all Accountable Care Organizations (ACOs) to be eligible to participate in Track 1+ and to not restrict participation based on ACO size or composition (ex. only physician-led ACOs or small ACOs); that CMS allow current ACOs to move into Track 1+ at the start of any performance year and not be required to wait until the beginning of their next three-year agreement period; that Track 1+ utilize the same benchmarking methodology used for the other MSSP tracks; that CMS implement a minimum threshold of 5,000 beneficiaries for Track 1+, which is consistent with the other MSSP tracks but is lower than the 10,000 (or 7,500 for rural ACOs) beneficiary threshold used in the Next Generation ACO model. Medical Education: Provide incentives to medical schools, community health centers, or hospitals, to increase the numbers of physicians choosing primary care; authorize HHS to selectively eliminate Graduate Medical Education (GME) caps for residency programs in primary care, advocated for S. 1627, which would increase the number of Medicare-supported training positions for medical residents by 15 percent (approximately 15,000 slots) over five years, requiring at least 50 percent of the new positions to be allocated to specialties facing a current shortage; Advocated to protect Medicare beneficiary access to health care services by preserving existing Medicare financing for Graduate Medical Education (GME). In the 114th Congress, advocated for S.1148/H.R.2124 and H.R. 1117-to strategically increase the number of GME training positions in primary care specialties (including internal medicine) and other specialties facing shortages. Urged lawmakers to combine DGME and IME into a single, more functional payment program, and broaden the GME financing structure to include all payers; Allocate GME funds transparently and specifically to activities that further the educational mission of teaching and training residents and fellows with input from practicing clinicians and in collaboration with their professional organizations. FY2018 Appropriations: Supported funding to "improve health care quality, enhance consumer choice, advance patient safety, improve efficiency, reduce medical errors, and broaden access to essential services; Advocated for funding for AHRQ and Patient Centered Outcome Research Trust Fund, the Health Resources and Services Administration (HRSA); Title VII, Section 747, Primary Care Training and Enhancement; National Health Service Corps. Also, advocated for the reauthorization of critical workforce programs that expired on Sept. 30, 2017 including, Community Health Centers, the Teaching Health Center Graduate Medical Education program, the National Health Services Corps, and expiring on Dec. 8th, the Title VII Health Professions programs. Public Health Programs and Funding: Increase funding to accomplish the core missions and activities of the major federal public health agencies, including: biomedical and behavioral research, disease prevention and health promotion, access to safety net health care services, health professions education, mental health and substance abuse, health services research, health care for American Indians and Alaska natives, food and drug safety. Improving Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Ensure that all Americans will have access to affordable coverage. 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. Regarding the Essential Health Benefits Bulletin, issued by the Department of Health and Human Services (HHS) on December 16, 2011, the College advocated for striking a balance between comprehensiveness and affordability while giving States some freedom to determine a package that best serve the needs of residents. 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. Advocated to repeal the mandate that requires a prescription for over-the-counter medications purchased through a Health Savings Account. Advocated for legislation that would provide coverage under Medicare for voluntary consultations between doctors and patients to discuss advance care plans, as included in H.R. 1173, the Personalize Your Care Act; advocated in Aug. 2014 for the Medicare Advantage Participants Bill of Rights, H.R. 4998 and S. 2552, that would prevent Medicare Advantage plans from terminating physicians from Medicare Advantage plan networks without sufficient notice or cause. 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 establishing of a new CMS Innovation Center to pilot-test new payment models, such as the medical home; 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. National workforce policy to ensure sufficient numbers of primary care and other physicians: Increase funding for scholarships and loan repayment programs under Title VII as well as increase funding for the National Health Service Corps (NHSC); Provide new practice-entry bonus for scholarship or loan repayment award recipients who remain in underserved communities after completion of service obligation. Reducing Administrative Burdens on Physicians: Urged Congress to reduce administrative tasks that negatively impact physicians and patients, including: 1)Encourage the administration to convene a multi-agency task force to identify tasks that could be streamlined or eliminated, based on a new comprehensive framework to assess the intent and impact of administrative tasks on care as proposed in ACPs policy paper, Putting Patients First by Reducing Administrative Tasks in Health Care, 2) Establish a process to require that CMS and other relevant federal agencies reexamine and replace the existing E/M documentation guidelines with input from practicing clinicians and their professional organizations, 3) Call on federal advisory bodies, such as the Medicare Payment Advisory Commission (MedPAC), to research the effect of administrative tasks on patient and family care experience and outcomes, 4) Facilitate congressional hearings among government, clinician stakeholders, EHR vendors and suppliers to foster collaboration between parties to recognize their role and responsibility in reducing health IT administrative burdens. Opioid Abuse: ACP supports efforts in trying to improve access to care and treatment for those suffering from mental health and substance abuse disorders. As contained in S. 2256, Co-Prescribing Saves Lives Act of 2015, ACP supports a comprehensive national policy on prescription drug abuse containing education, monitoring, proper disposal, and enforcement elements. As contained in S. 2256, Co-Prescribing Saves Lives Act of 2015, ACP is supportive of expanding access to naloxone within the community. ACP also supports the policy proposal known as partial-fill. This would allow a patient to elect to receive a portion of a prescription, and return for either a portion of, or the remainder of the prescription, if the pain persists, up to a 30-day maximum. Urged lawmakers to include language in the final House opioids legislative package to ensure healthcare providers who are engaged in population health initiatives have access to the medical records they need, including information on substance use disorders, to effectively and safely treat their patients; Urged lawmakers to reach agreement on a final conference report to the Comprehensive Addiction and Recovery Act (CARA) that would include: Development of a federal interagency task force to review, modify, and update, as appropriate, best practices for pain management and prescribing pain medication; Grants to states to expand awareness and education of physicians, patients, health care providers regarding the risks associated with the misuse of opioids; A comprehensive Prescription Drug Monitoring Program (PDMP) to track the dispensing of controlled substances; Increased availability of opioid overdose reversal drugs; Alternatives to incarceration to individuals who misuse opioid drugs and other substances to manage their pain. Zika: ACP urged lawmakers to pass legislation that would provide the highest possible funding level for research, prevention, control, and treatment of illnesses associated with the Zika virus that is commensurate with the public health emergency that the virus represents. Prescription Drugs: ACP advocated support for lawmakers efforts in preventing some brand-name drug-companies from using statutorily required Food and Drug Administration (FDA) risk and safety programs to stifle other companies development of generic and biosimilar versions of brand-name drugs, specifically through introduction of the CREATES Act. Urged lawmakers to increase transparency in drug pricing by requiring pharmaceutical manufacturers to publically disclose production costs including research and development investments for specific high�cost drugs that the Secretary identifies through regulation; Authorize and appropriate $2.74 billion in discretionary spending for the FDA to expedite, through fast-track approval, new drugs that address unmet medical need in the treatment of a serious or life threatening condition, as well as to address the back-log of pending generic drug applications; Grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for prescription drugs covered under Part D of the Medicare program. Expressed support for S. 41, the Medicare Prescription Drug Price Negotiation Act that will empower the Secretary of Health and Human Services to negotiate with pharmaceutical manufacturers the prices (including discounts, rebates, and other price concessions) that may be charged for prescription drugs covered under Medicare Part D in prescription drug plans that participate in this program; Supported provisions in the FDA Reauthorization Act that provide goal dates for all outstanding generic applications; establishment of priority review timelines for generic drugs; and efforts to continue building the biosimilars review program. Medical Liability Reform: Expressed support for H.R. 1215, the Protecting Access to Care Act of 2017, which would set a federal limit on the amount of non-economic damages to $250,000 and would enact a fair share rule that specifies that in any health care lawsuit, each party shall be liable for that partys share of damages only and not for the share of any other person. It would specify that any state law that imposes different standards on non-economic damages or separate limits on a partys share of damages would supersede any new caps imposed by this legislation regardless of whether the amount imposed by the states is greater or less than those imposed by H.R. 1215; Supported legislation that allows physicians who document adherence to certain evidence-based clinical-practice guidelines and, when applicable, appropriate use criteria, a safe harbor from medical malpractice litigation, as proposed by the Saving Lives, Saving Cost Act, H.R. 1565. Chronic Care Management: Urged lawmakers to eliminate the beneficiary co-pay for chronic care management (CCM) services, require reimbursement and coverage of additional codes for more complex CCM services, direct HHS to authorize payment for CCM codes to allow physicians to spend up to 40 minutes with a patient and an additional code that would allow for 60 minutes of treatment for a patient with multiple chronic illnesses; Advocated for passage of The Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act, S. 870, which would expand the use of tele-health for individuals with stroke, provide flexibility for Medicare beneficiaries to be part of an Accountable Care Organization, extend the Independence at Home model of care. Telemedicine: Urged lawmakers to broadly lift geographic restrictions on telemedicine, facilitate the use of such telehealth services in stroke treatment, and incorporate the use of these services into ACOs, cosponsor bipartisan legislation, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) For Health Act (the CONNECT For Health Act), H.R. 4442/S. 2484, which would expand the use of telemedicine and remote patient monitoring (RPM) services by physicians to improve care of patients enrolled in Medicare. Mental Health: Urged lawmakers to establish grants, including Innovation and Demonstration grants, to State and local governments, educational institutions, and nonprofit organizations for integrating or coordinating physical health, mental health and substance abuse services; Provide a defined portion of grant funding to the effective integration of services to address mental illness and substance abuse within the primary care setting and to expand a workforce trained to integrate behavioral health within the primary care setting. Childrens Health: Advocated for a 5-year extension of the Childrens Health Insurance Program (CHIP), which expired on Sept. 30, 2017, on the basis of it serving as the key health insurance safety net program for children of low-income families. Insurance Market Stabilization: Commented on the Centers for Medicare and Medicaid Services (CMS) Proposed Rule: Patient Protection and Affordable Care Act; Market Stabilization. Specifically, the Agency should not allow issuers to deny coverage enrollees with bad debt; instead, the issuer should be required to enroll the individual and allow the enrollee to pay the outstanding debt over a period of time; recommended that the open enrollment period for plan year 2018 begin on November 1, 2017 and end on January 31, 2018; States operating a state-based, state-based/federal platform, and partnership marketplaces should be permitted to establish longer open enrollment periods; Expressed concern about the proliferation of narrow provider networks, that tight provider networks coupled with inaccurate provider directories create a frustrating, confusing and expensive experience for patients seeking care from their preferred physicians. Advocated to the Senate Health, Education, Labor and Pensions (HELP) Committee on the need to stabilize the health insurance market, including the need to fund cost-sharing reduction (CSRs) payments for 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. Medicare Physician Fee Schedule: Commented to CMS on the CY2018 proposed rule on the Physician Fee Schedule, including: any revisions made to the E/M documentation guidelines should not result in a revaluation of the entire E/M code set; all relevant stakeholders, including medical specialty organizations, should work with both the Current Procedural Terminology (CPT) Editorial Panel and CMS to create frameworks outlining general principles of care that are beneficial and appropriate for medical specialties in describing the varying approaches to patient care for the current levels of E/M codes.

Client expense: $93,777 · 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

Preserving 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; Training more primary care physicians through the National Health Service Corps, Title VII health professions funding, and redistributing unused graduate medical education positions to primary care specialties facing shortages; Beginning in 2014, ensuring that nearly all Americans have access to coverage either through subsidized private health insurance offered by state health exchanges or through Medicaid, if they don't already have access to coverage through an employer, Medicare, or another public program; voiced strong opposition to the American Health Care Act/Better Care Reconciliation Act because this legislation would cap the federal contribution to Medicaid or block grant the program, end support for Medicaid expansion, allow state waivers to eliminate essential evidence-based benefits, cut funding for opioid use treatment, restrict access to womens health services, and replace the Affordable Care Acts income-based premium and cost-saving subsidies with regressive age-based ones that will raise premiums and deductibles for most Americans, especially, for older, poorer and sicker patients. 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 in 2019; proposing specific alternatives to CMS Advancing Care Information program that is to replace the current Meaningful Use program; proposing additional improvements to simplify the reporting requirements for the Quality, Advancing Care Information and Clinical Practice Improvement 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; that CMS use its authority to adjust resource use down from 10 percent in the first performance period by setting resource use at zero and increasing the quality performance category by 10 percent to make up for the difference; that CMS ensures the utmost transparency in how the Agency attributes cost, based on the use of the patient relationship categories and codes, along with the codes for care episodes and patient conditions; that CMS allow all Accountable Care Organizations (ACOs) to be eligible to participate in Track 1+ and to not restrict participation based on ACO size or composition (ex. only physician-led ACOs or small ACOs); that CMS allow current ACOs to move into Track 1+ at the start of any performance year and not be required to wait until the beginning of their next three-year agreement period; that Track 1+ utilize the same benchmarking methodology used for the other MSSP tracks; that CMS implement a minimum threshold of 5,000 beneficiaries for Track 1+, which is consistent with the other MSSP tracks but is lower than the 10,000 (or 7,500 for rural ACOs) beneficiary threshold used in the Next Generation ACO model. Medical Education: Provide incentives to medical schools, community health centers, or hospitals, to increase the numbers of physicians choosing primary care; authorize HHS to selectively eliminate Graduate Medical Education (GME) caps for residency programs in primary care, advocated for S. 1627, which would increase the number of Medicare-supported training positions for medical residents by 15 percent (approximately 15,000 slots) over five years, requiring at least 50 percent of the new positions to be allocated to specialties facing a current shortage; Advocated to protect Medicare beneficiary access to health care services by preserving existing Medicare financing for Graduate Medical Education (GME). In the 114th Congress, advocated for S.1148/H.R.2124 and H.R. 1117-to strategically increase the number of GME training positions in primary care specialties (including internal medicine) and other specialties facing shortages. Urged lawmakers to combine DGME and IME into a single, more functional payment program, and broaden the GME financing structure to include all payers; Allocate GME funds transparently and specifically to activities that further the educational mission of teaching and training residents and fellows with input from practicing clinicians and in collaboration with their professional organizations. FY2018 Appropriations: Supported funding to "improve health care quality, enhance consumer choice, advance patient safety, improve efficiency, reduce medical errors, and broaden access to essential services; Advocated for funding for AHRQ and Patient Centered Outcome Research Trust Fund, the Health Resources and Services Administration (HRSA); Title VII, Section 747, Primary Care Training and Enhancement; National Health Service Corps. Public Health Programs and Funding: Increase funding to accomplish the core missions and activities of the major federal public health agencies, including: biomedical and behavioral research, disease prevention and health promotion, access to safety net health care services, health professions education, mental health and substance abuse, health services research, health care for American Indians and Alaska natives, food and drug safety. Improving Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Ensure that all Americans will have access to affordable coverage. 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. Regarding the Essential Health Benefits Bulletin, issued by the Department of Health and Human Services (HHS) on December 16, 2011, the College advocated for striking a balance between comprehensiveness and affordability while giving States some freedom to determine a package that best serve the needs of residents. 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. Advocated to repeal the mandate that requires a prescription for over-the-counter medications purchased through a Health Savings Account. Advocated for legislation that would provide coverage under Medicare for voluntary consultations between doctors and patients to discuss advance care plans, as included in H.R. 1173, the Personalize Your Care Act of 2013; advocated in Aug. 2014 for the Medicare Advantage Participants Bill of Rights, H.R. 4998 and S. 2552, that would prevent Medicare Advantage plans from terminating physicians from Medicare Advantage plan networks without sufficient notice or cause. 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 premium subsidies in the event that the Supreme Court rules in favor of the petitioners in the King versus Burwell case. Congress should not make changes in the ACA that would result in more uninsured persons or weaken consumer protections. 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 establishing of a new CMS Innovation Center to pilot-test new payment models, such as the medical home; 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. National workforce policy to ensure sufficient numbers of primary care and other physicians: Increase funding for scholarships and loan repayment programs under Title VII as well as increase funding for the National Health Service Corps (NHSC); Provide new practice-entry bonus for scholarship or loan repayment award recipients who remain in underserved communities after completion of service obligation. Reducing Administrative Burdens on Physicians: Urged Congress to reduce administrative tasks that negatively impact physicians and patients, including: 1)Encourage the administration to convene a multi-agency task force to identify tasks that could be streamlined or eliminated, based on a new comprehensive framework to assess the intent and impact of administrative tasks on care as proposed in ACPs policy paper, Putting Patients First by Reducing Administrative Tasks in Health Care, 2) Establish a process to require that CMS and other relevant federal agencies reexamine and replace the existing E/M documentation guidelines with input from practicing clinicians and their professional organizations, 3) Call on federal advisory bodies, such as the Medicare Payment Advisory Commission (MedPAC), to research the effect of administrative tasks on patient and family care experience and outcomes, 4) Facilitate congressional hearings among government, clinician stakeholders, EHR vendors and suppliers to foster collaboration between parties to recognize their role and responsibility in reducing health IT administrative burdens. Opioid Abuse: ACP supports efforts in trying to improve access to care and treatment for those suffering from mental health and substance abuse disorders. As contained in S. 2256, Co-Prescribing Saves Lives Act of 2015, ACP supports a comprehensive national policy on prescription drug abuse containing education, monitoring, proper disposal, and enforcement elements. As contained in S. 2256, Co-Prescribing Saves Lives Act of 2015, ACP is supportive of expanding access to naloxone within the community. ACP also supports the policy proposal known as partial-fill. This would allow a patient to elect to receive a portion of a prescription, and return for either a portion of, or the remainder of the prescription, if the pain persists, up to a 30-day maximum. Urged lawmakers to include language in the final House opioids legislative package to ensure healthcare providers who are engaged in population health initiatives have access to the medical records they need, including information on substance use disorders, to effectively and safely treat their patients; Urged lawmakers to reach agreement on a final conference report to the Comprehensive Addiction and Recovery Act (CARA) that would include: Development of a federal interagency task force to review, modify, and update, as appropriate, best practices for pain management and prescribing pain medication; Grants to states to expand awareness and education of physicians, patients, health care providers regarding the risks associated with the misuse of opioids; A comprehensive Prescription Drug Monitoring Program (PDMP) to track the dispensing of controlled substances; Increased availability of opioid overdose reversal drugs; Alternatives to incarceration to individuals who misuse opioid drugs and other substances to manage their pain. Zika: ACP urged lawmakers to pass legislation that would provide the highest possible funding level for research, prevention, control, and treatment of illnesses associated with the Zika virus that is commensurate with the public health emergency that the virus represents. Prescription Drugs: ACP advocated support for lawmakers efforts in preventing some brand-name drug-companies from using statutorily required Food and Drug Administration (FDA) risk and safety programs to stifle other companies development of generic and biosimilar versions of brand-name drugs, specifically through introduction of the CREATES Act. Urged lawmakers to increase transparency in drug pricing by requiring pharmaceutical manufacturers to publically disclose production costs including research and development investments for specific high�cost drugs that the Secretary identifies through regulation; Authorize and appropriate $2.74 billion in discretionary spending for the FDA to expedite, through fast-track approval, new drugs that address unmet medical need in the treatment of a serious or life threatening condition, as well as to address the back-log of pending generic drug applications; Grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for prescription drugs covered under Part D of the Medicare program. Expressed support for S. 41, the Medicare Prescription Drug Price Negotiation Act that will empower the Secretary of Health and Human Services to negotiate with pharmaceutical manufacturers the prices (including discounts, rebates, and other price concessions) that may be charged for prescription drugs covered under Medicare Part D in prescription drug plans that participate in this program; Supported provisions in the FDA Reauthorization Act that provide goal dates for all outstanding generic applications; establishment of priority review timelines for generic drugs; and efforts to continue building the biosimilars review program. Medical Liability Reform: Expressed support for H.R. 1215, the Protecting Access to Care Act of 2017, which would set a federal limit on the amount of non-economic damages to $250,000 and would enact a fair share rule that specifies that in any health care lawsuit, each party shall be liable for that partys share of damages only and not for the share of any other person. It would specify that any state law that imposes different standards on non-economic damages or separate limits on a partys share of damages would supersede any new caps imposed by this legislation regardless of whether the amount imposed by the states is greater or less than those imposed by H.R. 1215; Supported legislation that allows physicians who document adherence to certain evidence-based clinical-practice guidelines and, when applicable, appropriate use criteria, a safe harbor from medical malpractice litigation, as proposed by the Saving Lives, Saving Cost Act, H.R. 1565. Chronic Care Management: Urged lawmakers to eliminate the beneficiary co-pay for chronic care management (CCM) services, require reimbursement and coverage of additional codes for more complex CCM services, direct HHS to authorize payment for CCM codes to allow physicians to spend up to 40 minutes with a patient and an additional code that would allow for 60 minutes of treatment for a patient with multiple chronic illnesses. Telemedicine: Urged lawmakers to broadly lift geographic restrictions on telemedicine, facilitate the use of such telehealth services in stroke treatment, and incorporate the use of these services into ACOs, cosponsor bipartisan legislation, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) For Health Act (the CONNECT For Health Act), H.R. 4442/S. 2484, which would expand the use of telemedicine and remote patient monitoring (RPM) services by physicians to improve care of patients enrolled in Medicare. Mental Health: Urged lawmakers to establish grants, including Innovation and Demonstration grants, to State and local governments, educational institutions, and nonprofit organizations for integrating or coordinating physical health, mental health and substance abuse services; Provide a defined portion of grant funding to the effective integration of services to address mental illness and substance abuse within the primary care setting and to expand a workforce trained to integrate behavioral health within the primary care setting. 21st Century Cures Act: Advocated with Congress on several elements of the 21st Century Cures Act, comprehensive legislation designed to accelerate the discovery, development, and delivery of new cures and treatments. These elements included: support for moving the health information technology (health IT) ecosystem toward an interoperable health information network, combatting business practices that inhibit the flow of information by establishing authority for the HHS Office of Inspector General to investigate claims of information blocking and assign penalties for activities found to be interfering with the lawful sharing of electronic information, ensuring that health care clinicians are not penalized for the failure of developers of health IT in the case of information blocking, the establishment of hardship exemptions from Meaningful Use and the Merit-Based Incentive Payment System (MIPS) payment adjustments due to the decertification of an electronic health record (EHR) and, a commitment to develop a strategy around reducing regulatory and administrative burdens, improving and increasing access to treatment for patients suffering from mental health and substance use disorders and ensure better understanding and enforcement of mental health parity laws, accelerating the integration of behavioral health into the primary care setting. Insurance Market Stabilization: Commented on the Centers for Medicare and Medicaid Services (CMS) Proposed Rule: Patient Protection and Affordable Care Act; Market Stabilization. Specifically, the Agency should not allow issuers to deny coverage enrollees with bad debt; instead, the issuer should be required to enroll the individual and allow the enrollee to pay the outstanding debt over a period of time; recommended that the open enrollment period for plan year 2018 begin on November 1, 2017 and end on January 31, 2018; States operating a state-based, state-based/federal platform, and partnership marketplaces should be permitted to establish longer open enrollment periods; Expressed concern about the proliferation of narrow provider networks, that tight provider networks coupled with inaccurate provider directories create a frustrating, confusing and expensive experience for patients seeking care from their preferred physicians.

Client expense: $383,105 · 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

Preserving 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; Training more primary care physicians through the National Health Service Corps, Title VII health professions funding, and redistributing unused graduate medical education positions to primary care specialties facing shortages; Beginning in 2014, ensuring that nearly all Americans have access to coverage either through subsidized private health insurance offered by state health exchanges or through Medicaid, if they don't already have access to coverage through an employer, Medicare, or another public program; voiced strong opposition to the American Health Care Act/Better Care Reconciliation Act because this legislation would cap the federal contribution to Medicaid or block grant the program, end support for Medicaid expansion, allow state waivers to eliminate essential evidence-based benefits, cut funding for opioid use treatment, restrict access to womens health services, and replace the Affordable Care Acts income-based premium and cost-saving subsidies with regressive age-based ones that will raise premiums and deductibles for most Americans, especially, for older, poorer and sicker patients. 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 in 2019; proposing specific alternatives to CMS Advancing Care Information program that is to replace the current Meaningful Use program; proposing additional improvements to simplify the reporting requirements for the Quality, Advancing Care Information and Clinical Practice Improvement 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; that CMS use its authority to adjust resource use down from 10 percent in the first performance period by setting resource use at zero and increasing the quality performance category by 10 percent to make up for the difference; that CMS ensures the utmost transparency in how the Agency attributes cost, based on the use of the patient relationship categories and codes, along with the codes for care episodes and patient conditions; that CMS allow all Accountable Care Organizations (ACOs) to be eligible to participate in Track 1+ and to not restrict participation based on ACO size or composition (ex. only physician-led ACOs or small ACOs); that CMS allow current ACOs to move into Track 1+ at the start of any performance year and not be required to wait until the beginning of their next three-year agreement period; that Track 1+ utilize the same benchmarking methodology used for the other MSSP tracks; that CMS implement a minimum threshold of 5,000 beneficiaries for Track 1+, which is consistent with the other MSSP tracks but is lower than the 10,000 (or 7,500 for rural ACOs) beneficiary threshold used in the Next Generation ACO model. Medical Education: Provide incentives to medical schools, community health centers, or hospitals, to increase the numbers of physicians choosing primary care; authorize HHS to selectively eliminate Graduate Medical Education (GME) caps for residency programs in primary care, advocated for S. 1627, which would increase the number of Medicare-supported training positions for medical residents by 15 percent (approximately 15,000 slots) over five years, requiring at least 50 percent of the new positions to be allocated to specialties facing a current shortage; Advocated to protect Medicare beneficiary access to health care services by preserving existing Medicare financing for Graduate Medical Education (GME). In the 114th Congress, advocated for S.1148/H.R.2124 and H.R. 1117-to strategically increase the number of GME training positions in primary care specialties (including internal medicine) and other specialties facing shortages. Urged lawmakers to combine DGME and IME into a single, more functional payment program, and broaden the GME financing structure to include all payers; Allocate GME funds transparently and specifically to activities that further the educational mission of teaching and training residents and fellows with input from practicing clinicians and in collaboration with their professional organizations FY2018 Appropriations: Supported funding to "improve health care quality, enhance consumer choice, advance patient safety, improve efficiency, reduce medical errors, and broaden access to essential services; Advocated for funding for AHRQ and Patient Centered Outcome Research Trust Fund, the Health Resources and Services Administration (HRSA); Title VII, Section 747, Primary Care Training and Enhancement; National Health Service Corps. Public Health Programs and Funding: Increase funding to accomplish the core missions and activities of the major federal public health agencies, including: biomedical and behavioral research, disease prevention and health promotion, access to safety net health care services, health professions education, mental health and substance abuse, health services research, health care for American Indians and Alaska natives, food and drug safety. Improving Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Ensure that all Americans will have access to affordable coverage. 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. Regarding the Essential Health Benefits Bulletin, issued by the Department of Health and Human Services (HHS) on December 16, 2011, the College advocated for striking a balance between comprehensiveness and affordability while giving States some freedom to determine a package that best serve the needs of residents. 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. Advocated to repeal the mandate that requires a prescription for over-the-counter medications purchased through a Health Savings Account. Advocated for legislation that would provide coverage under Medicare for voluntary consultations between doctors and patients to discuss advance care plans, as included in H.R. 1173, the Personalize Your Care Act of 2013; advocated in Aug. 2014 for the Medicare Advantage Participants Bill of Rights, H.R. 4998 and S. 2552, that would prevent Medicare Advantage plans from terminating physicians from Medicare Advantage plan networks without sufficient notice or cause. 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 premium subsidies in the event that the Supreme Court rules in favor of the petitioners in the King versus Burwell case. Congress should not make changes in the ACA that would result in more uninsured persons or weaken consumer protections. 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 establishing of a new CMS Innovation Center to pilot-test new payment models, such as the medical home; 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. National workforce policy to ensure sufficient numbers of primary care and other physicians: Increase funding for scholarships and loan repayment programs under Title VII as well as increase funding for the National Health Service Corps (NHSC); Provide new practice-entry bonus for scholarship or loan repayment award recipients who remain in underserved communities after completion of service obligation. Reducing Administrative Burdens on Physicians: Urged Congress to reduce administrative tasks that negatively impact physicians and patients, including: 1)Encourage the administration to convene a multi-agency task force to identify tasks that could be streamlined or eliminated, based on a new comprehensive framework to assess the intent and impact of administrative tasks on care as proposed in ACPs policy paper, Putting Patients First by Reducing Administrative Tasks in Health Care, 2) Establish a process to require that CMS and other relevant federal agencies reexamine and replace the existing E/M documentation guidelines with input from practicing clinicians and their professional organizations, 3) Call on federal advisory bodies, such as the Medicare Payment Advisory Commission (MedPAC), to research the effect of administrative tasks on patient and family care experience and outcomes, 4) Facilitate congressional hearings among government, clinician stakeholders, EHR vendors and suppliers to foster collaboration between parties to recognize their role and responsibility in reducing health IT administrative burdens. Opioid Abuse: ACP supports efforts in trying to improve access to care and treatment for those suffering from mental health and substance abuse disorders. As contained in S. 2256, Co-Prescribing Saves Lives Act of 2015, ACP supports a comprehensive national policy on prescription drug abuse containing education, monitoring, proper disposal, and enforcement elements. As contained in S. 2256, Co-Prescribing Saves Lives Act of 2015, ACP is supportive of expanding access to naloxone within the community. ACP also supports the policy proposal known as partial-fill. This would allow a patient to elect to receive a portion of a prescription, and return for either a portion of, or the remainder of the prescription, if the pain persists, up to a 30-day maximum. Urged lawmakers to include language in the final House opioids legislative package to ensure healthcare providers who are engaged in population health initiatives have access to the medical records they need, including information on substance use disorders, to effectively and safely treat their patients; Urged lawmakers to reach agreement on a final conference report to the Comprehensive Addiction and Recovery Act (CARA) that would include: Development of a federal interagency task force to review, modify, and update, as appropriate, best practices for pain management and prescribing pain medication; Grants to states to expand awareness and education of physicians, patients, health care providers regarding the risks associated with the misuse of opioids; A comprehensive Prescription Drug Monitoring Program (PDMP) to track the dispensing of controlled substances; Increased availability of opioid overdose reversal drugs; Alternatives to incarceration to individuals who misuse opioid drugs and other substances to manage their pain. Zika: ACP urged lawmakers to pass legislation that would provide the highest possible funding level for research, prevention, control, and treatment of illnesses associated with the Zika virus that is commensurate with the public health emergency that the virus represents. Prescription Drugs: ACP advocated support for lawmakers efforts in preventing some brand-name drug-companies from using statutorily required Food and Drug Administration (FDA) risk and safety programs to stifle other companies development of generic and biosimilar versions of brand-name drugs, specifically through introduction of the CREATES Act. Urged lawmakers to increase transparency in drug pricing by requiring pharmaceutical manufacturers to publically disclose production costs including research and development investments for specific high�cost drugs that the Secretary identifies through regulation; Authorize and appropriate $2.74 billion in discretionary spending for the FDA to expedite, through fast-track approval, new drugs that address unmet medical need in the treatment of a serious or life threatening condition, as well as to address the back-log of pending generic drug applications; Grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for prescription drugs covered under Part D of the Medicare program. Expressed support for S. 41, the Medicare Prescription Drug Price Negotiation Act that will empower the Secretary of Health and Human Services to negotiate with pharmaceutical manufacturers the prices (including discounts, rebates, and other price concessions) that may be charged for prescription drugs covered under Medicare Part D in prescription drug plans that participate in this program; Supported provisions in the FDA Reauthorization Act that provide goal dates for all outstanding generic applications; establishment of priority review timelines for generic drugs; and efforts to continue building the biosimilars review program. Medical Liability Reform: Expressed support for H.R. 1215, the Protecting Access to Care Act of 2017, which would set a federal limit on the amount of non-economic damages to $250,000 and would enact a fair share rule that specifies that in any health care lawsuit, each party shall be liable for that partys share of damages only and not for the share of any other person. It would specify that any state law that imposes different standards on non-economic damages or separate limits on a partys share of damages would supersede any new caps imposed by this legislation regardless of whether the amount imposed by the states is greater or less than those imposed by H.R. 1215; Supported legislation that allows physicians who document adherence to certain evidence-based clinical-practice guidelines and, when applicable, appropriate use criteria, a safe harbor from medical malpractice litigation, as proposed by the Saving Lives, Saving Cost Act, H.R. 1565. Chronic Care Management: Urged lawmakers to eliminate the beneficiary co-pay for chronic care management (CCM) services, require reimbursement and coverage of additional codes for more complex CCM services, direct HHS to authorize payment for CCM codes to allow physicians to spend up to 40 minutes with a patient and an additional code that would allow for 60 minutes of treatment for a patient with multiple chronic illnesses. Telemedicine: Urged lawmakers to broadly lift geographic restrictions on telemedicine, facilitate the use of such telehealth services in stroke treatment, and incorporate the use of these services into ACOs, cosponsor bipartisan legislation, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) For Health Act (the CONNECT For Health Act), H.R. 4442/S. 2484, which would expand the use of telemedicine and remote patient monitoring (RPM) services by physicians to improve care of patients enrolled in Medicare. Mental Health: Urged lawmakers to establish grants, including Innovation and Demonstration grants, to State and local governments, educational institutions, and nonprofit organizations for integrating or coordinating physical health, mental health and substance abuse services; Provide a defined portion of grant funding to the effective integration of services to address mental illness and substance abuse within the primary care setting and to expand a workforce trained to integrate behavioral health within the primary care setting. 21st Century Cures Act: Advocated with Congress on several elements of the 21st Century Cures Act, comprehensive legislation designed to accelerate the discovery, development, and delivery of new cures and treatments. These elements included: support for moving the health information technology (health IT) ecosystem toward an interoperable health information network, combatting business practices that inhibit the flow of information by establishing authority for the HHS Office of Inspector General to investigate claims of information blocking and assign penalties for activities found to be interfering with the lawful sharing of electronic information, ensuring that health care clinicians are not penalized for the failure of developers of health IT in the case of information blocking, the establishment of hardship exemptions from Meaningful Use and the Merit-Based Incentive Payment System (MIPS) payment adjustments due to the decertification of an electronic health record (EHR) and, a commitment to develop a strategy around reducing regulatory and administrative burdens, improving and increasing access to treatment for patients suffering from mental health and substance use disorders and ensure better understanding and enforcement of mental health parity laws, accelerating the integration of behavioral health into the primary care setting. Insurance Market Stabilization: Commented on the Centers for Medicare and Medicaid Services (CMS) Proposed Rule: Patient Protection and Affordable Care Act; Market Stabilization. Specifically, the Agency should not allow issuers to deny coverage enrollees with bad debt; instead, the issuer should be required to enroll the individual and allow the enrollee to pay the outstanding debt over a period of time; recommended that the open enrollment period for plan year 2018 begin on November 1, 2017 and end on January 31, 2018; States operating a state-based, state-based/federal platform, and partnership marketplaces should be permitted to establish longer open enrollment periods; Expressed concern about the proliferation of narrow provider networks, that tight provider networks coupled with inaccurate provider directories create a frustrating, confusing and expensive experience for patients seeking care from their preferred physicians.

Client expense: $86,831 · 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

Preserving 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; Training more primary care physicians through the National Health Service Corps, Title VII health professions funding, and redistributing unused graduate medical education positions to primary care specialties facing shortages; Beginning in 2014, ensuring that nearly all Americans have access to coverage either through subsidized private health insurance offered by state health exchanges or through Medicaid, if they don't already have access to coverage through an employer, Medicare, or another public program; voiced strong opposition to the American Health Care Act in March 2017 because it would cap the federal contribution to Medicaid or block grant the program, end support for Medicaid expansion, repeal essential evidence-based benefits, or replace the Affordable Care Acts income-based premium and cost-saving subsidies with regressive age-based ones that will raise premiums and deductibles for most Americans, especially, for older, poorer and sicker patients. 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 in 2019; proposing specific alternatives to CMS Advancing Care Information program that is to replace the current Meaningful Use program; proposing additional improvements to simplify the reporting requirements for the Quality, Advancing Care Information and Clinical Practice Improvement 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; that CMS use its authority to adjust resource use down from 10 percent in the first performance period by setting resource use at zero and increasing the quality performance category by 10 percent to make up for the difference; that CMS ensures the utmost transparency in how the Agency attributes cost, based on the use of the patient relationship categories and codes, along with the codes for care episodes and patient conditions; that CMS allow all Accountable Care Organizations (ACOs) to be eligible to participate in Track 1+ and to not restrict participation based on ACO size or composition (ex. only physician-led ACOs or small ACOs); that CMS allow current ACOs to move into Track 1+ at the start of any performance year and not be required to wait until the beginning of their next three-year agreement period; that Track 1+ utilize the same benchmarking methodology used for the other MSSP tracks; that CMS implement a minimum threshold of 5,000 beneficiaries for Track 1+, which is consistent with the other MSSP tracks but is lower than the 10,000 (or 7,500 for rural ACOs) beneficiary threshold used in the Next Generation ACO model. Medical Education: Provide incentives to medical schools, community health centers, or hospitals, to increase the numbers of physicians choosing primary care; authorize HHS to selectively eliminate Graduate Medical Education (GME) caps for residency programs in primary care, advocated for S. 1627, which would increase the number of Medicare-supported training positions for medical residents by 15 percent (approximately 15,000 slots) over five years, requiring at least 50 percent of the new positions to be allocated to specialties facing a current shortage; Advocated to protect Medicare beneficiary access to health care services by preserving existing Medicare financing for Graduate Medical Education (GME). In the 114th Congress, advocated for S.1148/H.R.2124 and H.R. 1117-to strategically increase the number of GME training positions in primary care specialties (including internal medicine) and other specialties facing shortages. Urged lawmakers to combine DGME and IME into a single, more functional payment program, and broaden the GME financing structure to include all payers; Allocate GME funds transparently and specifically to activities that further the educational mission of teaching and training residents and fellows with input from practicing clinicians and in collaboration with their professional organizations. FY2017 Appropriations: Supported funding to "improve health care quality, enhance consumer choice, advance patient safety, improve efficiency, reduce medical errors, and broaden access to essential services; Advocated for funding for AHRQ and Patient Centered Outcome Research Trust Fund, the Health Resources and Services Administration (HRSA); Title VII, Section 747, Primary Care Training and Enhancement; National Health Service Corps. Public Health Programs and Funding: Increase funding to accomplish the core missions and activities of the major federal public health agencies, including: biomedical and behavioral research, disease prevention and health promotion, access to safety net health care services, health professions education, mental health and substance abuse, health services research, health care for American Indians and Alaska natives, food and drug safety. Improving Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Ensure that all Americans will have access to affordable coverage. 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. Regarding the Essential Health Benefits Bulletin, issued by the Department of Health and Human Services (HHS) on December 16, 2011, the College advocated for striking a balance between comprehensiveness and affordability while giving States some freedom to determine a package that best serve the needs of residents. 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. Advocated to repeal the mandate that requires a prescription for over-the-counter medications purchased through a Health Savings Account. Advocated for legislation that would provide coverage under Medicare for voluntary consultations between doctors and patients to discuss advance care plans, as included in H.R. 1173, the Personalize Your Care Act of 2013; advocated in Aug. 2014 for the Medicare Advantage Participants Bill of Rights, H.R. 4998 and S. 2552, that would prevent Medicare Advantage plans from terminating physicians from Medicare Advantage plan networks without sufficient notice or cause. 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 premium subsidies in the event that the Supreme Court rules in favor of the petitioners in the King versus Burwell case. Congress should not make changes in the ACA that would result in more uninsured persons or weaken consumer protections. 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 establishing of a new CMS Innovation Center to pilot-test new payment models, such as the medical home; 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. National workforce policy to ensure sufficient numbers of primary care and other physicians: Increase funding for scholarships and loan repayment programs under Title VII as well as increase funding for the National Health Service Corps (NHSC); Provide new practice-entry bonus for scholarship or loan repayment award recipients who remain in underserved communities after completion of service obligation. Health Information Technology: Commented to HHS Office of the National Coordinator for Health Information Technologys (ONCs) Draft 2017 Interoperability Standards Advisory (ISA), recommending that ONC focus its efforts to identify, repair, and mitigate the negative effects of rapidly spreading bad data; rather than requiring EHRs and other clinical health IT to support multiple separate standards for extracting data for quality, public health, research, payment, and other reporting purposes, ONC should commission development of a single application programming interface (API) for all of the query and data extraction requirements. Urged lawmakers to require the Office of the National Coordinator (ONC) to develop and implement national EHR interoperability standards with direct input from practicing clinicians on the necessary data elements for care delivery, quality improvement and reporting, including the need for a narrative that provides the context of the care needed; Exempt clinicians in small/medium-sized practices from unfunded mandates that require them to purchase health IT software, services or infrastructure to support data exchanges with little or no clinical value, as determined by the Secretary with input from practicing physicians. Opioid Abuse: ACP supports efforts in trying to improve access to care and treatment for those suffering from mental health and substance abuse disorders. As contained in S. 2256, Co-Prescribing Saves Lives Act of 2015, ACP supports a comprehensive national policy on prescription drug abuse containing education, monitoring, proper disposal, and enforcement elements. As contained in S. 2256, Co-Prescribing Saves Lives Act of 2015, ACP is supportive of expanding access to naloxone within the community. ACP also supports the policy proposal known as partial-fill. This would allow a patient to elect to receive a portion of a prescription, and return for either a portion of, or the remainder of the prescription, if the pain persists, up to a 30-day maximum. Urged lawmakers to include language in the final House opioids legislative package to ensure healthcare providers who are engaged in population health initiatives have access to the medical records they need, including information on substance use disorders, to effectively and safely treat their patients; Urged lawmakers to reach agreement on a final conference report to the Comprehensive Addiction and Recovery Act (CARA) that would include: Development of a federal interagency task force to review, modify, and update, as appropriate, best practices for pain management and prescribing pain medication; Grants to states to expand awareness and education of physicians, patients, health care providers regarding the risks associated with the misuse of opioids; A comprehensive Prescription Drug Monitoring Program (PDMP) to track the dispensing of controlled substances; Increased availability of opioid overdose reversal drugs; Alternatives to incarceration to individuals who misuse opioid drugs and other substances to manage their pain. Zika: ACP urged lawmakers to pass legislation that would provide the highest possible funding level for research, prevention, control, and treatment of illnesses associated with the Zika virus that is commensurate with the public health emergency that the virus represents. Prescription Drugs: ACP advocated support for lawmakers efforts in preventing some brand-name drug-companies from using statutorily required Food and Drug Administration (FDA) risk and safety programs to stifle other companies development of generic and biosimilar versions of brand-name drugs, specifically through introduction of the CREATES Act. Urged lawmakers to increase transparency in drug pricing by requiring pharmaceutical manufacturers to publically disclose production costs including research and development investments for specific high�cost drugs that the Secretary identifies through regulation; Authorize and appropriate $2.74 billion in discretionary spending for the FDA to expedite, through fast-track approval, new drugs that address unmet medical need in the treatment of a serious or life threatening condition, as well as to address the back-log of pending generic drug applications; Grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for prescription drugs covered under Part D of the Medicare program. Expressed support for S. 41, the Medicare Prescription Drug Price Negotiation Act that will empower the Secretary of Health and Human Services to negotiate with pharmaceutical manufacturers the prices (including discounts, rebates, and other price concessions) that may be charged for prescription drugs covered under Medicare Part D in prescription drug plans that participate in this program. Medical Liability Reform: Expressed support for H.R. 1215, the Protecting Access to Care Act of 2017, which would set a federal limit on the amount of non-economic damages to $250,000 and would enact a fair share rule that specifies that in any health care lawsuit, each party shall be liable for that partys share of damages only and not for the share of any other person. It would specify that any state law that imposes different standards on non-economic damages or separate limits on a partys share of damages would supersede any new caps imposed by this legislation regardless of whether the amount imposed by the states is greater or less than those imposed by H.R. 1215. Chronic Care Management: Urged lawmakers to eliminate the beneficiary co-pay for chronic care management (CCM) services, require reimbursement and coverage of additional codes for more complex CCM services, direct HHS to authorize payment for CCM codes to allow physicians to spend up to 40 minutes with a patient and an additional code that would allow for 60 minutes of treatment for a patient with multiple chronic illnesses. Telemedicine: Urged lawmakers to broadly lift geographic restrictions on telemedicine, facilitate the use of such telehealth services in stroke treatment, and incorporate the use of these services into ACOs, cosponsor bipartisan legislation, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) For Health Act (the CONNECT For Health Act), H.R. 4442/S. 2484, which would expand the use of telemedicine and remote patient monitoring (RPM) services by physicians to improve care of patients enrolled in Medicare. Mental Health: Urged lawmakers to establish grants, including Innovation and Demonstration grants, to State and local governments, educational institutions, and nonprofit organizations for integrating or coordinating physical health, mental health and substance abuse services; Provide a defined portion of grant funding to the effective integration of services to address mental illness and substance abuse within the primary care setting and to expand a workforce trained to integrate behavioral health within the primary care setting. 21st Century Cures Act: Advocated with Congress on several elements of the 21st Century Cures Act, comprehensive legislation designed to accelerate the discovery, development, and delivery of new cures and treatments. These elements included: support for moving the health information technology (health IT) ecosystem toward an interoperable health information network, combatting business practices that inhibit the flow of information by establishing authority for the HHS Office of Inspector General to investigate claims of information blocking and assign penalties for activities found to be interfering with the lawful sharing of electronic information, ensuring that health care clinicians are not penalized for the failure of developers of health IT in the case of information blocking, the establishment of hardship exemptions from Meaningful Use and the Merit-Based Incentive Payment System (MIPS) payment adjustments due to the decertification of an electronic health record (EHR) and, a commitment to develop a strategy around reducing regulatory and administrative burdens, improving and increasing access to treatment for patients suffering from mental health and substance use disorders and ensure better understanding and enforcement of mental health parity laws, accelerating the integration of behavioral health into the primary care setting. Vaccines: Expressed strong support to the President for the safety of vaccines; Claims that vaccines are unsafe when administered according to expert recommendations have been disproven by a robust body of medical literature, including a thorough review by the National Academy of Medicine (formerly known as the Institute of Medicine). Immigration (Health): Expressed concern that the executive order signed by President Trump on January 27, 2017 will result in discrimination against foreign-born persons from certain predominantly Muslim countries; that by restricting entry of physicians and medical students from seven designated Muslim majority countries, the order will undermine medical education and result in patients losing access to their doctors; that the 120 day ban on accepting refugees, and the indefinite ban on Syrian refugees, will contribute to an ongoing public health crisis for those affected, needlessly subjecting them to violence, injury, illness, deprivation and even death. Expressed support for S. 128, the Bar Removal of Individuals who Dream and Grow our Economy Act (BRIDGE Act), which would allow people who are eligible for or who have received work authorization and temporary relief from deportation through the Deferred Action for Childhood Arrivals (DACA) program to continue living in the U.S. with permission from the federal government for three years after the date of enactment of this legislation. Insurance Market Stabilization: Commented on the Centers for Medicare and Medicaid Services (CMS) Proposed Rule: Patient Protection and Affordable Care Act; Market Stabilization. Specifically, the Agency should not allow issuers to deny coverage enrollees with bad debt; instead, the issuer should be required to enroll the individual and allow the enrollee to pay the outstanding debt over a period of time; recommended that the open enrollment period for plan year 2018 begin on November 1, 2017 and end on January 31, 2018; States operating a state-based, state-based/federal platform, and partnership marketplaces should be permitted to establish longer open enrollment periods; Expressed concern about the proliferation of narrow provider networks, that tight provider networks coupled with inaccurate provider directories create a frustrating, confusing and expensive experience for patients seeking care from their preferred physicians.

Client expense: $243,969 · 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

Preserving 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; Training more primary care physicians through the National Health Service Corps, Title VII health professions funding, and redistributing unused graduate medical education positions to primary care specialties facing shortages; Beginning in 2014, ensuring that nearly all Americans have access to coverage either through subsidized private health insurance offered by state health exchanges or through Medicaid, if they don't already have access to coverage through an employer, Medicare, or another public program; voiced strong opposition to the American Health Care Act in March 2017 because it would cap the federal contribution to Medicaid or block grant the program, end support for Medicaid expansion, repeal essential evidence-based benefits, or replace the Affordable Care Acts income-based premium and cost-saving subsidies with regressive age-based ones that will raise premiums and deductibles for most Americans, especially, for older, poorer and sicker patients. 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 in 2019; proposing specific alternatives to CMS Advancing Care Information program that is to replace the current Meaningful Use program; proposing additional improvements to simplify the reporting requirements for the Quality, Advancing Care Information and Clinical Practice Improvement 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; that CMS use its authority to adjust resource use down from 10 percent in the first performance period by setting resource use at zero and increasing the quality performance category by 10 percent to make up for the difference; that CMS ensures the utmost transparency in how the Agency attributes cost, based on the use of the patient relationship categories and codes, along with the codes for care episodes and patient conditions; that CMS allow all Accountable Care Organizations (ACOs) to be eligible to participate in Track 1+ and to not restrict participation based on ACO size or composition (ex. only physician-led ACOs or small ACOs); that CMS allow current ACOs to move into Track 1+ at the start of any performance year and not be required to wait until the beginning of their next three-year agreement period; that Track 1+ utilize the same benchmarking methodology used for the other MSSP tracks; that CMS implement a minimum threshold of 5,000 beneficiaries for Track 1+, which is consistent with the other MSSP tracks but is lower than the 10,000 (or 7,500 for rural ACOs) beneficiary threshold used in the Next Generation ACO model. Medical Education: Provide incentives to medical schools, community health centers, or hospitals, to increase the numbers of physicians choosing primary care; authorize HHS to selectively eliminate Graduate Medical Education (GME) caps for residency programs in primary care, advocated for S. 1627, which would increase the number of Medicare-supported training positions for medical residents by 15 percent (approximately 15,000 slots) over five years, requiring at least 50 percent of the new positions to be allocated to specialties facing a current shortage; Advocated to protect Medicare beneficiary access to health care services by preserving existing Medicare financing for Graduate Medical Education (GME). In the 114th Congress, advocated for S.1148/H.R.2124 and H.R. 1117-to strategically increase the number of GME training positions in primary care specialties (including internal medicine) and other specialties facing shortages. Urged lawmakers to combine DGME and IME into a single, more functional payment program, and broaden the GME financing structure to include all payers; Allocate GME funds transparently and specifically to activities that further the educational mission of teaching and training residents and fellows with input from practicing clinicians and in collaboration with their professional organizations. FY2017 Appropriations: Supported funding to "improve health care quality, enhance consumer choice, advance patient safety, improve efficiency, reduce medical errors, and broaden access to essential services; Advocated for funding for AHRQ and Patient Centered Outcome Research Trust Fund, the Health Resources and Services Administration (HRSA); Title VII, Section 747, Primary Care Training and Enhancement; National Health Service Corps. Public Health Programs and Funding: Increase funding to accomplish the core missions and activities of the major federal public health agencies, including: biomedical and behavioral research, disease prevention and health promotion, access to safety net health care services, health professions education, mental health and substance abuse, health services research, health care for American Indians and Alaska natives, food and drug safety. Improving Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Ensure that all Americans will have access to affordable coverage. 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. Regarding the Essential Health Benefits Bulletin, issued by the Department of Health and Human Services (HHS) on December 16, 2011, the College advocated for striking a balance between comprehensiveness and affordability while giving States some freedom to determine a package that best serve the needs of residents. 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. Advocated to repeal the mandate that requires a prescription for over-the-counter medications purchased through a Health Savings Account. Advocated for legislation that would provide coverage under Medicare for voluntary consultations between doctors and patients to discuss advance care plans, as included in H.R. 1173, the Personalize Your Care Act of 2013; advocated in Aug. 2014 for the Medicare Advantage Participants Bill of Rights, H.R. 4998 and S. 2552, that would prevent Medicare Advantage plans from terminating physicians from Medicare Advantage plan networks without sufficient notice or cause. 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 premium subsidies in the event that the Supreme Court rules in favor of the petitioners in the King versus Burwell case. Congress should not make changes in the ACA that would result in more uninsured persons or weaken consumer protections. 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 establishing of a new CMS Innovation Center to pilot-test new payment models, such as the medical home; 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. National workforce policy to ensure sufficient numbers of primary care and other physicians: Increase funding for scholarships and loan repayment programs under Title VII as well as increase funding for the National Health Service Corps (NHSC); Provide new practice-entry bonus for scholarship or loan repayment award recipients who remain in underserved communities after completion of service obligation. Health Information Technology: Commented to HHS Office of the National Coordinator for Health Information Technologys (ONCs) Draft 2017 Interoperability Standards Advisory (ISA), recommending that ONC focus its efforts to identify, repair, and mitigate the negative effects of rapidly spreading bad data; rather than requiring EHRs and other clinical health IT to support multiple separate standards for extracting data for quality, public health, research, payment, and other reporting purposes, ONC should commission development of a single application programming interface (API) for all of the query and data extraction requirements. Urged lawmakers to require the Office of the National Coordinator (ONC) to develop and implement national EHR interoperability standards with direct input from practicing clinicians on the necessary data elements for care delivery, quality improvement and reporting, including the need for a narrative that provides the context of the care needed; Exempt clinicians in small/medium-sized practices from unfunded mandates that require them to purchase health IT software, services or infrastructure to support data exchanges with little or no clinical value, as determined by the Secretary with input from practicing physicians. Opioid Abuse: ACP supports efforts in trying to improve access to care and treatment for those suffering from mental health and substance abuse disorders. As contained in S. 2256, Co-Prescribing Saves Lives Act of 2015, ACP supports a comprehensive national policy on prescription drug abuse containing education, monitoring, proper disposal, and enforcement elements. As contained in S. 2256, Co-Prescribing Saves Lives Act of 2015, ACP is supportive of expanding access to naloxone within the community. ACP also supports the policy proposal known as partial-fill. This would allow a patient to elect to receive a portion of a prescription, and return for either a portion of, or the remainder of the prescription, if the pain persists, up to a 30-day maximum. Urged lawmakers to include language in the final House opioids legislative package to ensure healthcare providers who are engaged in population health initiatives have access to the medical records they need, including information on substance use disorders, to effectively and safely treat their patients; Urged lawmakers to reach agreement on a final conference report to the Comprehensive Addiction and Recovery Act (CARA) that would include: Development of a federal interagency task force to review, modify, and update, as appropriate, best practices for pain management and prescribing pain medication; Grants to states to expand awareness and education of physicians, patients, health care providers regarding the risks associated with the misuse of opioids; A comprehensive Prescription Drug Monitoring Program (PDMP) to track the dispensing of controlled substances; Increased availability of opioid overdose reversal drugs; Alternatives to incarceration to individuals who misuse opioid drugs and other substances to manage their pain. Zika: ACP urged lawmakers to pass legislation that would provide the highest possible funding level for research, prevention, control, and treatment of illnesses associated with the Zika virus that is commensurate with the public health emergency that the virus represents. Prescription Drugs: ACP advocated support for lawmakers efforts in preventing some brand-name drug-companies from using statutorily required Food and Drug Administration (FDA) risk and safety programs to stifle other companies development of generic and biosimilar versions of brand-name drugs, specifically through introduction of the CREATES Act. Urged lawmakers to increase transparency in drug pricing by requiring pharmaceutical manufacturers to publically disclose production costs including research and development investments for specific high�cost drugs that the Secretary identifies through regulation; Authorize and appropriate $2.74 billion in discretionary spending for the FDA to expedite, through fast-track approval, new drugs that address unmet medical need in the treatment of a serious or life threatening condition, as well as to address the back-log of pending generic drug applications; Grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for prescription drugs covered under Part D of the Medicare program. Expressed support for S. 41, the Medicare Prescription Drug Price Negotiation Act that will empower the Secretary of Health and Human Services to negotiate with pharmaceutical manufacturers the prices (including discounts, rebates, and other price concessions) that may be charged for prescription drugs covered under Medicare Part D in prescription drug plans that participate in this program. Medical Liability Reform: Expressed support for H.R. 1215, the Protecting Access to Care Act of 2017, which would set a federal limit on the amount of non-economic damages to $250,000 and would enact a fair share rule that specifies that in any health care lawsuit, each party shall be liable for that partys share of damages only and not for the share of any other person. It would specify that any state law that imposes different standards on non-economic damages or separate limits on a partys share of damages would supersede any new caps imposed by this legislation regardless of whether the amount imposed by the states is greater or less than those imposed by H.R. 1215. Chronic Care Management: Urged lawmakers to eliminate the beneficiary co-pay for chronic care management (CCM) services, require reimbursement and coverage of additional codes for more complex CCM services, direct HHS to authorize payment for CCM codes to allow physicians to spend up to 40 minutes with a patient and an additional code that would allow for 60 minutes of treatment for a patient with multiple chronic illnesses. Telemedicine: Urged lawmakers to broadly lift geographic restrictions on telemedicine, facilitate the use of such telehealth services in stroke treatment, and incorporate the use of these services into ACOs, cosponsor bipartisan legislation, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) For Health Act (the CONNECT For Health Act), H.R. 4442/S. 2484, which would expand the use of telemedicine and remote patient monitoring (RPM) services by physicians to improve care of patients enrolled in Medicare. Mental Health: Urged lawmakers to establish grants, including Innovation and Demonstration grants, to State and local governments, educational institutions, and nonprofit organizations for integrating or coordinating physical health, mental health and substance abuse services; Provide a defined portion of grant funding to the effective integration of services to address mental illness and substance abuse within the primary care setting and to expand a workforce trained to integrate behavioral health within the primary care setting. 21st Century Cures Act: Advocated with Congress on several elements of the 21st Century Cures Act, comprehensive legislation designed to accelerate the discovery, development, and delivery of new cures and treatments. These elements included: support for moving the health information technology (health IT) ecosystem toward an interoperable health information network, combatting business practices that inhibit the flow of information by establishing authority for the HHS Office of Inspector General to investigate claims of information blocking and assign penalties for activities found to be interfering with the lawful sharing of electronic information, ensuring that health care clinicians are not penalized for the failure of developers of health IT in the case of information blocking, the establishment of hardship exemptions from Meaningful Use and the Merit-Based Incentive Payment System (MIPS) payment adjustments due to the decertification of an electronic health record (EHR) and, a commitment to develop a strategy around reducing regulatory and administrative burdens, improving and increasing access to treatment for patients suffering from mental health and substance use disorders and ensure better understanding and enforcement of mental health parity laws, accelerating the integration of behavioral health into the primary care setting. Vaccines: Expressed strong support to the President for the safety of vaccines; Claims that vaccines are unsafe when administered according to expert recommendations have been disproven by a robust body of medical literature, including a thorough review by the National Academy of Medicine (formerly known as the Institute of Medicine). Immigration (Health): Expressed concern that the executive order signed by President Trump on January 27, 2017 will result in discrimination against foreign-born persons from certain predominantly Muslim countries; that by restricting entry of physicians and medical students from seven designated Muslim majority countries, the order will undermine medical education and result in patients losing access to their doctors; that the 120 day ban on accepting refugees, and the indefinite ban on Syrian refugees, will contribute to an ongoing public health crisis for those affected, needlessly subjecting them to violence, injury, illness, deprivation and even death. Expressed support for S. 128, the Bar Removal of Individuals who Dream and Grow our Economy Act (BRIDGE Act), which would allow people who are eligible for or who have received work authorization and temporary relief from deportation through the Deferred Action for Childhood Arrivals (DACA) program to continue living in the U.S. with permission from the federal government for three years after the date of enactment of this legislation. Insurance Market Stabilization: Commented on the Centers for Medicare and Medicaid Services (CMS) Proposed Rule: Patient Protection and Affordable Care Act; Market Stabilization. Specifically, the Agency should not allow issuers to deny coverage enrollees with bad debt; instead, the issuer should be required to enroll the individual and allow the enrollee to pay the outstanding debt over a period of time; recommended that the open enrollment period for plan year 2018 begin on November 1, 2017 and end on January 31, 2018; States operating a state-based, state-based/federal platform, and partnership marketplaces should be permitted to establish longer open enrollment periods; Expressed concern about the proliferation of narrow provider networks, that tight provider networks coupled with inaccurate provider directories create a frustrating, confusing and expensive experience for patients seeking care from their preferred physicians.

Client expense: $89,122 · 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

H.R.471-Ensuring Patient Access and Effective Drug Enforcement Act of 2015 H.R.953-Comprehensive Addiction and Recovery Act of 2015 H.R.1641-Jason Simcakoski Memorial Opioid Safety Act H.R.1725-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 H.R.1821-Opioid Overdose Reduction Act of 2015 H.R.2298-Medicare Patient Safety and Drug Abuse Prevention Act H.R.2463-Dispose Responsibly of your Pills (DROP) Act of 2015 H.R.2536-Recovery Enhancement for Addiction Treatment (TREAT) Act H.R.2805-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 H.R.2850-Stop Overdose Stat Act of 2015 H.R.2872-Opioid Addiction Treatment Modernization Act H.R.3014-Medical Controlled Substances Transportation Act of 2015 H.R.3250-DXM Abuse Prevention Act of 2015 H.R.3537-Synthetic Drug Control Act of 2015 H.R.3677-Opioid Abuse Prevention and Treatment Act of 2015 H.R.3680-Co-Prescribing to Reduce Overdose Act of 2015 H.R.3691-Improving Treatment for Pregnant and Postpartum Women Act of 2015 H.R.3865-Cradle Act H.R.4063-Promoting Responsible Opioid Management and Incorporating Scientific Expertise Act H.R.4447-Opioid and Heroin Epidemic Emergency Supplemental Appropriations Act H.R.4499-Promoting Responsible Opioid Prescribing Act of 2016 H.R.4599-Reducing Unused Medications Act of 2016 H.R.4641-To provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes. H.R.4697-Prevevent Drug Addiction Act of 2016 S.36-Protecting Our Youth from Dangerous Synthetic Drugs Act of 2015 S.480-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 S.483-Ensuring Patient Access and Effective Drug Enforcement Act of 2015 S.524-Comprehensive Addiction and Recovery Act of 2015 S.636-Increasing the Safety of Prescription Drug Use Act of 2015 S.707-Opioid Overdose Reduction Act of 2015 S.954-FDA Accountability for Public Safety Act S.1134-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 S.1327-Synthetic Abuse and Labeling of Toxic Substances (SALTS) Act S.1392-Safer Prescribing of Controlled Substances Act S.1410-Treatment and Recovery Investment Act S.1431-Prescription Drug Abuse Prevention and Treatment Act of 2015 S.1455-Recovery Enhancement for Addiction Treatment Act S.1654-Overdose Prevention Act S.1913-Stopping Medication Abuse and Protecting Seniors Act of 2015 S.2256-Co-Prescribing Saves Lives Act of 2015 S.2562-Heroin and Prescription Drug Abuse Prevention and Reduction Act S.2567-Preventing Overprescribing for Pain Act of 2016 S.2578-Reducing Unused Medications Act of 2016 S.2687-Plan of Safe Care Improvement Act

Client expense: $462,139 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.6-21st Century Cures Act H.R.33-Protecting Volunteer Firefighters and Emergency Responders Act H.R.34-21st Century Cures Act H.R.290-Creating Access to Rehabilitation for Every Senior (CARES) Act of 2015 H.R.293-To amend title XI of the Social Security Act to exempt from manufacturer transparency reporting certain transfers used for educational purposes, and for other purposes. H.R.398-Trafficking Awareness Training for Health Care Act H.R.639-Improving Regulatory Transparency for New Medical Therapies Act H.R.647-Access to Life-Saving Trauma Care for All Americans Act H.R.648-Trauma Systems and Regionalization of Emergency Care Reauthorization Act H.R.836-Health Care Safety Net Enhancement Act H.R.953-Comprehensive Addiction and Recovery Act of 2015 H.R.1190-Protecting Seniors Access to Medicare Act of 2015 H.R.1571-Improving Access to Medicare Coverage Act of 2015 H.R.1641-Jason Simcakoski Memorial Opioid Safety Act H.R.1725-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 H.R.1818-Veteran Emergency Medical Technician Support Act of 2015 H.R.1821-Opioid Overdose Reduction Act of 2015 H.R.1854-Comprehensive Justice and Mental Health Act of 2015 H.R.1877-Mental Health First Aid Act of 2015 H.R.2050-Middle Class Health Benefits Tax Repeal Act of 2015 H.R.2298-Medicare Patient Safety and Drug Abuse Prevention Act H.R.2366-Field EMS Modernization and Innovation Act H.R.2463-Dispose Responsibly of your Pills (DROP) Act of 2015 H.R.2536-Recovery Enhancement for Addiction Treatment (TREAT) Act H.R.2603-Saving Lives, Saving Costs Act H.R.2646-Helping Families in Mental Health Crisis Act of 2015 H.R.2799-Furthering Access to Stroke Telemedicine (FAST) Act H.R.2805-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 H.R.2850-Stop Overdose Stat Act of 2015 H.R.2872-Opioid Addiction Treatment Modernization Act H.R.2948-Medicare Telehealth Parity Act of 2015 H.R.3014-Medical Controlled Substances Transportation Act of 2015 H.R.3081-TELEmedicine for MEDicare (TELE-MED) Act of 2015 H.R.3250-DXM Abuse Prevention Act of 2015 H.R.3299-Strengthening Public Health Emergency Response Act H.R.3537-Synthetic Drug Control Act of 2015 H.R.3677-Opioid Abuse Prevention and Treatment Act of 2015 H.R.3680-Co-Prescribing to Reduce Overdose Act of 2015 H.R.3681-Improving Access to Emergency Psychiatric Care Act H.R.3682-Reducing Employer Burdens, Unleashing Innovation, and Labor Development Act of 2015 H.R.3691-Improving Treatment for Pregnant and Postpartum Women Act of 2015 H.R.3762-Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 H.R.3770-End Surprise Billing Act of 2015 H.R.3865-Cradle Act H.R.4059-Medicare Choices Empowerment and Protection Act H.R.4063-Promoting Responsible Opioid Management and Incorporating Scientific Expertise Act H.R.4150-Department of Veterans Affairs Emergency Medical Staffing Recruitment and Retention Act H.R.4365-Protecting Patient Access to Emergency Medications Act of 2016 H.R.4435-Comprehensive Behavioral Health Reform and Recovery Act of 2016 H.R.4447-Opioid and Heroin Epidemic Emergency Supplemental Appropriations Act H.R.4499-Promoting Responsible Opioid Prescribing Act of 2016 H.R.4599-Reducing Unused Medications Act of 2016 H.R.4641-To provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes. H.R.4697-Prevevent Drug Addiction Act of 2016 H.R.4771-Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016 H.R.4732-Advancing Medical Resident Training in Community Hospitals Act of 2016 H.R.5243-Zika Response Appropriations Act H.R.5273-Helping Hospitals Improve Patient Care H.R.5284-World's Greatest Healthcare Plan Act of 2016 H.R.5547-Health Care Price Transparency Promotion Act of 2016 H.Res.877-Encouraging each State to enact legislation that increases the likelihood of survival after sudden cardiac arrest in our Nation's schools. S.141-Protecting Seniors Access to Medicare Act of 2015 S.425-Homeless Veterans' Reintegration Programs Reauthorization Act of 2015 S.453-Veteran Emergency Medical Technician Support Act of 2015 S.480-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 S.524-Comprehensive Addiction and Recovery Act of 2015 S.599-Improving Access to Emergency Psychiatric Care Act S.636-Increasing the Safety of Prescription Drug Use Act of 2015 S.707-Opioid Overdose Reduction Act of 2015 S.711-Mental Health First Act of 2015 S.763-Trauma Systems and Regionalization of Emergency Care Reauthorization Act S.884-Health Care Safety Net Enhancement Act S.843-Improving Access to Medicare Coverage Act of 2015 S.954-FDA Accountability for Public Safety Act S.993-Comprehensive Justice and Mental Health Act of 2015 S.1134-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 S.1392-Safer Prescribing of Controlled Substances Act S.1410-Treatment and Recovery Investment Act S.1431-Prescription Drug Abuse Prevention and Treatment Act of 2015 S.1446-SOAR to Health and Wellness Act of 2015 S.1450-Department of Veterans Affairs Emergency Medical Staffing Recruitment and Retention Act S.1452-Veterans Emergency Health Safety Net Expansion Act of 2015 S.1455-Recovery Enhancement for Addiction Treatment Act S.1465-Furthering Access to Stroke Telemedicine (FAST) Act S.1475-Saving Lives, Saving Costs Act S.1549-Care Planning Act of 2015 S.1648-Rural Emergency Acute Care Hospital (REACH) Act S.1654-Overdose Prevention Act S.1693-To amend title 38, United States Code, to expand eligibility for reimbursement for emergency medical treatment to certain veterans that were unable to receive care from the Department of Veterans Affairs in the 24-month period preceding the furnishing of such emergency treatment, and for other purposes. S.1778-TELEmedicine for MEDicare (TELE-MED) Act of 2015 S.1893-Mental Health Awareness and Improvement Act of 2015 S.1913-Stopping Medication Abuse and Protecting Seniors Act of 2015 S.1945-Mental Health Reform Act of 2015 S.2002-Mental Health and Safe Communities Act of 2015 S.2045-Middle Class Health Benefits Tax Repeal Act of 2015 S.2256-Co-Prescribing Saves Lives Act of 2015 S.2297-Medicare Choices Empowerment and Protection Act S.2525-Expand Excellence in Mental Health Act S.2562-Heroin and Prescription Drug Abuse Prevention and Reduction Act S.2567-Preventing Overprescribing for Pain Act of 2016 S.2578-Reducing Unused Medications Act of 2016 S.2597-Medicare Mental Health Access Act S.2671-Advancing Medical Resident Training in Community Hospitals Act of 2016 S.2680-Mental Health Reform Act of 2016 S.2687-Plan of Safe Care Improvement Act S.2932-Protecting Patient Access to Emergency Medications Act of 2016 S.2985-World's Greatest Healthcare Plan Act of 2016 S. 3407, Military Injury Surgical Systems Integrated Operationally Nationwide to Achieve ZERO Preventable Deaths (MISSION ZERO) Act P.L.114-10-Medicare Access and CHIP Reauthorization Act of 2015 P.L.114-324-Justice for All Reauthorization Act

Client expense: $462,139 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Access to Naloxone, overdose issues as follows: S.3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2017 Public Law 114-198, Comprehensive Addiction and Recovery Act of 2015 H.R.3680, Co Prescribing to Reduce Overdoses Act S.2256, Co-Prescribing Saves Lives Act of 2015 Public Law 114-255, 21st Century Cures Act

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)

Access to Naloxone, overdose issues as follows: S.3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2017 Public Law 114-198, Comprehensive Addiction and Recovery Act of 2015 H.R.3680, Co Prescribing to Reduce Overdoses Act S.2256, Co-Prescribing Saves Lives Act of 2015 Public Law 114-255, 21st Century Cures Act

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)

Reducing opioid overdose deaths; implementation of HR 3680/S 2256 provisions related to naloxone included in the conference report on S. 524, the Comprehensive Addiction and Recovery Act; pharmaceutical drug development, including epinephrine for anaphylaxis

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Reducing opioid overdose deaths; implementation of HR 3680/S 2256 provisions related to naloxone included in the conference report on S. 524, the Comprehensive Addiction and Recovery Act; pharmaceutical drug development, including epinephrine for anaphylaxis

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Preserving 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; Training more primary care physicians through the National Health Service Corps, Title VII health professions funding, and redistributing unused graduate medical education positions to primary care specialties facing shortages; Beginning in 2014, ensuring that nearly all Americans have access to coverage either through subsidized private health insurance offered by state health exchanges or through Medicaid, if they don't already have access to coverage through an employer, Medicare, or another public program. 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 in 2019; proposing specific alternatives to CMS Advancing Care Information program that is to replace the current Meaningful Use program; proposing additional improvements to simplify the reporting requirements for the Quality, Advancing Care Information and Clinical Practice Improvement 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; that CMS use its authority to adjust resource use down from 10 percent in the first performance period by setting resource use at zero and increasing the quality performance category by 10 percent to make up for the difference; that CMS ensures the utmost transparency in how the Agency attributes cost, based on the use of the patient relationship categories and codes, along with the codes for care episodes and patient conditions; that CMS allow all Accountable Care Organizations (ACOs) to be eligible to participate in Track 1+ and to not restrict participation based on ACO size or composition (ex. only physician-led ACOs or small ACOs); that CMS allow current ACOs to move into Track 1+ at the start of any performance year and not be required to wait until the beginning of their next three-year agreement period; that Track 1+ utilize the same benchmarking methodology used for the other MSSP tracks; that CMS implement a minimum threshold of 5,000 beneficiaries for Track 1+, which is consistent with the other MSSP tracks but is lower than the 10,000 (or 7,500 for rural ACOs) beneficiary threshold used in the Next Generation ACO model. Medicare Physician Fee Schedule: Commented to CMS in Sept/Oct 2016 on the proposed rule that included numerous recommendations, including but not limited to: supports the proposed code additions to the list of Medicare approved telehealth services; supports CMS proposal to review the 83 indicated codes and will be involved to the extent possible through the Relative Value Scale Update Committee (RUC) process; recommends CMS seek specific direction on how to revise and improve on the policies related to End-Stage Renal Disease home dialysis; recommends the use of CPT code 99024 (postoperative follow-up visit, normally included in the surgical package, to indicate that an evaluation and management (E/M) service was performed during a postoperative period for a reason(s) related to the original procedure) to identify the number of postoperative visits associated with a surgical procedure; urges CMS to hold clinicians providing global surgical services to the same documentation standards and guidelines as clinicians performing E/M services when providing a visit. Medical Education: Provide incentives to medical schools, community health centers, or hospitals, to increase the numbers of physicians choosing primary care; authorize HHS to selectively eliminate Graduate Medical Education (GME) caps for residency programs in primary care, advocated for S. 1627, which would increase the number of Medicare-supported training positions for medical residents by 15 percent (approximately 15,000 slots) over five years, requiring at least 50 percent of the new positions to be allocated to specialties facing a current shortage; Advocated to protect Medicare beneficiary access to health care services by preserving existing Medicare financing for Graduate Medical Education (GME). In the 114th Congress, advocated for S.1148/H.R.2124 and H.R. 1117-to strategically increase the number of GME training positions in primary care specialties (including internal medicine) and other specialties facing shortages. Urged lawmakers to combine DGME and IME into a single, more functional payment program, and broaden the GME financing structure to include all payers; Allocate GME funds transparently and specifically to activities that further the educational mission of teaching and training residents and fellows with input from practicing clinicians and in collaboration with their professional organizations. FY2017 Appropriations: Supported funding to "improve health care quality, enhance consumer choice, advance patient safety, improve efficiency, reduce medical errors, and broaden access to essential services; Advocated for funding for AHRQ and Patient Centered Outcome Research Trust Fund, the Health Resources and Services Administration (HRSA); Title VII, Section 747, Primary Care Training and Enhancement; National Health Service Corps Public Health Programs and Funding: Increase funding to accomplish the core missions and activities of the major federal public health agencies, including: biomedical and behavioral research, disease prevention and health promotion, access to safety net health care services, health professions education, mental health and substance abuse, health services research, health care for American Indians and Alaska natives, food and drug safety. Improving Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Ensure that all Americans will have access to affordable coverage. 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. Regarding the Essential Health Benefits Bulletin, issued by the Department of Health and Human Services (HHS) on December 16, 2011, the College advocated for striking a balance between comprehensiveness and affordability while giving States some freedom to determine a package that best serve the needs of residents. 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. Advocated to repeal the mandate that requires a prescription for over-the-counter medications purchased through a Health Savings Account. Advocated for legislation that would provide coverage under Medicare for voluntary consultations between doctors and patients to discuss advance care plans, as included in H.R. 1173, the Personalize Your Care Act of 2013; advocated in Aug. 2014 for the Medicare Advantage Participants Bill of Rights, H.R. 4998 and S. 2552, that would prevent Medicare Advantage plans from terminating physicians from Medicare Advantage plan networks without sufficient notice or cause. 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 premium subsidies in the event that the Supreme Court rules in favor of the petitioners in the King versus Burwell case. Congress should not make changes in the ACA that would result in more uninsured persons or weaken consumer protections. 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 establishing of a new CMS Innovation Center to pilot-test new payment models, such as the medical home; 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. National workforce policy to ensure sufficient numbers of primary care and other physicians: Increase funding for scholarships and loan repayment programs under Title VII as well as increase funding for the National Health Service Corps (NHSC); Provide new practice-entry bonus for scholarship or loan repayment award recipients who remain in underserved communities after completion of service obligation. Health Information Technology: Commented to HHS Office of the National Coordinator for Health Information Technologys (ONCs) Draft 2017 Interoperability Standards Advisory (ISA), recommending that ONC focus its efforts to identify, repair, and mitigate the negative effects of rapidly spreading bad data; rather than requiring EHRs and other clinical health IT to support multiple separate standards for extracting data for quality, public health, research, payment, and other reporting purposes, ONC should commission development of a single application programming interface (API) for all of the query and data extraction requirements. Urged lawmakers to require the Office of the National Coordinator (ONC) to develop and implement national EHR interoperability standards with direct input from practicing clinicians on the necessary data elements for care delivery, quality improvement and reporting, including the need for a narrative that provides the context of the care needed; Exempt clinicians in small/medium-sized practices from unfunded mandates that require them to purchase health IT software, services or infrastructure to support data exchanges with little or no clinical value, as determined by the Secretary with input from practicing physicians. Opioid Abuse: ACP supports efforts in trying to improve access to care and treatment for those suffering from mental health and substance abuse disorders. As contained in S. 2256, Co-Prescribing Saves Lives Act of 2015, ACP supports a comprehensive national policy on prescription drug abuse containing education, monitoring, proper disposal, and enforcement elements. As contained in S. 2256, Co-Prescribing Saves Lives Act of 2015, ACP is supportive of expanding access to naloxone within the community. ACP also supports the policy proposal known as partial-fill. This would allow a patient to elect to receive a portion of a prescription, and return for either a portion of, or the remainder of the prescription, if the pain persists, up to a 30-day maximum. Urged lawmakers to include language in the final House opioids legislative package to ensure healthcare providers who are engaged in population health initiatives have access to the medical records they need, including information on substance use disorders, to effectively and safely treat their patients; Urged lawmakers to reach agreement on a final conference report to the Comprehensive Addiction and Recovery Act (CARA) that would include: Development of a federal interagency task force to review, modify, and update, as appropriate, best practices for pain management and prescribing pain medication; Grants to states to expand awareness and education of physicians, patients, health care providers regarding the risks associated with the misuse of opioids; A comprehensive Prescription Drug Monitoring Program (PDMP) to track the dispensing of controlled substances; Increased availability of opioid overdose reversal drugs; Alternatives to incarceration to individuals who misuse opioid drugs and other substances to manage their pain. Zika: ACP urged lawmakers to pass legislation that would provide the highest possible funding level for research, prevention, control, and treatment of illnesses associated with the Zika virus that is commensurate with the public health emergency that the virus represents. Prescription Drugs: ACP advocated support for lawmakers efforts in preventing some brand-name drug-companies from using statutorily required Food and Drug Administration (FDA) risk and safety programs to stifle other companies development of generic and biosimilar versions of brand-name drugs, specifically through introduction of the CREATES Act of 2016. Urged lawmakers to increase transparency in drug pricing by requiring pharmaceutical manufacturers to publically disclose production costs including research and development investments for specific high�cost drugs that the Secretary identifies through regulation; Authorize and appropriate $2.74 billion in discretionary spending for the FDA to expedite, through fast-track approval, new drugs that address unmet medical need in the treatment of a serious or life threatening condition, as well as to address the back-log of pending generic drug applications; Grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for prescription drugs covered under Part D of the Medicare program. Firearms: ACP urged lawmakers to expand background checks on all gun purchases making it more difficult for known or suspected terrorists to purchase firearms; Urged lawmakers to reject a proposal that would allow people who have been involuntarily committed due to severe mental illness to buy a gun immediately after leaving a psychiatric hospital and enable veterans who suffer from severe mental illness, and who are at risk of suicide, to legally buy guns. Chronic Care Management: Urged lawmakers to eliminate the beneficiary co-pay for chronic care management (CCM) services, require reimbursement and coverage of additional codes for more complex CCM services, direct HHS to authorize payment for CCM codes to allow physicians to spend up to 40 minutes with a patient and an additional code that would allow for 60 minutes of treatment for a patient with multiple chronic illnesses. Telemedicine: Urged lawmakers to broadly lift geographic restrictions on telemedicine, facilitate the use of such telehealth services in stroke treatment, and incorporate the use of these services into ACOs, cosponsor bipartisan legislation, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) For Health Act (the CONNECT For Health Act), H.R. 4442/S. 2484, which would expand the use of telemedicine and remote patient monitoring (RPM) services by physicians to improve care of patients enrolled in Medicare. Mental Health: Urged lawmakers to establish grants, including Innovation and Demonstration grants, to State and local governments, educational institutions, and nonprofit organizations for integrating or coordinating physical health, mental health and substance abuse services; Provide a defined portion of grant funding to the effective integration of services to address mental illness and substance abuse within the primary care setting and to expand a workforce trained to integrate behavioral health within the primary care setting. Veterans Affairs: Commented on the VAs proposed rule regarding Advanced Practice Registered Nurses, specifically: Urged the VA to eliminate the proposal to amend the medical regulations within the VA to permit full practice authority for all VA APRNs (which include Certified Nurse Practitioners, Certified Registered Nurse Anesthetists, Clinical Nurse Specialists, and Certified Nurse-Midwives) when they are acting within the scope of their VA employment, thereby broadly preempting applicable state laws that do not grant such authority; Urged the VA to implement alternative approaches that support dynamic clinical care teams rather than by granting full independent practice authority to APRNs. 21st Century Cures Act: Advocated with Congress on several elements of the 21st Century Cures Act, comprehensive legislation designed to accelerate the discovery, development, and delivery of new cures and treatments. These elements included: support for moving the health information technology (health IT) ecosystem toward an interoperable health information network, combatting business practices that inhibit the flow of information by establishing authority for the HHS Office of Inspector General to investigate claims of information blocking and assign penalties for activities found to be interfering with the lawful sharing of electronic information, ensuring that health care clinicians are not penalized for the failure of developers of health IT in the case of information blocking, the establishment of hardship exemptions from Meaningful Use and the Merit-Based Incentive Payment System (MIPS) payment adjustments due to the decertification of an electronic health record (EHR) and, a commitment to develop a strategy around reducing regulatory and administrative burdens, improving and increasing access to treatment for patients suffering from mental health and substance use disorders and ensure better understanding and enforcement of mental health parity laws, accelerating the integration of behavioral health into the primary care setting.

Client expense: $243,989 · 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, Veterans Affairs, Dept of (VA)

Preserving 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; Training more primary care physicians through the National Health Service Corps, Title VII health professions funding, and redistributing unused graduate medical education positions to primary care specialties facing shortages; Beginning in 2014, ensuring that nearly all Americans have access to coverage either through subsidized private health insurance offered by state health exchanges or through Medicaid, if they don't already have access to coverage through an employer, Medicare, or another public program. 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 in 2019; proposing specific alternatives to CMS Advancing Care Information program that is to replace the current Meaningful Use program; proposing additional improvements to simplify the reporting requirements for the Quality, Advancing Care Information and Clinical Practice Improvement 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; that CMS use its authority to adjust resource use down from 10 percent in the first performance period by setting resource use at zero and increasing the quality performance category by 10 percent to make up for the difference; that CMS ensures the utmost transparency in how the Agency attributes cost, based on the use of the patient relationship categories and codes, along with the codes for care episodes and patient conditions; that CMS allow all Accountable Care Organizations (ACOs) to be eligible to participate in Track 1+ and to not restrict participation based on ACO size or composition (ex. only physician-led ACOs or small ACOs); that CMS allow current ACOs to move into Track 1+ at the start of any performance year and not be required to wait until the beginning of their next three-year agreement period; that Track 1+ utilize the same benchmarking methodology used for the other MSSP tracks; that CMS implement a minimum threshold of 5,000 beneficiaries for Track 1+, which is consistent with the other MSSP tracks but is lower than the 10,000 (or 7,500 for rural ACOs) beneficiary threshold used in the Next Generation ACO model. Medicare Physician Fee Schedule: Commented to CMS in Sept/Oct 2016 on the proposed rule that included numerous recommendations, including but not limited to: supports the proposed code additions to the list of Medicare approved telehealth services; supports CMS proposal to review the 83 indicated codes and will be involved to the extent possible through the Relative Value Scale Update Committee (RUC) process; recommends CMS seek specific direction on how to revise and improve on the policies related to End-Stage Renal Disease home dialysis; recommends the use of CPT code 99024 (postoperative follow-up visit, normally included in the surgical package, to indicate that an evaluation and management (E/M) service was performed during a postoperative period for a reason(s) related to the original procedure) to identify the number of postoperative visits associated with a surgical procedure; urges CMS to hold clinicians providing global surgical services to the same documentation standards and guidelines as clinicians performing E/M services when providing a visit. Medical Education: Provide incentives to medical schools, community health centers, or hospitals, to increase the numbers of physicians choosing primary care; authorize HHS to selectively eliminate Graduate Medical Education (GME) caps for residency programs in primary care, advocated for S. 1627, which would increase the number of Medicare-supported training positions for medical residents by 15 percent (approximately 15,000 slots) over five years, requiring at least 50 percent of the new positions to be allocated to specialties facing a current shortage; Advocated to protect Medicare beneficiary access to health care services by preserving existing Medicare financing for Graduate Medical Education (GME). In the 114th Congress, advocated for S.1148/H.R.2124 and H.R. 1117-to strategically increase the number of GME training positions in primary care specialties (including internal medicine) and other specialties facing shortages. Urged lawmakers to combine DGME and IME into a single, more functional payment program, and broaden the GME financing structure to include all payers; Allocate GME funds transparently and specifically to activities that further the educational mission of teaching and training residents and fellows with input from practicing clinicians and in collaboration with their professional organizations FY2017 Appropriations: Supported funding to "improve health care quality, enhance consumer choice, advance patient safety, improve efficiency, reduce medical errors, and broaden access to essential services; Advocated for funding for AHRQ and Patient Centered Outcome Research Trust Fund, the Health Resources and Services Administration (HRSA); Title VII, Section 747, Primary Care Training and Enhancement; National Health Service Corps Public Health Programs and Funding: Increase funding to accomplish the core missions and activities of the major federal public health agencies, including: biomedical and behavioral research, disease prevention and health promotion, access to safety net health care services, health professions education, mental health and substance abuse, health services research, health care for American Indians and Alaska natives, food and drug safety. Improving Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Ensure that all Americans will have access to affordable coverage. 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. Regarding the Essential Health Benefits Bulletin, issued by the Department of Health and Human Services (HHS) on December 16, 2011, the College advocated for striking a balance between comprehensiveness and affordability while giving States some freedom to determine a package that best serve the needs of residents. 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. Advocated to repeal the mandate that requires a prescription for over-the-counter medications purchased through a Health Savings Account. Advocated for legislation that would provide coverage under Medicare for voluntary consultations between doctors and patients to discuss advance care plans, as included in H.R. 1173, the Personalize Your Care Act of 2013; advocated in Aug. 2014 for the Medicare Advantage Participants Bill of Rights, H.R. 4998 and S. 2552, that would prevent Medicare Advantage plans from terminating physicians from Medicare Advantage plan networks without sufficient notice or cause. 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 premium subsidies in the event that the Supreme Court rules in favor of the petitioners in the King versus Burwell case. Congress should not make changes in the ACA that would result in more uninsured persons or weaken consumer protections. 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 establishing of a new CMS Innovation Center to pilot-test new payment models, such as the medical home; 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. National workforce policy to ensure sufficient numbers of primary care and other physicians: Increase funding for scholarships and loan repayment programs under Title VII as well as increase funding for the National Health Service Corps (NHSC); Provide new practice-entry bonus for scholarship or loan repayment award recipients who remain in underserved communities after completion of service obligation. Health Information Technology: Commented to HHS Office of the National Coordinator for Health Information Technologys (ONCs) Draft 2017 Interoperability Standards Advisory (ISA), recommending that ONC focus its efforts to identify, repair, and mitigate the negative effects of rapidly spreading bad data; rather than requiring EHRs and other clinical health IT to support multiple separate standards for extracting data for quality, public health, research, payment, and other reporting purposes, ONC should commission development of a single application programming interface (API) for all of the query and data extraction requirements. Urged lawmakers to require the Office of the National Coordinator (ONC) to develop and implement national EHR interoperability standards with direct input from practicing clinicians on the necessary data elements for care delivery, quality improvement and reporting, including the need for a narrative that provides the context of the care needed; Exempt clinicians in small/medium-sized practices from unfunded mandates that require them to purchase health IT software, services or infrastructure to support data exchanges with little or no clinical value, as determined by the Secretary with input from practicing physicians. Opioid Abuse: ACP supports efforts in trying to improve access to care and treatment for those suffering from mental health and substance abuse disorders. As contained in S. 2256, Co-Prescribing Saves Lives Act of 2015, ACP supports a comprehensive national policy on prescription drug abuse containing education, monitoring, proper disposal, and enforcement elements. As contained in S. 2256, Co-Prescribing Saves Lives Act of 2015, ACP is supportive of expanding access to naloxone within the community. ACP also supports the policy proposal known as partial-fill. This would allow a patient to elect to receive a portion of a prescription, and return for either a portion of, or the remainder of the prescription, if the pain persists, up to a 30-day maximum. Urged lawmakers to include language in the final House opioids legislative package to ensure healthcare providers who are engaged in population health initiatives have access to the medical records they need, including information on substance use disorders, to effectively and safely treat their patients; Urged lawmakers to reach agreement on a final conference report to the Comprehensive Addiction and Recovery Act (CARA) that would include: Development of a federal interagency task force to review, modify, and update, as appropriate, best practices for pain management and prescribing pain medication; Grants to states to expand awareness and education of physicians, patients, health care providers regarding the risks associated with the misuse of opioids; A comprehensive Prescription Drug Monitoring Program (PDMP) to track the dispensing of controlled substances; Increased availability of opioid overdose reversal drugs; Alternatives to incarceration to individuals who misuse opioid drugs and other substances to manage their pain. Zika: ACP urged lawmakers to pass legislation that would provide the highest possible funding level for research, prevention, control, and treatment of illnesses associated with the Zika virus that is commensurate with the public health emergency that the virus represents. Prescription Drugs: ACP advocated support for lawmakers efforts in preventing some brand-name drug-companies from using statutorily required Food and Drug Administration (FDA) risk and safety programs to stifle other companies development of generic and biosimilar versions of brand-name drugs, specifically through introduction of the CREATES Act of 2016. Urged lawmakers to increase transparency in drug pricing by requiring pharmaceutical manufacturers to publically disclose production costs including research and development investments for specific high�cost drugs that the Secretary identifies through regulation; Authorize and appropriate $2.74 billion in discretionary spending for the FDA to expedite, through fast-track approval, new drugs that address unmet medical need in the treatment of a serious or life threatening condition, as well as to address the back-log of pending generic drug applications; Grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for prescription drugs covered under Part D of the Medicare program. Firearms: ACP urged lawmakers to expand background checks on all gun purchases making it more difficult for known or suspected terrorists to purchase firearms; Urged lawmakers to reject a proposal that would allow people who have been involuntarily committed due to severe mental illness to buy a gun immediately after leaving a psychiatric hospital and enable veterans who suffer from severe mental illness, and who are at risk of suicide, to legally buy guns. Chronic Care Management: Urged lawmakers to eliminate the beneficiary co-pay for chronic care management (CCM) services, require reimbursement and coverage of additional codes for more complex CCM services, direct HHS to authorize payment for CCM codes to allow physicians to spend up to 40 minutes with a patient and an additional code that would allow for 60 minutes of treatment for a patient with multiple chronic illnesses. Telemedicine: Urged lawmakers to broadly lift geographic restrictions on telemedicine, facilitate the use of such telehealth services in stroke treatment, and incorporate the use of these services into ACOs, cosponsor bipartisan legislation, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) For Health Act (the CONNECT For Health Act), H.R. 4442/S. 2484, which would expand the use of telemedicine and remote patient monitoring (RPM) services by physicians to improve care of patients enrolled in Medicare. Mental Health: Urged lawmakers to establish grants, including Innovation and Demonstration grants, to State and local governments, educational institutions, and nonprofit organizations for integrating or coordinating physical health, mental health and substance abuse services; Provide a defined portion of grant funding to the effective integration of services to address mental illness and substance abuse within the primary care setting and to expand a workforce trained to integrate behavioral health within the primary care setting. Veterans Affairs: Commented on the VAs proposed rule regarding Advanced Practice Registered Nurses, specifically: Urged the VA to eliminate the proposal to amend the medical regulations within the VA to permit full practice authority for all VA APRNs (which include Certified Nurse Practitioners, Certified Registered Nurse Anesthetists, Clinical Nurse Specialists, and Certified Nurse-Midwives) when they are acting within the scope of their VA employment, thereby broadly preempting applicable state laws that do not grant such authority; Urged the VA to implement alternative approaches that support dynamic clinical care teams rather than by granting full independent practice authority to APRNs. 21st Century Cures Act: Advocated with Congress on several elements of the 21st Century Cures Act, comprehensive legislation designed to accelerate the discovery, development, and delivery of new cures and treatments. These elements included: support for moving the health information technology (health IT) ecosystem toward an interoperable health information network, combatting business practices that inhibit the flow of information by establishing authority for the HHS Office of Inspector General to investigate claims of information blocking and assign penalties for activities found to be interfering with the lawful sharing of electronic information, ensuring that health care clinicians are not penalized for the failure of developers of health IT in the case of information blocking, the establishment of hardship exemptions from Meaningful Use and the Merit-Based Incentive Payment System (MIPS) payment adjustments due to the decertification of an electronic health record (EHR) and, a commitment to develop a strategy around reducing regulatory and administrative burdens, improving and increasing access to treatment for patients suffering from mental health and substance use disorders and ensure better understanding and enforcement of mental health parity laws, accelerating the integration of behavioral health into the primary care setting.

Client expense: $88,904 · 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, Veterans Affairs, Dept of (VA)

PL 111-148 - The Patient Protection and Affordable Care Act, implementation, comparative effectiveness H.R. 3204 - The Drug Quality and Security Act, implementation H.R. 6 - 21st Century Cures S. 2700 - FDA and NIH Workforce Authorities Modernization Act S. 185 - Promise for Antibiotics and Therapeutics for Health Act S. 2713 - Advancing Precision Medicine Act of 2016 S. 2745 - Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2742 - Promoting Biomedical Research and Public Health for Patients Act S. 2680 - Mental Health Reform Act S. 1455 - Recovery Enhancement for Addiction Treatment Act S. 2256 - Co-Prescribing Saves Lives Act S. 480 - National All Schedules Prescription Electronic Reporting S. 2687 - Plan of Safe Care Improvement Act S. 1878 - Advancing Hope Act S. 1077 - Advancing Breakthrough Medical Devices for Patients Act S. 1101 - Medical Electronic Data Technology Enhancement for Consumers Health Act S. 2055 - Medical Countermeasures Innovation Act S. 1767 - Combination Products Innovation Act S. 1597 - Patient Focused Impact Assessment Act S. 2512 - Adding Zika Virus to FDA Priority Review Voucher Program Act S. 524 - The Comprehensive Addiction and Recovery Act of 2016 S. 2912 - Right to Try Act H.R. 34 - 21st Century Cures Act no specific bills, 340B, Innovation, A Better Way, Transparency, Precision Medicine, NIH, Importation

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

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

PL 111-148 - The Patient Protection and Affordable Care Act, PL 111-152 - The Reconciliation Act of 2010, implementation, biosimilars, 340B, disclosure, comparative effectiveness research H.R. 6 - 21st Century Cures Innovation For Healthier Americans ***, no specific bill(s), health care reform, Biosimilars, PDUFA and related FDA policies, Innovation, 340B S. 2700 - FDA and NIH Workforce Authorities Modernization Act S. 185 - Promise for Antibiotics and Therapeutics for Health Act S. 2713 - Advancing Precision Medicine Act of 2016 S. 2745 - Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2742 - Promoting Biomedical Research and Public Health for Patients Act S. 2680 - Mental Health Reform Act S. 1455 - Recovery Enhancement for Addiction Treatment Act S. 2256 - Co-Prescribing Saves Lives Act S. 480 - National All Schedules Prescription Electronic Reporting S. 2687 - Plan of Safe Care Improvement Act S. 1878 - Advancing Hope Act S. 1077 - Advancing Breakthrough Medical Devices for Patients Act S. 1101 - Medical Electronic Data Technology Enhancement for Consumers Health Act S. 2055 - Medical Countermeasures Innovation Act S. 1767 - Combination Products Innovation Act S. 1597 - Patient Focused Impact Assessment Act S. 2512 - Adding Zika Virus to FDA Priority Review Voucher Program Act S. 524 - The Comprehensive Addiction and Recovery Act of 2016 S. 2912 - Right to Try Act

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

Potential future guidance on DIR: Direct and Indirect Renumeration for Pharmacies. S.2256: Co-Prescribing Saves Lives Act of 2016. H.R.244: "MAC Transparency Act," educating on how MAC pricing helps control costs for consumers. H.R.793/S.1190: "Ensuring Seniors Access to Local Pharmacies Act of 2015," importance of pharmacy networks in reducing costs. H.R.1600: "The Patients' Access to Treatment Act," educating on the importance of step therapy to ensuring optimal therapy access and cost control. Drug pricing in general. H.R.5951 and S.3308, Improving Transparency and Accuracy in Medicare Part D Spending Act.

Client expense: $50,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act - Issues related to the biopharmaceutical industry S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 - Issues related to the biopharmaceutical industry S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 - Provisions related to priority review vouchers S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act - Issues related to the biopharmaceutical industry S. 2912: A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 - Issues related to prescription drug abuse H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Kids Innovative Drugs Act (draft) The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Drug Supply Chain Security Act policy issues Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way)

Client expense: $4,550,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Pharmaceutical drug development, Reducing opiod overdose deaths and S. 707; H.R. 3680 provisions related to Nalaxone; S. 2256 provisions related to Nalaxone

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Pharmaceutical drug development, Reducing opiod overdose deaths and S. 707; H.R. 3680 provisions related to Nalaxone; S. 2256 provisions related to Nalaxone

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 793 & S. 1190 - Ensuring Seniors Access to Local Pharmacies Act; H.R. 244 -The MAC Transparency Act; HR 4981 -The Opioid Use Disorder Treatment Expansion and Modernization Act; HR 4599 - Reducing Unused Medications Act of 2016; S. 2256 - Co-Prescribing Saves Lives; HR 3680 - Co-Prescribing to Reduce Overdoses Act of 2016; S. 524 Comprehensive Addiction and Recovery Act (CARA)

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

PL 111-148 - The Patient Protection and Affordable Care Act, implementation, comparative effectiveness H.R. 3204 - The Drug Quality and Security Act, implementation H.R. 6 - 21st Century Cures S. 2700 - FDA and NIH Workforce Authorities Modernization Act S. 185 - Promise for Antibiotics and Therapeutics for Health Act S. 2713 - Advancing Precision Medicine Act of 2016 S. 2745 - Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2742 - Promoting Biomedical Research and Public Health for Patients Act S. 2680 - Mental Health Reform Act S. 1455 - Recovery Enhancement for Addiction Treatment Act S. 2256 - Co-Prescribing Saves Lives Act S. 480 - National All Schedules Prescription Electronic Reporting S. 2687 - Plan of Safe Care Improvement Act S. 1878 - Advancing Hope Act S. 1077 - Advancing Breakthrough Medical Devices for Patients Act S. 1101 - Medical Electronic Data Technology Enhancement for Consumers Health Act S. 2055 - Medical Countermeasures Innovation Act S. 1767 - Combination Products Innovation Act S. 1597 - Patient Focused Impact Assessment Act S. 2512 - Adding Zika Virus to FDA Priority Review Voucher Program Act S. 524 - The Comprehensive Addiction and Recovery Act of 2016 S. 2912 - Right to Try Act no specific bills, 340B, Innovation, A Better Way, Transparency, Precision Medicine, NIH, Importation

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

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

PL 111-148 - The Patient Protection and Affordable Care Act, PL 111-152 - The Reconciliation Act of 2010, implementation, biosimilars, 340B, disclosure, comparative effectiveness research H.R. 6 - 21st Century Cures Innovation For Healthier Americans ***, no specific bill(s), health care reform, Biosimilars, PDUFA and related FDA policies, Innovation, 340B S. 2700 - FDA and NIH Workforce Authorities Modernization Act S. 185 - Promise for Antibiotics and Therapeutics for Health Act S. 2713 - Advancing Precision Medicine Act of 2016 S. 2745 - Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2742 - Promoting Biomedical Research and Public Health for Patients Act S. 2680 - Mental Health Reform Act S. 1455 - Recovery Enhancement for Addiction Treatment Act S. 2256 - Co-Prescribing Saves Lives Act S. 480 - National All Schedules Prescription Electronic Reporting S. 2687 - Plan of Safe Care Improvement Act S. 1878 - Advancing Hope Act S. 1077 - Advancing Breakthrough Medical Devices for Patients Act S. 1101 - Medical Electronic Data Technology Enhancement for Consumers Health Act S. 2055 - Medical Countermeasures Innovation Act S. 1767 - Combination Products Innovation Act S. 1597 - Patient Focused Impact Assessment Act S. 2512 - Adding Zika Virus to FDA Priority Review Voucher Program Act S. 524 - The Comprehensive Addiction and Recovery Act of 2016 S. 2912 - Right to Try Act

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

S.524: Comprehensive Addiction and Recovery Act, focused on Prescription Drug Management Plans (PDMPs), Medicare lock-ins, partial fills and co-prescribing. S.480/H.R.1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015, educating on the importance of PDMPs and the need for federal funding. HR.4981: The Opioid Use Disorder Treatment Expansion and Modernization Act. H.R.4599/S.2578: Reducing Unused Medications Act of 2016. H.R.3680: Co-Prescribing to Reduce Overdoses Act of 2016. S.2256: Co-Prescribing Saves Lives Act of 2016. S.1945: Senate HELP mental health reform package, Mental Health Reform Act of 2016, mental health parity treatment of step therapy and prior-authorization. S.2615: Increasing Competition in Pharmaceuticals Act, support increasing generic availability. H.R.6: The 21st Century Cures Act and Senate companions, ensuring no new barriers to generic and biosimilar market entry. Generic Drug User Fee Act Reauthorization, support increasing generic availability. H.R.1600: The Patients' Access to Treatment Act, educating on the importance of step therapy to ensuring optimal therapy access and cost control. H.R.2841: the FAST Generics Act. S.3056: the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act. S.2700: Workforce Authorities Modernization Act, Section 11, Biological Product Innovation - treatment of USP compendia in approving biologics and biosimilars. Role of PBMs in Mylan pricing before Congressional hearings/investigation of Mylan. Drug pricing in general. H.R.6043 and S.3335, "Fair Accountability and Innovative Research Drug Pricing Act of 2016".

Client expense: $50,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Potential future guidance on DIR: Direct and Indirect Renumeration for Pharmacies. S.524: "Comprehensive Addiction and Recovery Act," focused on Prescription Drug Management Plans (PDMPs). S.480/H.R.1725: "National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015," educating on the importance of PDMPs and the need for federal funding. H.R.4981: The Opioid Use Disorder Treatment Expansion and Modernization Act. H.R.4599/S.2578: Reducing Unused Medications Act of 2016. H.R.3680: Co-Prescribing to Reduce Overdoses Act of 2016. S.2256: Co-Prescribing Saves Lives Act of 2016. H.R.244: "MAC Transparency Act," educating on how MAC pricing helps control costs for consumers. H.R.793/S.1190: "Ensuring Seniors Access to Local Pharmacies Act of 2015," importance of pharmacy networks in reducing costs. H.R.1600: "The Patients' Access to Treatment Act," educating on the importance of step therapy to ensuring optimal therapy access and cost control. Drug pricing in general. H.R.5951 and S.3308, Improving Transparency and Accuracy in Medicare Part D Spending Act.

Client expense: $50,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.524: Comprehensive Addiction and Recovery Act, focused on Prescription Drug Management Plans (PDMPs), Medicare lock-in, partial fills and co-prescribing. S.480/H.R.1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015, educating on the importance of PDMPs and the need for federal funding. H.R.4981: The Opioid Use Disorder Treatment Expansion and Modernization Act. H.R.4599/S.2578: Reducing Unused Medications Act of 2016. H.R.3680: Co-Prescribing to Reduce Overdoses Act of 2016. S.2256: Co-Prescribing Saves Lives Act of 2016. H.R.4784: Lower Drug Costs Through Competition Act, support increasing generic availability. S.2680: A bill to amend the Public Health Service Act to provide comprehensive mental health reform, and for other purposes. S.2615: the Increasing Competition in Pharmaceuticals Act.

Client expense: $50,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.2872, Opioid Addiction and Modernization Act; P.L.114-198, Comprehensive Addiction and Recovery Act of 2016; S.1455, Recovery Enhancement for Addiction Treatment Act (TREAT Act); S.2256, Co-Prescribing Saves Lives Act of 2015; H.R.4981, Opioid Use Disorder Treatment Expansion and Modernization Act; confronting the opioid and mental illness epidemic.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Access to Naloxone, overdose issues as follows: S.3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2017 S.524/H.R.953, Comprehensive Addiction and Recovery Act of 2015 H.R.3680, Co Prescribing to Reduce Overdoses Act S.2256, Co-Prescribing Saves Lives Act of 2015

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)

Access to Naloxone, overdose issues as follows: S.3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2017 S.524/H.R.953, Comprehensive Addiction and Recovery Act of 2015 H.R.3680, Co Prescribing to Reduce Overdoses Act S.2256, Co-Prescribing Saves Lives Act of 2015

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)

Preserving Access to Primary Care Services: Address the shortage of primary care physicians; designate primary care as a shortage profession; 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 (111th Congress). Support Implementation and Improvement of 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; Establishing a new Patient-Centered Outcomes Research Institute to help physicians and patients make care decisions based on the best available evidence; Creating a new Center on Medicare and Medicaid Innovation to fund pilots of delivery models to improve outcomes and reduce costs, including patient-centered medical homes; Training more primary care physicians through the National Health Service Corps, Title VII health professions funding, and redistributing unused graduate medical education positions to primary care specialties facing shortages; Beginning in 2014, ensuring that nearly all Americans have access to coverage either through subsidized private health insurance offered by state health exchanges or through Medicaid, if they don't already have access to coverage through an employer, Medicare, or another public program. 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; Praised members of Congress for the bipartisan effort in finally ending the SGR and for passing H.R. 2; Advocated with CMS on numerous aspects of the MACRA proposed rule, 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 in 2019; proposing specific alternatives to CMS Advancing Care Information program that is to replace the current Meaningful Use program; proposing additional improvements to simplify the reporting requirements for the Quality, Advancing Care Information and Clinical Practice Improvement 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; that CMS use its authority to adjust resource use down from 10 percent in the first performance period by setting resource use at zero and increasing the quality performance category by 10 percent to make up for the difference; that CMS ensures the utmost transparency in how the Agency attributes cost, based on the use of the patient relationship categories and codes, along with the codes for care episodes and patient conditions. Medicare Physician Fee Schedule: Commented to CMS in Sept. 2016 on the proposed rule that included numerous recommendations, including but not limited to: supports the proposed code additions to the list of Medicare approved telehealth services; supports CMS proposal to review the 83 indicated codes and will be involved to the extent possible through the Relative Value Scale Update Committee (RUC) process; recommends CMS seek specific direction on how to revise and improve on the policies related to End-Stage Renal Disease home dialysis; recommends the use of CPT code 99024 (postoperative follow-up visit, normally included in the surgical package, to indicate that an evaluation and management (E/M) service was performed during a postoperative period for a reason(s) related to the original procedure) to identify the number of postoperative visits associated with a surgical procedure; urges CMS to hold clinicians providing global surgical services to the same documentation standards and guidelines as clinicians performing E/M services when providing a visit. Medical Education: Provide incentives to medical schools, community health centers, or hospitals, to increase the numbers of physicians choosing primary care; authorize HHS to selectively eliminate Graduate Medical Education (GME) caps for residency programs in primary care, advocated for S. 1627, which would increase the number of Medicare-supported training positions for medical residents by 15 percent (approximately 15,000 slots) over five years, requiring at least 50 percent of the new positions to be allocated to specialties facing a current shortage; Advocated to protect Medicare beneficiary access to health care services by preserving existing Medicare financing for Graduate Medical Education (GME). In the 114th Congress, advocated for S.1148/H.R.2124 and H.R. 1117-to strategically increase the number of GME training positions in primary care specialties (including internal medicine) and other specialties facing shortages. Urged lawmakers to combine DGME and IME into a single, more functional payment program, and broaden the GME financing structure to include all payers; Allocate GME funds transparently and specifically to activities that further the educational mission of teaching and training residents and fellows with input from practicing clinicians and in collaboration with their professional organizations. FY2017 Appropriations: Supported funding to "improve health care quality, enhance consumer choice, advance patient safety, improve efficiency, reduce medical errors, and broaden access to essential services; Advocated for funding for AHRQ and Patient Centered Outcome Research Trust Fund, the Health Resources and Services Administration (HRSA); Title VII, Section 747, Primary Care Training and Enhancement; National Health Service Corps Public Health Programs and Funding: Increase funding to accomplish the core missions and activities of the major federal public health agencies, including: biomedical and behavioral research, disease prevention and health promotion, access to safety net health care services, health professions education, mental health and substance abuse, health services research, health care for American Indians and Alaska natives, food and drug safety. Improving Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Ensure that all Americans will have access to affordable coverage. 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. Regarding the Essential Health Benefits Bulletin, issued by the Department of Health and Human Services (HHS) on December 16, 2011, the College advocated for striking a balance between comprehensiveness and affordability while giving States some freedom to determine a package that best serve the needs of residents. 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. Advocated to repeal the mandate that requires a prescription for over-the-counter medications purchased through a Health Savings Account. Advocated for legislation that would provide coverage under Medicare for voluntary consultations between doctors and patients to discuss advance care plans, as included in H.R. 1173, the Personalize Your Care Act of 2013; advocated in Aug. 2014 for the Medicare Advantage Participants Bill of Rights, H.R. 4998 and S. 2552, that would prevent Medicare Advantage plans from terminating physicians from Medicare Advantage plan networks without sufficient notice or cause. 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 premium subsidies in the event that the Supreme Court rules in favor of the petitioners in the King versus Burwell case. Congress should not make changes in the ACA that would result in more uninsured persons or weaken consumer protections. Pilot test new 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 establishing of a new CMS Innovation Center to pilot-test new payment models, such as the medical home; 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. National workforce policy to ensure sufficient numbers of primary care and other physicians: Urged support for a national workforce commission to recommend national goals relating to the numbers and distribution of physicians and other health care professionals, including increasing the supply of primary care physicians; Fully fund the commission at levels authorized in the Affordable Care Act; Increase the number of Medicare-funded graduate medical education positions available each year in adult primary care specialties; Provide new loan repayment and medical school scholarship programs in exchange for primary care service in critical shortage health facilities, or in critical shortage areas of the country; Increase funding for scholarships and loan repayment programs under Title VII as well as increase funding for the National Health Service Corps (NHSC); Provide new practice-entry bonus for scholarship or loan repayment award recipients who remain in underserved communities after completion of service obligation. Reform the medical liability system and the enormous costs associated with frivolous lawsuits and defensive medicine: Impose caps on non-economic damages; and test and fund new models--like health courts, which would have cases heard by an expert panel rather than by a lay jury; Advocated for the Saving Lives, Saving Costs Act (H.R. 4106 in the 113th Congress), which establishes a framework for health care liability lawsuits to undergo review by independent medical review panels if health care professionals (practicing physicians or their agents or employees) allege adherence to applicable clinical practice guidelines in the provision of health care goods or services. Workforce: Advocated for H.R. 1201 (113th Congress), The Training Tomorrow's Doctors Today Act, S. 577 (113th Congress), the Resident Physician Shortage Reduction Act of 2013, H.R. 487 (113th Congress), the Primary Care Workforce Access and Improvement Act of 2013 (113th Congress). Health Information Technology: Urged support for H.R. 3309, the Further Flexibility in Health Information Technology (HIT) Reporting and Advancing Interoperability Act (Flex-IT 2 Act); Advocated that CMS pause the implementation of Stage 3 meaningful use requirements until the new Merit-Based Incentive Payment System (MIPS) is ready to be implemented, and shorten the reporting period for the EHR Incentive Payment Programs from twelve months each year to three months. H.R. 3309 would also provide the Secretary of HHS greater flexibility to change, suspend, or revoke meaningful use criteria if the requirements are not consistent with the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) that was signed into law last year. Urged lawmakers to require the Office of the National Coordinator (ONC) to develop and implement national EHR interoperability standards with direct input from practicing clinicians on the necessary data elements for care delivery, quality improvement and reporting, including the need for a narrative that provides the context of the care needed; Exempt clinicians in small/medium-sized practices from unfunded mandates that require them to purchase health IT software, services or infrastructure to support data exchanges with little or no clinical value, as determined by the Secretary with input from practicing physicians. Opioid Abuse: ACP supports efforts in trying to improve access to care and treatment for those suffering from mental health and substance abuse disorders. As contained in S. 2256, Co-Prescribing Saves Lives Act of 2015, ACP supports a comprehensive national policy on prescription drug abuse containing education, monitoring, proper disposal, and enforcement elements. As contained in S. 2256, Co-Prescribing Saves Lives Act of 2015, ACP is supportive of expanding access to naloxone within the community. ACP also supports the policy proposal known as partial-fill. This would allow a patient to elect to receive a portion of a prescription, and return for either a portion of, or the remainder of the prescription, if the pain persists, up to a 30-day maximum. Urged lawmakers to include language in the final House opioids legislative package to ensure healthcare providers who are engaged in population health initiatives have access to the medical records they need, including information on substance use disorders, to effectively and safely treat their patients; Urged lawmakers to reach agreement on a final conference report to the Comprehensive Addiction and Recovery Act (CARA) that would include: Development of a federal interagency task force to review, modify, and update, as appropriate, best practices for pain management and prescribing pain medication; Grants to states to expand awareness and education of physicians, patients, health care providers regarding the risks associated with the misuse of opioids; A comprehensive Prescription Drug Monitoring Program (PDMP) to track the dispensing of controlled substances; Increased availability of opioid overdose reversal drugs; Alternatives to incarceration to individuals who misuse opioid drugs and other substances to manage their pain. Medicare Part B Payment Model: ACP provided comments on CMS proposed Part B payment model, including urging CMS to reassess implementing the proposal to change the current ASP+6% payment structure to the proposed ASP+2.5%+$16.80 rate because of the severe negative impact it may have on some physicians and their practices and appropriate patient access to needed medications. Zika: ACP urged lawmakers to pass legislation that would provide the highest possible funding level for research, prevention, control, and treatment of illnesses associated with the Zika virus that is commensurate with the public health emergency that the virus represents. Prescription Drugs: ACP advocated support for lawmakers efforts in preventing some brand-name drug-companies from using statutorily required Food and Drug Administration (FDA) risk and safety programs to stifle other companies development of generic and biosimilar versions of brand-name drugs, specifically through introduction of the CREATES Act of 2016. Urged lawmakers to increase transparency in drug pricing by requiring pharmaceutical manufacturers to publically disclose production costs including research and development investments for specific high�cost drugs that the Secretary identifies through regulation; Authorize and appropriate $2.74 billion in discretionary spending for the FDA to expedite, through fast-track approval, new drugs that address unmet medical need in the treatment of a serious or life threatening condition, as well as to address the back-log of pending generic drug applications; Grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for prescription drugs covered under Part D of the Medicare program. Firearms: ACP urged lawmakers to expand background checks on all gun purchases making it more difficult for known or suspected terrorists to purchase firearms; Urged lawmakers to reject a proposal that would allow people who have been involuntarily committed due to severe mental illness to buy a gun immediately after leaving a psychiatric hospital and enable veterans who suffer from severe mental illness, and who are at risk of suicide, to legally buy guns. Chronic Care Management: Urged lawmakers to eliminate the beneficiary co-pay for chronic care management (CCM) services, require reimbursement and coverage of additional codes for more complex CCM services, direct HHS to authorize payment for CCM codes to allow physicians to spend up to 40 minutes with a patient and an additional code that would allow for 60 minutes of treatment for a patient with multiple chronic illnesses. Telemedicine: Urged lawmakers to broadly lift geographic restrictions on telemedicine, facilitate the use of such telehealth services in stroke treatment, and incorporate the use of these services into ACOs, cosponsor bipartisan legislation, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) For Health Act (the CONNECT For Health Act), H.R. 4442/S. 2484, which would expand the use of telemedicine and remote patient monitoring (RPM) services by physicians to improve care of patients enrolled in Medicare. Mental Health: Urged lawmakers to establish grants, including Innovation and Demonstration grants, to State and local governments, educational institutions, and nonprofit organizations for integrating or coordinating physical health, mental health and substance abuse services; Provide a defined portion of grant funding to the effective integration of services to address mental illness and substance abuse within the primary care setting and to expand a workforce trained to integrate behavioral health within the primary care setting. Veterans Affairs: Commented on the VAs proposed rule regarding Advanced Practice Registered Nurses, specifically: Urged the VA to eliminate the proposal to amend the medical regulations within the VA to permit full practice authority for all VA APRNs (which include Certified Nurse Practitioners, Certified Registered Nurse Anesthetists, Clinical Nurse Specialists, and Certified Nurse-Midwives) when they are acting within the scope of their VA employment, thereby broadly preempting applicable state laws that do not grant such authority; Urged the VA to implement alternative approaches that support dynamic clinical care teams rather than by granting full independent practice authority to APRNs.

Client expense: $261,848 · 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, Veterans Affairs, Dept of (VA)

Preserving Access to Primary Care Services: Address the shortage of primary care physicians; designate primary care as a shortage profession; 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 (111th Congress). Support Implementation and Improvement of 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; Establishing a new Patient-Centered Outcomes Research Institute to help physicians and patients make care decisions based on the best available evidence; Creating a new Center on Medicare and Medicaid Innovation to fund pilots of delivery models to improve outcomes and reduce costs, including patient-centered medical homes; Training more primary care physicians through the National Health Service Corps, Title VII health professions funding, and redistributing unused graduate medical education positions to primary care specialties facing shortages; Beginning in 2014, ensuring that nearly all Americans have access to coverage either through subsidized private health insurance offered by state health exchanges or through Medicaid, if they don't already have access to coverage through an employer, Medicare, or another public program. 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; Praised members of Congress for the bipartisan effort in finally ending the SGR and for passing H.R. 2; Advocated with CMS on numerous aspects of the MACRA proposed rule, 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 in 2019; proposing specific alternatives to CMS Advancing Care Information program that is to replace the current Meaningful Use program; proposing additional improvements to simplify the reporting requirements for the Quality, Advancing Care Information and Clinical Practice Improvement 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; that CMS use its authority to adjust resource use down from 10 percent in the first performance period by setting resource use at zero and increasing the quality performance category by 10 percent to make up for the difference; that CMS ensures the utmost transparency in how the Agency attributes cost, based on the use of the patient relationship categories and codes, along with the codes for care episodes and patient conditions. Medicare Physician Fee Schedule: Commented to CMS in Sept. 2016 on the proposed rule that included numerous recommendations, including but not limited to: supports the proposed code additions to the list of Medicare approved telehealth services; supports CMS proposal to review the 83 indicated codes and will be involved to the extent possible through the Relative Value Scale Update Committee (RUC) process; recommends CMS seek specific direction on how to revise and improve on the policies related to End-Stage Renal Disease home dialysis; recommends the use of CPT code 99024 (postoperative follow-up visit, normally included in the surgical package, to indicate that an evaluation and management (E/M) service was performed during a postoperative period for a reason(s) related to the original procedure) to identify the number of postoperative visits associated with a surgical procedure; urges CMS to hold clinicians providing global surgical services to the same documentation standards and guidelines as clinicians performing E/M services when providing a visit. Medical Education: Provide incentives to medical schools, community health centers, or hospitals, to increase the numbers of physicians choosing primary care; authorize HHS to selectively eliminate Graduate Medical Education (GME) caps for residency programs in primary care, advocated for S. 1627, which would increase the number of Medicare-supported training positions for medical residents by 15 percent (approximately 15,000 slots) over five years, requiring at least 50 percent of the new positions to be allocated to specialties facing a current shortage; Advocated to protect Medicare beneficiary access to health care services by preserving existing Medicare financing for Graduate Medical Education (GME). In the 114th Congress, advocated for S.1148/H.R.2124 and H.R. 1117-to strategically increase the number of GME training positions in primary care specialties (including internal medicine) and other specialties facing shortages. Urged lawmakers to combine DGME and IME into a single, more functional payment program, and broaden the GME financing structure to include all payers; Allocate GME funds transparently and specifically to activities that further the educational mission of teaching and training residents and fellows with input from practicing clinicians and in collaboration with their professional organizations FY2017 Appropriations: Supported funding to "improve health care quality, enhance consumer choice, advance patient safety, improve efficiency, reduce medical errors, and broaden access to essential services; Advocated for funding for AHRQ and Patient Centered Outcome Research Trust Fund, the Health Resources and Services Administration (HRSA); Title VII, Section 747, Primary Care Training and Enhancement; National Health Service Corps Public Health Programs and Funding: Increase funding to accomplish the core missions and activities of the major federal public health agencies, including: biomedical and behavioral research, disease prevention and health promotion, access to safety net health care services, health professions education, mental health and substance abuse, health services research, health care for American Indians and Alaska natives, food and drug safety. Improving Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Ensure that all Americans will have access to affordable coverage. 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. Regarding the Essential Health Benefits Bulletin, issued by the Department of Health and Human Services (HHS) on December 16, 2011, the College advocated for striking a balance between comprehensiveness and affordability while giving States some freedom to determine a package that best serve the needs of residents. 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. Advocated to repeal the mandate that requires a prescription for over-the-counter medications purchased through a Health Savings Account. Advocated for legislation that would provide coverage under Medicare for voluntary consultations between doctors and patients to discuss advance care plans, as included in H.R. 1173, the Personalize Your Care Act of 2013; advocated in Aug. 2014 for the Medicare Advantage Participants Bill of Rights, H.R. 4998 and S. 2552, that would prevent Medicare Advantage plans from terminating physicians from Medicare Advantage plan networks without sufficient notice or cause. 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 premium subsidies in the event that the Supreme Court rules in favor of the petitioners in the King versus Burwell case. Congress should not make changes in the ACA that would result in more uninsured persons or weaken consumer protections. Pilot test new 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 establishing of a new CMS Innovation Center to pilot-test new payment models, such as the medical home; 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. National workforce policy to ensure sufficient numbers of primary care and other physicians: Urged support for a national workforce commission to recommend national goals relating to the numbers and distribution of physicians and other health care professionals, including increasing the supply of primary care physicians; Fully fund the commission at levels authorized in the Affordable Care Act; Increase the number of Medicare-funded graduate medical education positions available each year in adult primary care specialties; Provide new loan repayment and medical school scholarship programs in exchange for primary care service in critical shortage health facilities, or in critical shortage areas of the country; Increase funding for scholarships and loan repayment programs under Title VII as well as increase funding for the National Health Service Corps (NHSC); Provide new practice-entry bonus for scholarship or loan repayment award recipients who remain in underserved communities after completion of service obligation. Reform the medical liability system and the enormous costs associated with frivolous lawsuits and defensive medicine: Impose caps on non-economic damages; and test and fund new models--like health courts, which would have cases heard by an expert panel rather than by a lay jury; Advocated for the Saving Lives, Saving Costs Act (H.R. 4106 in the 113th Congress), which establishes a framework for health care liability lawsuits to undergo review by independent medical review panels if health care professionals (practicing physicians or their agents or employees) allege adherence to applicable clinical practice guidelines in the provision of health care goods or services.. Workforce: Advocated for H.R. 1201 (113th Congress), The Training Tomorrow's Doctors Today Act, S. 577 (113th Congress), the Resident Physician Shortage Reduction Act of 2013, H.R. 487 (113th Congress), the Primary Care Workforce Access and Improvement Act of 2013 (113th Congress). Health Information Technology: Urged support for H.R. 3309, the Further Flexibility in Health Information Technology (HIT) Reorting and Advancing Interoperability Act (Flex-IT 2 Act); Advocated that CMS pause the implementation of Stage 3 meaningful userequirements until the new Merit-Based Incentive Payment System (MIPS) is ready to be implemented, and shorten the reporting period for the EHR Incentive Payment Programs from twelve months each year to three months. H.R. 3309 would also provide the Secretary of HHS greater flexibility to change, suspend, or revoke meaningful use criteria if the requirements are not consistent with the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) that was signed into law last year. Urged lawmakers to require the Office of the National Coordinator (ONC) to develop and implement national EHR interoperability standards with direct input from practicing clinicians on the necessary data elements for care delivery, quality improvement and reporting, including the need for a narrative that provides the context of the care needed; Exempt clinicians in small/medium-sized practices from unfunded mandates that require them to purchase health IT software, services or infrastructure to support data exchanges with little or no clinical value, as determined by the Secretary with input from practicing physicians. Opioid Abuse: ACP supports efforts in trying to improve access to care and treatment for those suffering from mental health and substance abuse disorders. As contained in S. 2256, Co-Prescribing Saves Lives Act of 2015, ACP supports a comprehensive national policy on prescription drug abuse containing education, monitoring, proper disposal, and enforcement elements. As contained in S. 2256, Co-Prescribing Saves Lives Act of 2015, ACP is supportive of expanding access to naloxone within the community. ACP also supports the policy proposal known as partial-fill. This would allow a patient to elect to receive a portion of a prescription, and return for either a portion of, or the remainder of the prescription, if the pain persists, up to a 30-day maximum. Urged lawmakers to include language in the final House opioids legislative package to ensure healthcare providers who are engaged in population health initiatives have access to the medical records they need, including information on substance use disorders, to effectively and safely treat their patients; Urged lawmakers to reach agreement on a final conference report to the Comprehensive Addiction and Recovery Act (CARA) that would include: Development of a federal interagency task force to review, modify, and update, as appropriate, best practices for pain management and prescribing pain medication; Grants to states to expand awareness and education of physicians, patients, health care providers regarding the risks associated with the misuse of opioids; A comprehensive Prescription Drug Monitoring Program (PDMP) to track the dispensing of controlled substances; Increased availability of opioid overdose reversal drugs; Alternatives to incarceration to individuals who misuse opioid drugs and other substances to manage their pain. Medicare Part B Payment Model: ACP provided comments on CMS proposed Part B payment model, including urging CMS to reassess implementing the proposal to change the current ASP+6% payment structure to the proposed ASP+2.5%+$16.80 rate because of the severe negative impact it may have on some physicians and their practices and appropriate patient access to needed medications. Zika: ACP urged lawmakers to pass legislation that would provide the highest possible funding level for research, prevention, control, and treatment of illnesses associated with the Zika virus that is commensurate with the public health emergency that the virus represents. Prescription Drugs: ACP advocated support for lawmakers efforts in preventing some brand-name drug-companies from using statutorily required Food and Drug Administration (FDA) risk and safety programs to stifle other companies development of generic and biosimilar versions of brand-name drugs, specifically through introduction of the CREATES Act of 2016. Urged lawmakers to increase transparency in drug pricing by requiring pharmaceutical manufacturers to publically disclose production costs including research and development investments for specific high�cost drugs that the Secretary identifies through regulation; Authorize and appropriate $2.74 billion in discretionary spending for the FDA to expedite, through fast-track approval, new drugs that address unmet medical need in the treatment of a serious or life threatening condition, as well as to address the back-log of pending generic drug applications; Grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for prescription drugs covered under Part D of the Medicare program. Firearms: ACP urged lawmakers to expand background checks on all gun purchases making it more difficult for known or suspected terrorists to purchase firearms; Urged lawmakers to reject a proposal that would allow people who have been involuntarily committed due to severe mental illness to buy a gun immediately after leaving a psychiatric hospital and enable veterans who suffer from severe mental illness, and who are at risk of suicide, to legally buy guns. Chronic Care Management: Urged lawmakers to eliminate the beneficiary co-pay for chronic care management (CCM) services, require reimbursement and coverage of additional codes for more complex CCM services, direct HHS to authorize payment for CCM codes to allow physicians to spend up to 40 minutes with a patient and an additional code that would allow for 60 minutes of treatment for a patient with multiple chronic illnesses. Telemedicine: Urged lawmakers to broadly lift geographic restrictions on telemedicine, facilitate the use of such telehealth services in stroke treatment, and incorporate the use of these services into ACOs, cosponsor bipartisan legislation, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) For Health Act (the CONNECT For Health Act), H.R. 4442/S. 2484, which would expand the use of telemedicine and remote patient monitoring (RPM) services by physicians to improve care of patients enrolled in Medicare. Mental Health: Urged lawmakers to establish grants, including Innovation and Demonstration grants, to State and local governments, educational institutions, and nonprofit organizations for integrating or coordinating physical health, mental health and substance abuse services; Provide a defined portion of grant funding to the effective integration of services to address mental illness and substance abuse within the primary care setting and to expand a workforce trained to integrate behavioral health within the primary care setting. Veterans Affairs: Commented on the VAs proposed rule regarding Advanced Practice Registered Nurses, specifically: Urged the VA to eliminate the proposal to amend the medical regulations within the VA to permit full practice authority for all VA APRNs (which include Certified Nurse Practitioners, Certified Registered Nurse Anesthetists, Clinical Nurse Specialists, and Certified Nurse-Midwives) when they are acting within the scope of their VA employment, thereby broadly preempting applicable state laws that do not grant such authority; Urged the VA to implement alternative approaches that support dynamic clinical care teams rather than by granting full independent practice authority to APRNs.

Client expense: $87,998 · 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, Veterans Affairs, Dept of (VA)

H.R.471-Ensuring Patient Access and Effective Drug Enforcement Act of 2015 H.R.953-Comprehensive Addiction and Recovery Act of 2015 H.R.1641-Jason Simcakoski Memorial Opioid Safety Act H.R.1725-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 H.R.1821-Opioid Overdose Reduction Act of 2015 H.R.2298-Medicare Patient Safety and Drug Abuse Prevention Act H.R.2463-Dispose Responsibly of your Pills (DROP) Act of 2015 H.R.2536-Recovery Enhancement for Addiction Treatment (TREAT) Act H.R.2805-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 H.R.2850-Stop Overdose Stat Act of 2015 H.R.2872-Opioid Addiction Treatment Modernization Act H.R.3014-Medical Controlled Substances Transportation Act of 2015 H.R.3250-DXM Abuse Prevention Act of 2015 H.R.3537-Synthetic Drug Control Act of 2015 H.R.3677-Opioid Abuse Prevention and Treatment Act of 2015 H.R.3680-Co-Prescribing to Reduce Overdose Act of 2015 H.R.3691-Improving Treatment for Pregnant and Postpartum Women Act of 2015 H.R.3865-Cradle Act H.R.4063-Promoting Responsible Opioid Management and Incorporating Scientific Expertise Act H.R.4447-Opioid and Heroin Epidemic Emergency Supplemental Appropriations Act H.R.4499-Promoting Responsible Opioid Prescribing Act of 2016 H.R.4599-Reducing Unused Medications Act of 2016 H.R.4641-To provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes. H.R.4697-Prevevent Drug Addiction Act of 2016 S.36-Protecting Our Youth from Dangerous Synthetic Drugs Act of 2015 S.480-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 S.483-Ensuring Patient Access and Effective Drug Enforcement Act of 2015 S.524-Comprehensive Addiction and Recovery Act of 2015 S.636-Increasing the Safety of Prescription Drug Use Act of 2015 S.707-Opioid Overdose Reduction Act of 2015 S.954-FDA Accountability for Public Safety Act S.1134-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 S.1327-Synthetic Abuse and Labeling of Toxic Substances (SALTS) Act S.1392-Safer Prescribing of Controlled Substances Act S.1410-Treatment and Recovery Investment Act S.1431-Prescription Drug Abuse Prevention and Treatment Act of 2015 S.1455-Recovery Enhancement for Addiction Treatment Act S.1654-Overdose Prevention Act S.1913-Stopping Medication Abuse and Protecting Seniors Act of 2015 S.2256-Co-Prescribing Saves Lives Act of 2015 S.2562-Heroin and Prescription Drug Abuse Prevention and Reduction Act S.2567-Preventing Overprescribing for Pain Act of 2016 S.2578-Reducing Unused Medications Act of 2016 S.2687-Plan of Safe Care Improvement Act

Client expense: $512,329 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.6-21st Century Cures Act H.R.33-Protecting Volunteer Firefighters and Emergency Responders Act H.R.290-Creating Access to Rehabilitation for Every Senior (CARES) Act of 2015 H.R.293-To amend title XI of the Social Security Act to exempt from manufacturer transparency reporting certain transfers used for educational purposes, and for other purposes. H.R.398-Trafficking Awareness Training for Health Care Act H.R.639-Improving Regulatory Transparency for New Medical Therapies Act H.R.647-Access to Life-Saving Trauma Care for All Americans Act H.R.648-Trauma Systems and Regionalization of Emergency Care Reauthorization Act H.R.836-Health Care Safety Net Enhancement Act H.R.953-Comprehensive Addiction and Recovery Act of 2015 H.R.1190-Protecting Seniors Access to Medicare Act of 2015 H.R.1571-Improving Access to Medicare Coverage Act of 2015 H.R.1641-Jason Simcakoski Memorial Opioid Safety Act H.R.1725-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 H.R.1818-Veteran Emergency Medical Technician Support Act of 2015 H.R.1821-Opioid Overdose Reduction Act of 2015 H.R.1854-Comprehensive Justice and Mental Health Act of 2015 H.R.1877-Mental Health First Aid Act of 2015 H.R.2050-Middle Class Health Benefits Tax Repeal Act of 2015 H.R.2298-Medicare Patient Safety and Drug Abuse Prevention Act H.R.2366-Field EMS Modernization and Innovation Act H.R.2463-Dispose Responsibly of your Pills (DROP) Act of 2015 H.R.2536-Recovery Enhancement for Addiction Treatment (TREAT) Act H.R.2603-Saving Lives, Saving Costs Act H.R.2646-Helping Families in Mental Health Crisis Act of 2015 H.R.2799-Furthering Access to Stroke Telemedicine (FAST) Act H.R.2805-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 H.R.2850-Stop Overdose Stat Act of 2015 H.R.2872-Opioid Addiction Treatment Modernization Act H.R.2948-Medicare Telehealth Parity Act of 2015 H.R.3014-Medical Controlled Substances Transportation Act of 2015 H.R.3081-TELEmedicine for MEDicare (TELE-MED) Act of 2015 H.R.3250-DXM Abuse Prevention Act of 2015 H.R.3299-Strengthening Public Health Emergency Response Act H.R.3537-Synthetic Drug Control Act of 2015 H.R.3677-Opioid Abuse Prevention and Treatment Act of 2015 H.R.3680-Co-Prescribing to Reduce Overdose Act of 2015 H.R.3681-Improving Access to Emergency Psychiatric Care Act H.R.3682-Reducing Employer Burdens, Unleashing Innovation, and Labor Development Act of 2015 H.R.3691-Improving Treatment for Pregnant and Postpartum Women Act of 2015 H.R.3762-Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 H.R.3770-End Surprise Billing Act of 2015 H.R.3865-Cradle Act H.R.4059-Medicare Choices Empowerment and Protection Act H.R.4063-Promoting Responsible Opioid Management and Incorporating Scientific Expertise Act H.R.4150-Department of Veterans Affairs Emergency Medical Staffing Recruitment and Retention Act H.R.4365-Protecting Patient Access to Emergency Medications Act of 2016 H.R.4435-Comprehensive Behavioral Health Reform and Recovery Act of 2016 H.R.4447-Opioid and Heroin Epidemic Emergency Supplemental Appropriations Act H.R.4499-Promoting Responsible Opioid Prescribing Act of 2016 H.R.4599-Reducing Unused Medications Act of 2016 H.R.4641-To provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes. H.R.4697-Prevevent Drug Addiction Act of 2016 H.R.4771-Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016 H.R.4732-Advancing Medical Resident Training in Community Hospitals Act of 2016 H.R.5243-Zika Response Appropriations Act H.R.5273-Helping Hospitals Improve Patient Care H.R.5284-World's Greatest Healthcare Plan Act of 2016 H.R.5547-Health Care Price Transparency Promotion Act of 2016 S.141-Protecting Seniors Access to Medicare Act of 2015 S.425-Homeless Veterans' Reintegration Programs Reauthorization Act of 2015 S.453-Veteran Emergency Medical Technician Support Act of 2015 S.480-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 S.524-Comprehensive Addiction and Recovery Act of 2015 S.599-Improving Access to Emergency Psychiatric Care Act S.636-Increasing the Safety of Prescription Drug Use Act of 2015 S.707-Opioid Overdose Reduction Act of 2015 S.711-Mental Health First Act of 2015 S.763-Trauma Systems and Regionalization of Emergency Care Reauthorization Act S.884-Health Care Safety Net Enhancement Act S.843-Improving Access to Medicare Coverage Act of 2015 S.954-FDA Accountability for Public Safety Act S.993-Comprehensive Justice and Mental Health Act of 2015 S.1134-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 S.1392-Safer Prescribing of Controlled Substances Act S.1410-Treatment and Recovery Investment Act S.1431-Prescription Drug Abuse Prevention and Treatment Act of 2015 S.1446-SOAR to Health and Wellness Act of 2015 S.1450-Department of Veterans Affairs Emergency Medical Staffing Recruitment and Retention Act S.1452-Veterans Emergency Health Safety Net Expansion Act of 2015 S.1455-Recovery Enhancement for Addiction Treatment Act S.1465-Furthering Access to Stroke Telemedicine (FAST) Act S.1475-Saving Lives, Saving Costs Act S.1549-Care Planning Act of 2015 S.1648-Rural Emergency Acute Care Hospital (REACH) Act S.1654-Overdose Prevention Act S.1693-To amend title 38, United States Code, to expand eligibility for reimbursement for emergency medical treatment to certain veterans that were unable to receive care from the Department of Veterans Affairs in the 24-month period preceding the furnishing of such emergency treatment, and for other purposes. S.1778-TELEmedicine for MEDicare (TELE-MED) Act of 2015 S.1893-Mental Health Awareness and Improvement Act of 2015 S.1913-Stopping Medication Abuse and Protecting Seniors Act of 2015 S.1945-Mental Health Reform Act of 2015 S.2002-Mental Health and Safe Communities Act of 2015 S.2045-Middle Class Health Benefits Tax Repeal Act of 2015 S.2256-Co-Prescribing Saves Lives Act of 2015 S.2297-Medicare Choices Empowerment and Protection Act S.2525-Expand Excellence in Mental Health Act S.2562-Heroin and Prescription Drug Abuse Prevention and Reduction Act S.2567-Preventing Overprescribing for Pain Act of 2016 S.2578-Reducing Unused Medications Act of 2016 S.2597-Medicare Mental Health Access Act S.2671-Advancing Medical Resident Training in Community Hospitals Act of 2016 S.2680-Mental Health Reform Act of 2016 S.2687-Plan of Safe Care Improvement Act S.2932-Protecting Patient Access to Emergency Medications Act of 2016 S.2985-World's Greatest Healthcare Plan Act of 2016 P.L.114-10-Medicare Access and CHIP Reauthorization Act of 2015

Client expense: $512,329 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Comprehensive Addiction and Recovery Act (S 524) Conference Report Zika Virus Response Funding (HR 2577) Mental Health Programs and Policies (HR 2646) Health Savings Accounts (HR 1270) National All Schedules Prescription Electronic Reporting Act (S. 480/HR 1725) Mental Health Reform Act of 2016 (S 2680) Recovery Enhancement for Addiction Treatment Act (S. 1455) The Co-Prescribing Saves Lives Act of 2016 (S. 2256) The Plan of Safe Care Improvement Act (S. 2687) The Partial Fill Amendment within the Managers Amendments to S 2680 Comprehensive Addiction and Recovery Act (S. 524) Comprehensive Opioid Abuse Reduction Act (HR 5046) Interagency Opioid Task Force (HR 4641) The Opioid Use Disorder Treatment Expansion and Modernization Act (HR 4981) Promoting Responsible Opioid Management and Incorporating Scientific Expertise Act - Veterans Administration (HR 4063) Good Samaritan Assessment Act (HR 4058) Opioid Program Evaluation (OPEN) Act (HR 5022) Infant Plan of Safe Care Improvement Act (HR 4843) Nurturing and Supporting Healthy Babies Act (HR 4978) Improving Treatment for Pregnant and Postpartum Women Act (HR 3691) Ensuring Removal of Terminated Providers from Medicaid & CHIP (H.R. 3716) Medication Assisted Treatment for Opioid Use Disorders (SAMHSA, RIN 0930-AA22)

Client expense: $45,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Education, Dept of, HOUSE OF REPRESENTATIVES, SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), White House Office

S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 2055 - the Medical Countermeasure Innovation Act of 2015 S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act S. 2912: A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 HR. 3299 - the Strengthening Public Health Emergency Response Act of 2015 H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Other: - Kids Innovative Drugs Act (draft) - The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments - Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development - ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances - Drug Supply Chain Security Act policy issues - Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues - Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures - Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy - Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges - 340B Drug Discount Program policy issues - General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals - Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization - Biologics Price Competition and Innovation Act (BPCIA) implementation issues - Biopharmaceutical and medical innovation policy issues - Drug development ecosystem policy issues - Drug cost and pricing policy issues - Expedited drug approval policy issues - Compassionate use policy issues - Biosimilar approval and reimbursement policy issues - Transparency policy issues - NIH Funding policy issues - Precision Medicine Initiative - Policy issues related to prescription drug abuse and secure disposal - Drug compounding policy issues - Prescription drug importation policy issues - Cancer Moonshot - Prescription drug take back policy issues - Clinical trial policy issues - Pediatric cancer policy issues - Cancer drug vial sizes policy issues - House Republican Health Proposal (A Better Way)

Client expense: $1,070,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

PL 111-148 - The Patient Protection and Affordable Care Act, implementation, comparative effectiveness H.R. 3204 - The Drug Quality and Security Act, implementation H.R. 6 - 21st Century Cures S. 2700 - FDA and NIH Workforce Authorities Modernization Act S. 185 - Promise for Antibiotics and Therapeutics for Health Act S. 2713 - Advancing Precision Medicine Act of 2016 S. 2745 - Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2742 - Promoting Biomedical Research and Public Health for Patients Act S. 2680 - Mental Health Reform Act S. 1455 - Recovery Enhancement for Addiction Treatment Act S. 2256 - Co-Prescribing Saves Lives Act S. 480 - National All Schedules Prescription Electronic Reporting S. 2687 - Plan of Safe Care Improvement Act S. 1878 - Advancing Hope Act S. 1077 - Advancing Breakthrough Medical Devices for Patients Act S. 1101 - Medical Electronic Data Technology Enhancement for Consumers Health Act S. 2055 - Medical Countermeasures Innovation Act S. 1767 - Combination Products Innovation Act S. 1597 - Patient Focused Impact Assessment Act S. 2512 - Adding Zika Virus to FDA Priority Review Voucher Program Act S. 524 - The Comprehensive Addiction and Recovery Act of 2016 S. 2912 - Right to Try Act no specific bills, 340 B, Innovation

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

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

H.R.471-Ensuring Patient Access and Effective Drug Enforcement Act of 2015 H.R.953-Comprehensive Addiction and Recovery Act of 2015 H.R.1641-Jason Simcakoski Memorial Opioid Safety Act H.R.1725-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 H.R.1821-Opioid Overdose Reduction Act of 2015 H.R.2298-Medicare Patient Safety and Drug Abuse Prevention Act H.R.2463-Dispose Responsibly of your Pills (DROP) Act of 2015 H.R.2536-Recovery Enhancement for Addiction Treatment (TREAT) Act H.R.2805-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 H.R.2850-Stop Overdose Stat Act of 2015 H.R.2872-Opioid Addiction Treatment Modernization Act H.R.3014-Medical Controlled Substances Transportation Act of 2015 H.R.3250-DXM Abuse Prevention Act of 2015 H.R.3537-Synthetic Drug Control Act of 2015 H.R.3677-Opioid Abuse Prevention and Treatment Act of 2015 H.R.3680-Co-Prescribing to Reduce Overdose Act of 2015 H.R.3691-Improving Treatment for Pregnant and Postpartum Women Act of 2015 H.R.3865-Cradle Act H.R.4063-Promoting Responsible Opioid Management and Incorporating Scientific Expertise Act H.R.4447-Opioid and Heroin Epidemic Emergency Supplemental Appropriations Act H.R.4499-Promoting Responsible Opioid Prescribing Act of 2016 H.R.4599-Reducing Unused Medications Act of 2016 H.R.4641-To provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes. H.R.4697-Prevevent Drug Addiction Act of 2016 S.36-Protecting Our Youth from Dangerous Synthetic Drugs Act of 2015 S.480-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 S.483-Ensuring Patient Access and Effective Drug Enforcement Act of 2015 S.524-Comprehensive Addiction and Recovery Act of 2015 S.636-Increasing the Safety of Prescription Drug Use Act of 2015 S.707-Opioid Overdose Reduction Act of 2015 S.954-FDA Accountability for Public Safety Act S.1134-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 S.1327-Synthetic Abuse and Labeling of Toxic Substances (SALTS) Act S.1392-Safer Prescribing of Controlled Substances Act S.1410-Treatment and Recovery Investment Act S.1431-Prescription Drug Abuse Prevention and Treatment Act of 2015 S.1455-Recovery Enhancement for Addiction Treatment Act S.1654-Overdose Prevention Act S.1913-Stopping Medication Abuse and Protecting Seniors Act of 2015 S.2256-Co-Prescribing Saves Lives Act of 2015 S.2562-Heroin and Prescription Drug Abuse Prevention and Reduction Act S.2567-Preventing Overprescribing for Pain Act of 2016 S.2578-Reducing Unused Medications Act of 2016 S.2687-Plan of Safe Care Improvement Act

Client expense: $217,135 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.6-21st Century Cures Act H.R.33-Protecting Volunteer Firefighters and Emergency Responders Act H.R.290-Creating Access to Rehabilitation for Every Senior (CARES) Act of 2015 H.R.293-To amend title XI of the Social Security Act to exempt from manufacturer transparency reporting certain transfers used for educational purposes, and for other purposes. H.R.398-Trafficking Awareness Training for Health Care Act H.R.639-Improving Regulatory Transparency for New Medical Therapies Act H.R.647-Access to Life-Saving Trauma Care for All Americans Act H.R.648-Trauma Systems and Regionalization of Emergency Care Reauthorization Act H.R.836-Health Care Safety Net Enhancement Act H.R.953-Comprehensive Addiction and Recovery Act of 2015 H.R.1190-Protecting Seniors Access to Medicare Act of 2015 H.R.1571-Improving Access to Medicare Coverage Act of 2015 H.R.1641-Jason Simcakoski Memorial Opioid Safety Act H.R.1725-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 H.R.1818-Veteran Emergency Medical Technician Support Act of 2015 H.R.1821-Opioid Overdose Reduction Act of 2015 H.R.1854-Comprehensive Justice and Mental Health Act of 2015 H.R.1877-Mental Health First Aid Act of 2015 H.R.2050-Middle Class Health Benefits Tax Repeal Act of 2015 H.R.2298-Medicare Patient Safety and Drug Abuse Prevention Act H.R.2366-Field EMS Modernization and Innovation Act H.R.2463-Dispose Responsibly of your Pills (DROP) Act of 2015 H.R.2536-Recovery Enhancement for Addiction Treatment (TREAT) Act H.R.2603-Saving Lives, Saving Costs Act H.R.2646-Helping Families in Mental Health Crisis Act of 2015 H.R.2799-Furthering Access to Stroke Telemedicine (FAST) Act H.R.2805-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 H.R.2850-Stop Overdose Stat Act of 2015 H.R.2872-Opioid Addiction Treatment Modernization Act H.R.2948-Medicare Telehealth Parity Act of 2015 H.R.3014-Medical Controlled Substances Transportation Act of 2015 H.R.3081-TELEmedicine for MEDicare (TELE-MED) Act of 2015 H.R.3250-DXM Abuse Prevention Act of 2015 H.R.3299-Strengthening Public Health Emergency Response Act H.R.3537-Synthetic Drug Control Act of 2015 H.R.3677-Opioid Abuse Prevention and Treatment Act of 2015 H.R.3680-Co-Prescribing to Reduce Overdose Act of 2015 H.R.3681-Improving Access to Emergency Psychiatric Care Act H.R.3682-Reducing Employer Burdens, Unleashing Innovation, and Labor Development Act of 2015 H.R.3691-Improving Treatment for Pregnant and Postpartum Women Act of 2015 H.R.3762-Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 H.R.3770-End Surprise Billing Act of 2015 H.R.3865-Cradle Act H.R.4059-Medicare Choices Empowerment and Protection Act H.R.4063-Promoting Responsible Opioid Management and Incorporating Scientific Expertise Act H.R.4150-Department of Veterans Affairs Emergency Medical Staffing Recruitment and Retention Act H.R.4365-Protecting Patient Access to Emergency Medications Act of 2016 H.R.4435-Comprehensive Behavioral Health Reform and Recovery Act of 2016 H.R.4447-Opioid and Heroin Epidemic Emergency Supplemental Appropriations Act H.R.4499-Promoting Responsible Opioid Prescribing Act of 2016 H.R.4599-Reducing Unused Medications Act of 2016 H.R.4641-To provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes. H.R.4697-Prevevent Drug Addiction Act of 2016 H.R.4771-Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016 H.R.4732-Advancing Medical Resident Training in Community Hospitals Act of 2016 H.R.5243-Zika Response Appropriations Act H.R.5273-Helping Hospitals Improve Patient Care H.R.5284-World's Greatest Healthcare Plan Act of 2016 H.R.5547-Health Care Price Transparency Promotion Act of 2016 S.141-Protecting Seniors Access to Medicare Act of 2015 S.425-Homeless Veterans' Reintegration Programs Reauthorization Act of 2015 S.453-Veteran Emergency Medical Technician Support Act of 2015 S.480-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 S.524-Comprehensive Addiction and Recovery Act of 2015 S.599-Improving Access to Emergency Psychiatric Care Act S.636-Increasing the Safety of Prescription Drug Use Act of 2015 S.707-Opioid Overdose Reduction Act of 2015 S.711-Mental Health First Act of 2015 S.763-Trauma Systems and Regionalization of Emergency Care Reauthorization Act S.884-Health Care Safety Net Enhancement Act S.843-Improving Access to Medicare Coverage Act of 2015 S.954-FDA Accountability for Public Safety Act S.993-Comprehensive Justice and Mental Health Act of 2015 S.1134-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 S.1392-Safer Prescribing of Controlled Substances Act S.1410-Treatment and Recovery Investment Act S.1431-Prescription Drug Abuse Prevention and Treatment Act of 2015 S.1446-SOAR to Health and Wellness Act of 2015 S.1450-Department of Veterans Affairs Emergency Medical Staffing Recruitment and Retention Act S.1452-Veterans Emergency Health Safety Net Expansion Act of 2015 S.1455-Recovery Enhancement for Addiction Treatment Act S.1465-Furthering Access to Stroke Telemedicine (FAST) Act S.1475-Saving Lives, Saving Costs Act S.1549-Care Planning Act of 2015 S.1648-Rural Emergency Acute Care Hospital (REACH) Act S.1654-Overdose Prevention Act S.1693-To amend title 38, United States Code, to expand eligibility for reimbursement for emergency medical treatment to certain veterans that were unable to receive care from the Department of Veterans Affairs in the 24-month period preceding the furnishing of such emergency treatment, and for other purposes. S.1778-TELEmedicine for MEDicare (TELE-MED) Act of 2015 S.1893-Mental Health Awareness and Improvement Act of 2015 S.1913-Stopping Medication Abuse and Protecting Seniors Act of 2015 S.1945-Mental Health Reform Act of 2015 S.2002-Mental Health and Safe Communities Act of 2015 S.2045-Middle Class Health Benefits Tax Repeal Act of 2015 S.2256-Co-Prescribing Saves Lives Act of 2015 S.2297-Medicare Choices Empowerment and Protection Act S.2525-Expand Excellence in Mental Health Act S.2562-Heroin and Prescription Drug Abuse Prevention and Reduction Act S.2567-Preventing Overprescribing for Pain Act of 2016 S.2578-Reducing Unused Medications Act of 2016 S.2597-Medicare Mental Health Access Act S.2671-Advancing Medical Resident Training in Community Hospitals Act of 2016 S.2680-Mental Health Reform Act of 2016 S.2687-Plan of Safe Care Improvement Act S.2932-Protecting Patient Access to Emergency Medications Act of 2016 S.2985-World's Greatest Healthcare Plan Act of 2016

Client expense: $217,135 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

PL 111-148 - The Patient Protection and Affordable Care Act, PL 111-152 - The Reconciliation Act of 2010, implementation, biosimilars, 340B, disclosure, comparative effectiveness research H.R. 6 - 21st Century Cures Innovation For Healthier Americans ***, no specific bill(s), health care reform, Biosimilars, PDUFA and related FDA policies, Innovation, 340B S. 2700 - FDA and NIH Workforce Authorities Modernization Act S. 185 - Promise for Antibiotics and Therapeutics for Health Act S. 2713 - Advancing Precision Medicine Act of 2016 S. 2745 - Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2742 - Promoting Biomedical Research and Public Health for Patients Act S. 2680 - Mental Health Reform Act S. 1455 - Recovery Enhancement for Addiction Treatment Act S. 2256 - Co-Prescribing Saves Lives Act S. 480 - National All Schedules Prescription Electronic Reporting S. 2687 - Plan of Safe Care Improvement Act S. 1878 - Advancing Hope Act S. 1077 - Advancing Breakthrough Medical Devices for Patients Act S. 1101 - Medical Electronic Data Technology Enhancement for Consumers Health Act S. 2055 - Medical Countermeasures Innovation Act S. 1767 - Combination Products Innovation Act S. 1597 - Patient Focused Impact Assessment Act S. 2512 - Adding Zika Virus to FDA Priority Review Voucher Program Act S. 524 - The Comprehensive Addiction and Recovery Act of 2016 S. 2912 - Right to Try Act

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act - Issues related to the biopharmaceutical industry S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 - Issues related to the biopharmaceutical industry S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 - Provisions related to priority review vouchers S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act - Issues related to the biopharmaceutical industry S. 2912: A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 - Issues related to prescription drug abuse H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Kids Innovative Drugs Act (draft) The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Drug Supply Chain Security Act policy issues Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way)

Client expense: $5,820,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

H.R.2872, Opioid Addiction and Modernization Act; S.524, Comprehensive Addiction and Recovery Act of 2016; S.1455, Recovery Enhancement for Addiction Treatment Act (TREAT Act); S.2256, Co-Prescribing Saves Lives Act of 2015; H.R.4981, Opioid Use Disorder Treatment Expansion and Modernization Act; confronting the opioid and mental illness epidemic.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 793 & S. 1190 - Ensuring Seniors Access to Local Pharmacies Act; H.R. 244 -The MAC Transparency Act; HR 4981 -The Opioid Use Disorder Treatment Expansion and Modernization Act; HR 4599 - Reducing Unused Medications Act of 2016; S. 2256 - Co-Prescribing Saves Lives; HR 3680 - Co-Prescribing to Reduce Overdoses Act of 2016; S. 524 Comprehensive Addiction and Recovery Act (CARA)

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

S.524: Comprehensive Addiction and Recovery Act, focused on Prescription Drug Management Plans (PDMPs), Medicare lock-ins, partial fills and co-prescribing. S.480/H.R.1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015, educating on the importance of PDMPs and the need for federal funding. HR.4981: The Opioid Use Disorder Treatment Expansion and Modernization Act. H.R.4599/S.2578: Reducing Unused Medications Act of 2016. H.R.3680: Co-Prescribing to Reduce Overdoses Act of 2016. S.2256: Co-Prescribing Saves Lives Act of 2016. S.1945: Senate HELP mental health reform package, Mental Health Reform Act of 2016, mental health parity treatment of step therapy and prior-authorization. S.2615: Increasing Competition in Pharmaceuticals Act, support increasing generic availability. H.R.6: The 21st Century Cures Act and Senate companions, ensuring no new barriers to generic and biosimilar market entry. Generic Drug User Fee Act Reauthorization, support increasing generic availability. H.R.1600: The Patients' Access to Treatment Act, educating on the importance of step therapy to ensuring optimal therapy access and cost control. H.R.2841: the FAST Generics Act. S.3056: the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act. S.2700: Workforce Authorities Modernization Act, Section 11, Biological Product Innovation - treatment of USP compendia in approving biologics and biosimilars.

Client expense: $50,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.524: Comprehensive Addiction and Recovery Act, focused on Prescription Drug Management Plans (PDMPs), Medicare lock-in, partial fills and co-prescribing. S.480/H.R.1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015, educating on the importance of PDMPs and the need for federal funding. H.R.4981: The Opioid Use Disorder Treatment Expansion and Modernization Act. H.R.4599/S.2578: Reducing Unused Medications Act of 2016. H.R.3680: Co-Prescribing to Reduce Overdoses Act of 2016. S.2256: Co-Prescribing Saves Lives Act of 2016. H.R.4784: Lower Drug Costs Through Competition Act, support increasing generic availability. S.2680: A bill to amend the Public Health Service Act to provide comprehensive mental health reform, and for other purposes. S.2615: the Increasing Competition in Pharmaceuticals Act.

Client expense: $50,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Potential future guidance on DIR: Direct and Indirect Renumeration for Pharmacies. S.524: "Comprehensive Addiction and Recovery Act," focused on Prescription Drug Management Plans (PDMPs). S.480/H.R.1725: "National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015," educating on the importance of PDMPs and the need for federal funding. H.R.4981: The Opioid Use Disorder Treatment Expansion and Modernization Act. H.R.4599/S.2578: Reducing Unused Medications Act of 2016. H.R.3680: Co-Prescribing to Reduce Overdoses Act of 2016. S.2256: Co-Prescribing Saves Lives Act of 2016. H.R.244: "MAC Transparency Act," educating on how MAC pricing helps control costs for consumers. H.R.793/S.1190: "Ensuring Seniors Access to Local Pharmacies Act of 2015," importance of pharmacy networks in reducing costs. H.R.1600: "The Patients' Access to Treatment Act," educating on the importance of step therapy to ensuring optimal therapy access and cost control.

Client expense: $50,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Access to Naloxone, overdose issues as follows: S.3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2017 S.524/H.R.953, Comprehensive Addiction and Recovery Act of 2015 H.R.3680, Co Prescribing to Reduce Overdoses Act S.2256, Co-Prescribing Saves Lives Act of 2015

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)