PROP Act of 2016

Opioid Abuse; Opioid Education; Prescription Drugs, HR 953 Introduced February 12, 2015 by James Sensenbrenner, Jr. (R-WI) Comprehensive Addiction and Recovery Act of 2015 Overdoses from heroin, prescription drugs, and opioid pain relievers last year surpassed car accidents as the leading cause of injury-related death in America, according to the Centers for Disease Control. Deaths have reached their highest levels of the 21st Century in 2014, the most recent year for which data is available, according to the National Institute on Drug Abuse. Heroin overdoses have more than tripled in the last five years, an issue receiving outsize attention nationally but especially during the presidential campaign season as New Hampshire has been one of the hardest-hit states. HR 2805 Heroin and Prescription Opioid Abuse Prevention, Education and Enforcement Act of 2015 Introduced June 17, 2015 by Susan Brooks (R-IN) this bill requires the Department of Health and Human Services (HHS)in cooperation with the Department of Veterans Affairs, the Department of Defense, and the Drug Enforcement Administration (DEA), to convene a Pain Management Best Practices Inter-Agency Task Force to develop and study best practices for pain management and prescription of pain medication. HR 4499 Introduced February 9, 2016 by Alex Mooney (R-VA) Promoting Responsible Opioid Prescribing Act of 2016. To amend title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program and for other purposes.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issue: Educate congressional staff on academic medicines missions, including education, research, patient care, GME, workforce, and physician shortages in rural and urban communities. Issue: Support enactment of simultaneous repeal and replace of Affordable Care Act. Support continuation high-quality affordable health insurance through preservation of ACA health care coverage including private market insurance and Medicaid expansion. Support programs and funds for safety-net providers until replace is ready Issue: Support inclusion of socioeconomic status in Hospital Compare star ratings; delay public release of ratings until data is released and reviewed by hospital community. H.R. 1006/S. 2107, Building a Health Care Workforce for the Future Act Issue: Support bill to increase scholarship opportunities for medical students and encourage primary care workforce development Issue: Reauthorization of Title VII health professions programs Issue: Diversity of the health care workforce Issue: Training in substance abuse, pain management, womens health, and mental health in medical education Issue: Strategies to prevent, identify, and treat opioid dependence Issue: Concurrent and overlapping surgery practices S. 1455, TREAT Act Issue: Support legislation to expand cap on buprenorphine Issue: Provide comments on draft legislation to increase the safety of prescription drug use H.R. 4499, Promoting Responsible Opioid Prescribing Act of 2016 Issue: Support delinking the Hospital Consumer Assessment of Healthcare Providers and Systems surveys pain management questions from the Centers for Medicare and Medicaid Services calculations of hospital incentive payments under the Value-Based Purchasing Program. Issue: Implementation of 340B Drug Pricing Program and eligibility of offsite facilities under OPPS Issue: Educate Congress on the impact of the self-referral (Stark law) on health care payment and delivery system reform, and how to promote development of alternative payment models S. 2837/H.R. 2578, FY 2017 Commerce-Justice-Science Appropriations Issue: Support amendments to expand background checks on gun purchases and make it more difficult for known/suspected terrorists to purchase firearms. H.R. 3299, Strengthening Public Health Emergency Response Act of 2015 Issue: Support provisions to strengthen the Hospitals Preparedness Program Issue: Educate Congress on the role of Academic Medical Centers in emergency preparedness Submitted comments to: -- HRSA on the 340B Drug Pricing Program; Administrative Dispute Resolution; Notice of Proposed Rulemaking

Client expense: $687,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), White House Office

H.R. 4499, Promoting Responsible Opioid Prescribing (PROP) Act of 2016, provisions relating to payment and delivery reform S. 2758, Promoting Responsible Opioid Prescribing (PROP) Act of 2016, provisions relating to payment and delivery reform S. 3130, Independence at Home Act of 2016, all provisions H.R. 3220, Medicare Common Access Card Act of 2015, all provisions S. 3504, Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2016, all provisions H.R.6333, To amend title XVIII of the Social Security Act with respect to the accreditation of osteopathic residency training programs for purposes of graduate medical education payments under the Medicare program, all provisions H.R. 976, Patient Access to Higher Quality Health Care Act of 2015, all provisions H.R. 2, Medicare Access and CHIP Reauthorization Act of 2015, provisions relating to payment and delivery reform H.R. 1470, SGR Repeal and Medicare Provider Payment Modernization Act of 2015, provisions relating to payment and delivery reform S. 810, SGR Repeal and Medicare Provider Payment Modernization Act of 2015, provisions relating to payment and delivery reform H.R. 1190, Protecting Seniors' Access to Medicare Act of 2015, all provisions S.141, Protecting Seniors' Access to Medicare Act of 2015, all provisions H.R. 4442, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act, provisions relating to telehealth S. 2484, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act, provisions relating to telehealth S. 1131, Medicare Diabetes Prevention Act of 2015, all provisions H.R. 2646, Helping Families in Mental Health Crisis Act of 2016, all provisions S. 1945, Mental Health Reform Act of 2015, all provisions S. 1913, Stopping Medication Abuse and Protecting Seniors Act of 2015, all provisions Medicare program: MACRA Implementation Medicare program: PAMA implementation Medicare program: ACO Improvement Act Medicare program: The Center for Medicare and Medicaid Innovation (CMMI) Medicare program: Repeal of the Independent Payment Advisory Board (IPAB) Medicare program: Medicare Part B Drug Demonstration Medicare program: Regulatory Relief Medicare program: CY 2017 Medicare Physician Fee Schedule Medicare program: In-Office Ancillary Services Exception (IOASE) Medicare program: Merit-Based Incentive Payment System (MIPS) Medicare program: Value-Based Payment Modifier (VPM) Medicare program: Physician Compare Medicare program: Alternate Payment Models Medicare program: Physician Quality Reporting System (PQRS) Medicare program: Graduate Medical Education (GME) Medicare program: Electronic Health Records/Meaningful Use (EHR/MU) Medicare program: Quality Reporting Medicare program: ICD-10 Medicare program: Prescription Drug Diversion Medicare program: Physician data Medicare program: Telemedicine Medicare program: Patient Relationship Codes Medicare program: Social Security Number Removal Initiative Medicaid program: Amendment to New York's section 1115 demonstration waiver

Client expense: $3,990,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office

Medical liability reform (H.R. 836/S. 884, H.R. 4771) Mental health & opioid abuse policy (H.R. 2646, H.R. 4435, S. 1893, S. 1913, S. 524, S. 2680, S. 480, S. 2687, H.R. 4843, H.R. 4499/S. 2758, H.R. 3680, H.R. 3691, H.R. 4599, H.R. 4651, H.R. 4976, H.R. 4978, H.R. 4982, H.R. 4969, H.R. 34 - 21st Century Cures Act) 340B discount drug program Chronic care policy Nurse education policy (H.R. 977/H.R. 1784/S. 629, H.R. 2713) Trauma (H.R. 4365) Cybersecurity policy

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medical liability issues; continuing medical education; graduate medical education. H.R. 4499, S. 2758 PROP Act, H.R. 4365, S. 2932

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

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

Opioid Abuse; Opioid Education; Prescription Drugs. HR 953 Introduced February 12, 2015 by James Sensenbrenner, Jr. (R-WI) Comprehensive Addiction and Recovery Act of 2015. The bill amends the Public Health Service Act to authorize the Center for Substance Abuse Treatment to award grants to enable state substance abuse agencies, local governments, nonprofit organizations, and Indian tribes or tribal organizations that have a high rate of, or have had a rapid increase in, the use of heroin or other opioids to expand activities, including medication assisted treatment, for the treatment of addiction in the geographical areas affected. The Comprehensive Recovery Act, S. 524 was introduced by Sen. Sheldon Whitehouse (D-RI) and HR 953 to tackle the growing epidemic. HR 2805 Heroin and Prescription Opioid Abuse Prevention, Education and Enforcement Act of 2015 Introduced June 17, 2015 by Susan Brooks (R-IN). This bill requires the Department of Health and Human Services (HHS), in cooperation with the Department of Veteran Affairs, the Department of Defense, and the Drug Enforcement Administration (DEA) to convene a Pain Management Best Practices Inter-Agency Task Force to develop and study best practice for pain management and prescription of pain medication. HR 4499 Introduced February 9, 206 by Alex Mooney (R-VA) Promoting Responsible Opioid Prescribing Act of 2016. To amend title XVII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program, and for other purposes.

Client expense: $20,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Opioid Abuse; Opiod Education; Prescription Drugs HR 953 Introduced February 12, 2015 by James Sensenbrenner, JR. (R-WI) Comprehensive Addiction and Recovery Act of 2015 Overdoses from heroin,prescription drugs, and opioid pain relievers last year surpassed car accidents as the leading cause of injury-related deaths in America, according to the Centers for Disease Control. Deaths have reached their highest levels of the 21st century in 2014, the most recent year for which data is available, according to the National Institute on Drug Abuse. Heroin overdoses have more than tripled in the last five years, an issue receiving outsize attention nationally but especially during the presidential campaign season as New Hampshire has been one of the hardest-hit states. New legislation aims to tackle this epidemic. The Comprehensive Addiction and Recovery Act, S. 524 and H.R. 953, was introduced by Sen. Sheldon Whitehouse (D-RI) and Rep. Jim Sensenbrenner (R-WI5) and will receive a hearing on Thursday from the Senate Judiciary Committee. HR 2805 Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement-Act of 2015 Introduced June 17, 2015 by Susan Brooks (R-IN). This bill requires the Department of Health and Human Services (HHS), in cooperation with the Department of Veterans Affairs, the Department of Defense, and the Drug Enforcement Administration (DEA), to convene a Pain Management Best Practices Inter-Agency Task Force to develop and study best practices for pain management and prescription of pain medication. HR 4499 Introduced February 9, 2016 by Alex Mooney (R-VA) Promoting Responsible Opioid Prescribing Act of 2016. To amend Title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program, and for other purposes.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support S 258 and HR 169, Critical Access Hospital Relief Act, a bill that would remove the 96-hour physician certification requirement as a condition of payment for critical access hospitals (CAHs); Support HR 293, a bill to exempt certain journals and text books used in continuing medical education (CME) from manufacturer transparency reporting requirements; Participated in the Hearing, Examining the 340B Drug Pricing Program and submitted testimony about the 340B program, a federal drug discount program to Subcommittee members who will review the functionality of the program to ensure it is meeting its intended goals; HR 6, 21st Century Cures, a bill that accelerates the discovery and development of cures, and also includes provisions addressing interoperability of health IT and would provide additional money to NIH and the FDA; Two midnight discussion with several members of Congress; Support, Advancing Telehealth Opportunities in Medicare Telehealth, submitted a letter outlining the benefits of telehealth and showcases successful hospital and health system efforts. It also outlines barriers to greater use of telehealth; Submitted letter pertaining to interoperabilty within the hospital communities; Support S. 599, Improving Access to Emergency Psychiatric Care Act of 2015, legislation easing the shortage of psychiatric beds and extend and expand the CMS emergency psychiatric demonstration project; Comments on H.R.1458, BACPAC Act of 2015, a bill to amend title XVIII of the Social Security Act to provide bundled payments for post-acute care services under parts A and B of Medicare, and submitted a statement for a hearing on HR 1458 (re bundled payments for post-acute and other post-hospital services); Discussed Equity of Care Issues with Members of Congress; Advocate for funding by working with the Office of the Assistant Secretary for Preparedness and Response (ASPR) and Hospital Preparedness Program staff on ensuring adequate Ebola hospital funding; Working with the Centers for Disease Control and Prevention (CDC) on ongoing Ebola-related issues and guidance; Working with the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) to ensure that hospitals continue to be able to use blood glucose monitoring systems (BGMS) on hospitalized patients;Discussion of draft guidance on drug compounding and repackaging; Working with ASPR and CDC staff to define the impact of the Hospital Preparedness Program and Public Health Emergency Preparedness Program on improving health care system preparedness; Support efforts to advocate on Ebola within a discussion with FDA regarding impact on access to chest tubes regarding the Atrium Medical Corp and Maquet consent decree ; Advocate for regulatory approach in a discussion with White House staff regarding new initiative promoting bystander involvement in stopping hemorrhage in injured civilians; Attended a roundtable discussion on Opioid-related dependence, overdose, and death at HHS; Advocate for changes to The Care Planning Act, a bill that would provide for advanced illness care coordination services for Medicare beneficiaries; Support HR 2878 and S 1461,a bill to provide for the extension of the enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through 2015; Support S.799/HR 1462, Protecting Our Infants Act of 2015, a bill to combat the rise of prenatal opioid abuse and neonatal abstinence syndrome; Discussed S.1349, a bill that amends title XVIII (Medicare) of the Social Security Act to require a hospital or critical access hospital with an agreement with the Secretary of Health and Human Services to give each individual who receives observation services as an outpatient for more than 24 hours an adequate oral and written notification within 36 hours after beginning treatment; Supported expansions to Medicare reimbursement for telehealth along with changes to the Health Care Connect Fund; Comments on S.1648, Rural Emergency Acute Care Hospital Act of 2015, a bill to amend title XVIII of the Social Security Act to create a sustainable future for rural healthcare. Urged that HHS refrain from finalizing a stage 3 meaningful use rule; Advocate for Appropriate Surveyor Guidance on Calculated Hospitals in discussion about member concerns regarding remarks of CMS official that were confusing during a health lawyers association webinar; Discussion with CMS staff regarding proposed rule on establishing market-based payments for clinical laboratory tests; Discussion to rescind the proposed 2 percent cut to CY 2016 outpatient PPS conversion factor; Support H.R.2948, Medicare Telehealth Parity Act of 2015, a bill to amend title XVIII (Medicare) of the Social Security Act to expand telehealth coverage in three phases; Support HR 2646, Helping Families in Mental Health Crisis Act of 2015,A bill to make available needed psychiatric, psychological, and supportive services for individuals with mental illness and families in mental health crisis; Support HR 1604, Veterans Mental Health Care Access Act, a bill that expands access to mental health services for veterans; Support H.R. 3183, The Veterans Health Care Freedom Act, a bill which makes significant improvements to the Veterans Choice Program; Support S 1189 The Conrad State 30 and Physician Access Act, a bill that reauthorizes the Conrad 30 and makes other changes to the program to improve patient access to care; Discussed quality measurement, meaningful use and Conditions of Participation; Conversation with CMS about the IOM Vital Signs report and how its recommendations could make quality measurement more meaningful; Spoke with CMS urging the Agency to correct the misimpression that was created statements made during a National Association of Medical Staff Specialists webinar by a CMS employee; Discussion with CMS about proposals contained in the Inpatient Psychiatric Facility PPS proposed rule urging CMS not to finalize two quality measures; Meeting at CMMI to discuss CCJR; Discuss S. 2141the Transparent Ratings on Usability and Security to Transform Information Technology Act of 2015, the TRUST Act, a bill that includes a definition of information blocking and a framework to assess interoperability of certified health IT (a health IT ratings program); Support S.1461 and H.R. 2878 a bill to provide for the extension of the enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through 2015; Oppose S. 1648 Rural Emergency Acute Care Hospital ActTo establish an alternative payment model for CAHs and small, rural hospitals whereby they may transition to become a rural emergency hospital.; Oppose H.R. 3225 Save Rural Hospitals Act, a bill to amend titles XVIII and XIX of the Social Security Act to provide for enhanced payments to rural health care providers under the Medicare and Medicaid programs; Discuss S. 1945 Mental Health Reform Act of 2015, a bill to make available needed psychiatric, psychological, and supportive services for individuals with mental illness and families in mental health crisis. It would reauthorize certain federal mental health programs, revise the IMD exclusion, reform SAMHSA, and study parity in mental health laws. Support S. 1893, The Mental Health Awareness and Improvement Act of 2015, a bill to reauthorize and improve programs related to mental health and substance use disorders; Letter asking for modifications to H.R. 3298 Medicare Post-Acute Care Value-Based Purchasing (PAC VBP) Act of 2015, the legislation would establish a value-based purchasing program for LTCHs, IRFs, SNFs and HH agencies. Worked to streamline and improve quality measures; Discussed how to implement the framework in the National Academy of Medicines Vital Signs report to streamline and focus quality measures used in Medicare programs; Discussed Opioid prescribing guidelines with the CDC to provide feedback on the opioid prescribing guidelines they were developing; Discussion with CMS regarding CAH designation status, negative impact of Insurance Consolidations on Medicare Advantage and for modifications to Comprehensive Care for Joint Replacement (CJR) model regarding aspects of the proposed rule; Discussion with CMS about the Emergency Preparedness final rule; Discussion with CMS regarding the 0.2 percent reduction to hospitals payments under the Inpatient Prospective Payment System (PPS); Support S. 524, the Johnson amendment and the Collins amendment, Comprehensive Addiction and Recovery Act of 2016, a bill to authorize the Attorney General to award grants to address the national epidemics of prescription opioid abuse and heroin use; Support H.R. 4499, Promoting Responsible Opioid Prescribing Act of 2016, a bill to amend title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program; Support S. 2220, The Healthy Maternity and Obstetric Medicine Act or Healthy MOM Act guarantees maternity coverage for women who are enrolled in the exchanges established under the Affordable Care Act, as well as women who are covered by individual and group insurance plans and federal employee health benefit plans; Comments to House Ways and Means and Senate Finance Committees on how to improve the physician self-referral (Stark) law; Urged CMS to delay the April 2016 release of the hospital star ratings on the Hospital Compare Website; Supported House and Senate letters urging CMS to delay release of hospital star ratings on the Hospital Compare Website; Support H.R. 4771, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act, a bill that would reduce health care costs and promote access to quality, affordable health care for all Americans; Letter to Senate HELP Committee draft legislation addressing health information technology (IT) and electronic health records (EHRs); Comments to CMS regarding addressing section 603 of the BBA of 2015 in regulation; Comments to House Energy & Commerce Committee regarding section 603 of the BBA of 2015 as well as site neutral payment policies in general; Statement for the record to House Energy & Commerce Committee on MACRA implementation; Statement for the record to Senate Finance Committee on MACRA implementation; Comments to the Senate Finance Committee Chronic Care document -Conversations with the CDC related to their opioid guidelines for chronic pain as well as a patient education piece about opioids; Discussions with CMS about CAH designation status Health Care Issues; Discussions with Rep. Hudson about H.R. 4365/ S. 2932, the Protecting Patient Access to Emergency Medications Act , a bill to amend the Controlled Substances Act with regard to the provision of emergency medical services; Support H.R. 4650 and S. 2108, Preserving Patient Access to Post-Acute Hospital Care Act of 2016, a bill to amend title XVIII of the Social Security Act to provide for an extension of certain Medicare long-term care hospital payment rules; Supported efforts to encourage Congress to send CMS letters on addressing the issue of colocation of facilities within a hospital; Discussions with Members of Congress on the potential implementation of Unique Device Identification on claims forms; Sponsored a Hill briefing on innovations in post-acute care;Supported House and Senate letters to CMS asking for flexibility when interpreting section 603 of the BBA of 2015 in regulation; Support HR 5547, the Health Care Price Transparency Promotion Act of 2016, a bill to require the sharing of health care price information; Support HR 5273, the Helping Hospitals Improve Patient Care Act of 2016, a bill to address outstanding issues with section 603 of the BBA of 2015 and provide for a socioeconomic adjustment to the Hospital Readmissions Reduction Program; Supported a letter to CMS on implementation of Sec. 603 of the Bipartisan Budget Acts site neutral cuts for off-campus HOPDs; Support H. res. 699 promoting minority health awareness and supporting the goals and ideals of National Minority Health Month in April 2016; Support H.R.4641 - a bill 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; Support H.R. 4982, the Examining Opioid Treatment Infrastructure Act of 2016, a bill which would require the Government Accountability Office (GAO) to evaluate and report on the capacity, availability and need for inpatient and outpatient treatment for opioid use disorders in the United States; Supports H.R. 3680, the Co-Prescribing to Reduce Overdoses Act of 2015, a bill would establish federal grants to carry out co-prescribing of overdose reversal drugs in areas experiencing significant numbers of opioid overdoses and deaths; Support H.R. 3691, the Improving Treatment for Pregnant and Postpartum Women Act of 2015, a bill that would reauthorize essential residential treatment programs for pregnant and postpartum women and provide grants to states to address the growing epidemic of infants suffering from opioid dependency; Support H.R. 4978, the Nurturing and Supporting Healthy Babies Act, a bill which would require a GAO evaluation of neonatal abstinence syndrome and the availability of treatment for this condition in the nations Medicaid programs; Support H.R. 4599, the Reducing Unused Medications Act of 2016, a bill to permit partial filling of schedule II prescriptions under specific circumstances; Support H.R. 4976, the Opioid Review Modernization Act of 2016, a bill which would provide for more stringent Food and Drug Administration review of new opioids without abuse-deterrent properties, recommendations for labeling of pediatric opioids, and recommendations for prescriber education; Support the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016, a bill for achieving fair and sustainable drug pricing; Supporting full alignment of 42CFR substance use records confidentiality requirements with HIPAA privacy rule; Support S. 3173 EHR Regulatory Relief Act, a bill to amend title XVIII of the Social Security Act to provide for a 90-day EHR reporting period for the determination of whether an eligible professional or eligible hospital is a meaningful EHR user and to remove the all-or-nothing approach to meaningful use; Support for H.R. 5713, The Sustaining Healthcare Integrity and Fair Treatment Act of 2016, a bill that would extend 25% rule relief and provide targeted relief to certain LTCHs struggling to meet the new criteria standards; Support for H.R. 6174, the Closing Loopholes for Orphan Drugs Act, a bill to amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title.

Client expense: $4,970,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Communications Commission (FCC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office

Precision Medicine Act (S2713); General Pharmacy Issues (HR6/2713); opioid abuse (S524, HR953, HR2805, HR4499); specialty drug pricing

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

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

Opioid Abuse; Opioid Education; Prescription Drugs HR 953 Introduced February 12, 2015 by James Sensenbrenner, Jr. (R-WI) Comprehensive Addiction and Recovery Act of 2015 Overdoses from heroin, prescription drugs, and opioid pain relievers last year surpassed car accidents as the leading cause of injury-related death in America, according to the Centers for Disease Control. Deaths have reached their highest levels of the 21st century in 2014, the most recent year for which data is available, according to the National Institute on Drug Abuse. Heroin overdoses have more than tripled in the last five years, an issue receiving outsize attention nationally but especially during the presidential campaign season as New Hampshire has been one of the hardest-hit states. New legislation aims to tackle this epidemic. The Comprehensive Addiction and Recovery Act, S. 524 and H.R. 953, was introduced by Sen. Sheldon Whitehouse (D-RI) and Rep. Jim Sensenbrenner (R-WI5) and will receive a hearing on Thursday from the Senate Judiciary Committee. HR 2805 Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement -Act of 2015 Introduced June 17, 2915 by Susan Brooks (R-IN) This bill requires the Department of Health and Human Services (HHS), in cooperation with the Department of Veterans Affairs, the Department of Defense, and the Drug Enforcement Administration (DEA), to convene a Pain Management Best Practices Inter-Agency Task Force to develop and study best practices for pain management and prescription of pain medication. HR 4499 Introduced February 9, 2016 by Alex Mooney (R-VA) Promoting Responsible Opioid Prescribing Act of 2016. To amend title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program, and for other purposes.

Client expense: $2,160,000 · Firm income: Not reported

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

Opioid Abuse; Opiod Education; Prescription Drugs; Pharmaceutical Innovation. HR 953 Introduced February 12, 2015 by James Sensenbrenner, JR. (R-WI) Comprehensive Addiction and Recovery Act of 2015 Overdoses from heroin,prescription drugs, and opioid pain relievers last year surpassed car accidents as the leading cause of injury-related deaths in America, according to the Centers for Disease Control. Deaths have reached their highest levels of the 21st century in 2014, the most recent year for which data is available, according to the National Institute on Drug Abuse. Heroin overdoses have more than tripled in the last five years, an issue receiving outsize attention nationally but especially during the presidential campaign season as New Hampshire has been one of the hardest-hit states. New legislation aims to tackle this epidemic. The Comprehensive Addiction and Recovery Act, S. 524 and H.R. 953, was introduced by Sen. Sheldon Whitehouse (D-RI) and Rep. Jim Sensenbrenner (R-WI5) and will receive a hearing on Thursday from the Senate Judiciary Committee. HR 2805 Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement-Act of 2015 Introduced June 17, 2015 by Susan Brooks (R-IN). This bill requires the Department of Health and Human Services (HHS), in cooperation with the Department of Veterans Affairs, the Department of Defense, and the Drug Enforcement Administration (DEA), to convene a Pain Management Best Practices Inter-Agency Task Force to develop and study best practices for pain management and prescription of pain medication. HR 4499 Introduced February 9, 2016 by Alex Mooney (R-VA) Promoting Responsible Opioid Prescribing Act of 2016. To amend Title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program, and for other purposes.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support S 258 and HR 169, Critical Access Hospital Relief Act, a bill that would remove the 96-hour physician certification requirement as a condition of payment for critical access hospitals (CAHs); Support HR 293, a bill to exempt certain journals and text books used in continuing medical education (CME) from manufacturer transparency reporting requirements; Participated in the Hearing, Examining the 340B Drug Pricing Program and submitted testimony about the 340B program, a federal drug discount program to Subcommittee members who will review the functionality of the program to ensure it is meeting its intended goals; HR 6, 21st Century Cures, a bill that accelerates the discovery and development of cures, and also includes provisions addressing interoperability of health IT and would provide additional money to NIH and the FDA; Two midnight discussion with several members of Congress; Support, Advancing Telehealth Opportunities in Medicare Telehealth, submitted a letter outlining the benefits of telehealth and showcases successful hospital and health system efforts. It also outlines barriers to greater use of telehealth; Submitted letter pertaining to interoperabilty within the hospital communities; Support S. 599, Improving Access to Emergency Psychiatric Care Act of 2015, legislation easing the shortage of psychiatric beds and extend and expand the CMS emergency psychiatric demonstration project; Comments on H.R.1458, BACPAC Act of 2015, a bill to amend title XVIII of the Social Security Act to provide bundled payments for post-acute care services under parts A and B of Medicare, and submitted a statement for a hearing on HR 1458 (re bundled payments for post-acute and other post-hospital services); Discussed Equity of Care Issues with Members of Congress; Advocate for funding by working with the Office of the Assistant Secretary for Preparedness and Response (ASPR) and Hospital Preparedness Program staff on ensuring adequate Ebola hospital funding; Working with the Centers for Disease Control and Prevention (CDC) on ongoing Ebola-related issues and guidance; Working with the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) to ensure that hospitals continue to be able to use blood glucose monitoring systems (BGMS) on hospitalized patients;Discussion of draft guidance on drug compounding and repackaging; Working with ASPR and CDC staff to define the impact of the Hospital Preparedness Program and Public Health Emergency Preparedness Program on improving health care system preparedness; Support efforts to advocate on Ebola within a discussion with FDA regarding impact on access to chest tubes regarding the Atrium Medical Corp and Maquet consent decree ; Advocate for regulatory approach in a discussion with White House staff regarding new initiative promoting bystander involvement in stopping hemorrhage in injured civilians; Attended a roundtable discussion on Opioid-related dependence, overdose, and death at HHS; Advocate for changes to The Care Planning Act, a bill that would provide for advanced illness care coordination services for Medicare beneficiaries; Support HR 2878 and S 1461,a bill to provide for the extension of the enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through 2015; Support S.799/HR 1462, Protecting Our Infants Act of 2015, a bill to combat the rise of prenatal opioid abuse and neonatal abstinence syndrome; Discussed S.1349, a bill that amends title XVIII (Medicare) of the Social Security Act to require a hospital or critical access hospital with an agreement with the Secretary of Health and Human Services to give each individual who receives observation services as an outpatient for more than 24 hours an adequate oral and written notification within 36 hours after beginning treatment; Supported expansions to Medicare reimbursement for telehealth along with changes to the Health Care Connect Fund; Comments on S.1648, Rural Emergency Acute Care Hospital Act of 2015, a bill to amend title XVIII of the Social Security Act to create a sustainable future for rural healthcare. Urged that HHS refrain from finalizing a stage 3 meaningful use rule; Advocate for Appropriate Surveyor Guidance on Calculated Hospitals in discussion about member concerns regarding remarks of CMS official that were confusing during a health lawyers association webinar; Discussion with CMS staff regarding proposed rule on establishing market-based payments for clinical laboratory tests; Discussion to rescind the proposed 2 percent cut to CY 2016 outpatient PPS conversion factor; Support H.R.2948, Medicare Telehealth Parity Act of 2015, a bill to amend title XVIII (Medicare) of the Social Security Act to expand telehealth coverage in three phases; Support HR 2646, Helping Families in Mental Health Crisis Act of 2015,A bill to make available needed psychiatric, psychological, and supportive services for individuals with mental illness and families in mental health crisis; Support HR 1604, Veterans Mental Health Care Access Act, a bill that expands access to mental health services for veterans; Support H.R. 3183, The Veterans Health Care Freedom Act, a bill which makes significant improvements to the Veterans Choice Program; Support S 1189 The Conrad State 30 and Physician Access Act, a bill that reauthorizes the Conrad 30 and makes other changes to the program to improve patient access to care; Discussed quality measurement, meaningful use and Conditions of Participation; Conversation with CMS about the IOM Vital Signs report and how its recommendations could make quality measurement more meaningful; Spoke with CMS urging the Agency to correct the misimpression that was created statements made during a National Association of Medical Staff Specialists webinar by a CMS employee; Discussion with CMS about proposals contained in the Inpatient Psychiatric Facility PPS proposed rule urging CMS not to finalize two quality measures; Meeting at CMMI to discuss CCJR; Discuss S. 2141the Transparent Ratings on Usability and Security to Transform Information Technology Act of 2015, the TRUST Act, a bill that includes a definition of information blocking and a framework to assess interoperability of certified health IT (a health IT ratings program); Support S.1461 and H.R. 2878 a bill to provide for the extension of the enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through 2015; Oppose S. 1648 Rural Emergency Acute Care Hospital ActTo establish an alternative payment model for CAHs and small, rural hospitals whereby they may transition to become a rural emergency hospital.; Oppose H.R. 3225 Save Rural Hospitals Act, a bill to amend titles XVIII and XIX of the Social Security Act to provide for enhanced payments to rural health care providers under the Medicare and Medicaid programs; Discuss S. 1945 Mental Health Reform Act of 2015, a bill to make available needed psychiatric, psychological, and supportive services for individuals with mental illness and families in mental health crisis. It would reauthorize certain federal mental health programs, revise the IMD exclusion, reform SAMHSA, and study parity in mental health laws. Support S. 1893, The Mental Health Awareness and Improvement Act of 2015, a bill to reauthorize and improve programs related to mental health and substance use disorders; Letter asking for modifications to H.R. 3298 Medicare Post-Acute Care Value-Based Purchasing (PAC VBP) Act of 2015, the legislation would establish a value-based purchasing program for LTCHs, IRFs, SNFs and HH agencies. Worked to streamline and improve quality measures; Discussed how to implement the framework in the National Academy of Medicines Vital Signs report to streamline and focus quality measures used in Medicare programs; Discussed Opioid prescribing guidelines with the CDC to provide feedback on the opioid prescribing guidelines they were developing; Discussion with CMS regarding CAH designation status, negative impact of Insurance Consolidations on Medicare Advantage and for modifications to Comprehensive Care for Joint Replacement (CJR) model regarding aspects of the proposed rule; Discussion with CMS about the Emergency Preparedness final rule; Discussion with CMS regarding the 0.2 percent reduction to hospitals payments under the Inpatient Prospective Payment System (PPS); Support S. 524, the Johnson amendment and the Collins amendment, Comprehensive Addiction and Recovery Act of 2016, a bill to authorize the Attorney General to award grants to address the national epidemics of prescription opioid abuse and heroin use; Support H.R. 4499, Promoting Responsible Opioid Prescribing Act of 2016, a bill to amend title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program; Support S. 2220, The Healthy Maternity and Obstetric Medicine Act or Healthy MOM Act guarantees maternity coverage for women who are enrolled in the exchanges established under the Affordable Care Act, as well as women who are covered by individual and group insurance plans and federal employee health benefit plans; Comments to House Ways and Means and Senate Finance Committees on how to improve the physician self-referral (Stark) law; Urged CMS to delay the April 2016 release of the hospital star ratings on the Hospital Compare Website; Supported House and Senate letters urging CMS to delay release of hospital star ratings on the Hospital Compare Website; Support H.R. 4771, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act, a bill that would reduce health care costs and promote access to quality, affordable health care for all Americans; Letter to Senate HELP Committee draft legislation addressing health information technology (IT) and electronic health records (EHRs); Comments to CMS regarding addressing section 603 of the BBA of 2015 in regulation; Comments to House Energy & Commerce Committee regarding section 603 of the BBA of 2015 as well as site neutral payment policies in general; Statement for the record to House Energy & Commerce Committee on MACRA implementation; Statement for the record to Senate Finance Committee on MACRA implementation; Comments to the Senate Finance Committee Chronic Care document -Conversations with the CDC related to their opioid guidelines for chronic pain as well as a patient education piece about opioids; Discussions with CMS about CAH designation status Health Care Issues; Discussions with Rep. Hudson about H.R. 4365/ S. 2932, the Protecting Patient Access to Emergency Medications Act , a bill to amend the Controlled Substances Act with regard to the provision of emergency medical services; Support H.R. 4650 and S. 2108, Preserving Patient Access to Post-Acute Hospital Care Act of 2016, a bill to amend title XVIII of the Social Security Act to provide for an extension of certain Medicare long-term care hospital payment rules; Supported efforts to encourage Congress to send CMS letters on addressing the issue of colocation of facilities within a hospital; Discussions with Members of Congress on the potential implementation of Unique Device Identification on claims forms; Sponsored a Hill briefing on innovations in post-acute care;Supported House and Senate letters to CMS asking for flexibility when interpreting section 603 of the BBA of 2015 in regulation; Support HR 5547, the Health Care Price Transparency Promotion Act of 2016, a bill to require the sharing of health care price information; Support HR 5273, the Helping Hospitals Improve Patient Care Act of 2016, a bill to address outstanding issues with section 603 of the BBA of 2015 and provide for a socioeconomic adjustment to the Hospital Readmissions Reduction Program; Supported a letter to CMS on implementation of Sec. 603 of the Bipartisan Budget Acts site neutral cuts for off-campus HOPDs; Support H. res. 699 promoting minority health awareness and supporting the goals and ideals of National Minority Health Month in April 2016; Support H.R.4641 - a bill 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; Support H.R. 4982, the Examining Opioid Treatment Infrastructure Act of 2016, a bill which would require the Government Accountability Office (GAO) to evaluate and report on the capacity, availability and need for inpatient and outpatient treatment for opioid use disorders in the United States; Supports H.R. 3680, the Co-Prescribing to Reduce Overdoses Act of 2015, a bill would establish federal grants to carry out co-prescribing of overdose reversal drugs in areas experiencing significant numbers of opioid overdoses and deaths; Support H.R. 3691, the Improving Treatment for Pregnant and Postpartum Women Act of 2015, a bill that would reauthorize essential residential treatment programs for pregnant and postpartum women and provide grants to states to address the growing epidemic of infants suffering from opioid dependency; Support H.R. 4978, the Nurturing and Supporting Healthy Babies Act, a bill which would require a GAO evaluation of neonatal abstinence syndrome and the availability of treatment for this condition in the nations Medicaid programs; Support H.R. 4599, the Reducing Unused Medications Act of 2016, a bill to permit partial filling of schedule II prescriptions under specific circumstances; Support H.R. 4976, the Opioid Review Modernization Act of 2016, a bill which would provide for more stringent Food and Drug Administration review of new opioids without abuse-deterrent properties, recommendations for labeling of pediatric opioids, and recommendations for prescriber education; Support the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016, a bill for achieving fair and sustainable drug pricing; Supporting full alignment of 42CFR substance use records confidentiality requirements with HIPAA privacy rule; Support S. 3173 EHR Regulatory Relief Act, a bill to amend title XVIII of the Social Security Act to provide for a 90-day EHR reporting period for the determination of whether an eligible professional or eligible hospital is a meaningful EHR user and to remove the all-or-nothing approach to meaningful use; Support for H.R. 5713, The Sustaining Healthcare Integrity and Fair Treatment Act of 2016, a bill that would extend 25% rule relief and provide targeted relief to certain LTCHs struggling to meet the new criteria standards; Support for H.R. 6174, the Closing Loopholes for Orphan Drugs Act, a bill to amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title.

Client expense: $4,050,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Communications Commission (FCC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office

Medical liability reform (H.R. 836/S. 884, H.R. 4771) Mental health & opioid abuse policy (H.R. 2646, H.R. 4435, S. 1893, S. 1913, S. 524, S. 2680, S. 480, S. 2687, H.R. 4843, H.R. 4499/S. 2758, H.R. 3680, H.R. 3691, H.R. 4599, H.R. 4651, H.R. 4976, H.R. 4978, H.R. 4982, H.R. 4969) 340B discount drug program Chronic care policy Nurse education policy (H.R. 977/H.R. 1784/S. 629, H.R. 2713) Trauma (H.R. 4365) Cybersecurity policy

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Opioid Abuse; Opioid Education; Prescription Drugs, Pharmaceutical Innovation HR 953 Introduced February 12, 2015 by James Sensenbrenner, Jr. (R-WI) Comprehensive Addiction and Recovery Act of 2015 Overdoses from heroin, prescription drugs, and opioid pain relievers last year surpassed car accidents as the leading cause of injury-related death in America, according to the Centers for Disease Control. Death have reached their highest levels of the 21st Century in 2014, the most recent year for which data is available, according to the National Institute on Drug Abuse. Heroin overdoses have more than tripled in the last five years, an issue receiving outsize attention nationally but especially during the presidential campaign season as New Hampshire has been one of the hardest-hit states. New legislation aims to tackle this epidemic. The Comprehensive Addiction and Recovery Act, S. 524 and HR 953, was introduced by Sen. Sheldon Whitehouse (D-RI) and Rep. Jim Sensenbrenner (R-WI) and will receive a hearing on Thursday before the Judiciary Committee. HR 2805 Heroin and Prescription Opioid Abuse Prevention, Education and Enforcement Act of 2015 Introduced June 17, 2015 by Susan Brooks (R-IN) this bill requires the Department of Health and Human Services (HHS)in cooperation with the Department of Veterans Affairs, the Department of Defense, and the Drug Enforcement Administration (DEA), to convene a Pain Management Best Practices Inter-Agency Task Force to develop and study best practices for pain management and prescription of pain medication. HR 4499 Introduced February 9, 2016 by Alex Mooney (R-VA) Promoting Responsible Opioid Prescribing Act of 2016. To amend title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program and for other purposes.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issue: Educate congressional staff on academic medicines missions, including education, research, patient care, GME, workforce, and physician shortages in rural and urban communities. Issue: Support inclusion of socioeconomic status in Hospital Compare star ratings; delay public release of ratings until data is released and reviewed by hospital community. H.R. 1006/S. 2107, Building a Health Care Workforce for the Future Act Issue: Support bill to increase scholarship opportunities for medical students and encourage primary care workforce development Issue: Reauthorization of Title VII health professions programs Issue: Diversity of the health care workforce Issue: Training in substance abuse, pain management, womens health, and mental health in medical education Issue: Strategies to prevent, identify, and treat opioid dependence Issue: Concurrent and overlapping surgery practices S. 1455, TREAT Act Issue: Support legislation to expand cap on buprenorphine Issue: Provide comments on draft legislation to increase the safety of prescription drug use H.R. 4499, Promoting Responsible Opioid Prescribing Act of 2016 Issue: Support delinking the Hospital Consumer Assessment of Healthcare Providers and Systems surveys pain management questions from the Centers for Medicare and Medicaid Services calculations of hospital incentive payments under the Value-Based Purchasing Program. Issue: Implementation of 340B Drug Pricing Program and eligibility of offsite facilities under OPPS Issue: Educate Congress on the impact of the self-referral (Stark law) on health care payment and delivery system reform, and how to promote development of alternative payment models S. 2837/H.R. 2578, FY 2017 Commerce-Justice-Science Appropriations Issue: Support amendments to expand background checks on gun purchases and make it more difficult for known/suspected terrorists to purchase firearms. H.R. 3299, Strengthening Public Health Emergency Response Act of 2015 Issue: Support provisions to strengthen the Hospitals Preparedness Program Issue: Educate Congress on the role of Academic Medical Centers in emergency preparedness

Client expense: $595,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), White House Office

S. 3130, Independence at Home Act of 2016, all provisions S. 3220, Medicare Common Access Card Act of 2015, all provisions H.R. 3355, To amend title XVIII of the Social Security Act to allow physician assistants, nurse practitioners, and clinical nurse specialists to supervise cardiac, intensive cardiac, and pulmonary rehabilitation programs, all provisions S. 488, A bill to amend title XVIII of the Social Security Act to allow physician assistants, nurse practitioners, and clinical nurse specialists to supervise cardiac, intensive cardiac, and pulmonary rehabilitation programs, all provisions S. 1913, Stopping Medication Abuse and Protecting Seniors Act of 2015, all provisions H.R. 4442, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act, all provisions S. 2484, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act, all provisions S. 2141, Transparent Ratings on Usability and Security to Transform Information Technology (TRUST IT) Act of 2015, all provisions S. 1131, Medicare Diabetes Prevention Act of 2015, all provisions H.R. 976, Patient Access to Higher Quality Health Care Act of 2015, all provisions H.R. 2568, Fair Medical Audits Act of 2015, all provisions H.R. 4499, Promoting Responsible Opioid Prescribing (PROP) Act of 2016, all provisions S. 2758, Promoting Responsible Opioid Prescribing (PROP) Act of 2016, all provisions Medicare program: ACO Improvement Act of 2016 Medicare program: Medicare Access and CHIP Reauthorization Act (MACRA) implementation Medicare program: Merit-Based Incentive Payment System (MIPS) Medicare program: Part B Drug Demonstration Medicare program: Outpatient Prospective Payment - site of service, pain measures Medicare program: Advancing Care Information (ACI) Medicare program: Clinical Practice Improvement Activities (CPIA) Medicare program: Resource use Medicare program: Physician Fee Schedule Medicare program: Independent Payment Advisory Board (IPAB) Medicare program: Center for Medicare and Medicaid Innovation (CMMI) Medicare program: Global surgical codes Medicare program: Mobility payment add-on Medicare program: Episode groups Medicare program: Patient relationship codes Medicare program: Composite scoring and performance adjustments Medicare program: Feedback reports Medicare program: Alternative payment models (APMs) Medicare program: Relative Value Scale Update Committee (RUC) Medicare program: Health Insurance Portability and Accountability Act (HIPAA) Medicare program: Electronic health record (EHR) interoperability Medicare program: EHR/Meaningful Use Medicare program: EHR Certification Medicare program: ICD-10 Medicare program: Medicare appeals Medicare program: Medicare Pre-Diabetes Program Medicare program: Unique Device Identifier Medicare program: CPT Medicare program: Social Security Number Removal Initiative Medicare program: Telehealth Medicare program: In-office Ancillary Services Exception Medicare program: Value-based Payment Modifier Medicare program: Graduate Medical Education Medicare program: Physician Quality Reporting System (PQRS) Medicare program: Prescription drug diversion Medicare program: Physician data Medicare program: Physician-owned hospital moratorium Medicare program: Smart Card technology Medicare program: PECOS/Medicare Enrollment Medicare program: Diabetes Prevention Program fees

Client expense: $3,870,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Veterans Affairs, Dept of (VA), White House Office

H.R. 1270, Restoring Access to Medication Act of 2015, all provisions S. 709, Restoring Access to Medication Act of 2015, all provisions H.R. 3926, Gun Violence Research Act, all provisions S. 524, Comprehensive Addiction and Recovery Act (CARA) of 2016, all provisions S. 2978, Protecting Continuing Physician Education and Patient Care Act, all provisions 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, all provisions S. 1945, Mental Health Reform Act of 2015, all provisions H.R. 2646, Helping Families in Mental Health Crisis Act of 2016, all provisions H.R. 1217, Public Safety and Second Amendment Rights Protection Act of 2015, all provisions H.R. 1725, National All Schedules Prescription Electronic Reporting Reauthorization (NASPER) Act of 2015, all provisions S. 480, National All Schedules Prescription Electronic Reporting Reauthorization (NASPER) Act of 2016, all provisions H.R. 2536, The Recovery Enhancement for Addiction Treatment (TREAT) Act, all provisions S. 1455, The Recovery Enhancement for Addiction Treatment (TREAT) Act, all provisions H.R. 4499, Promoting Responsible Opioid Prescribing (PROP) Act of 2016, all provisions S. 2758, Promoting Responsible Opioid Prescribing (PROP) Act of 2016, all provisions H.R. 1877, Mental Health First Aid Act of 2016, all provisions H.R. 1217, Public Safety and Second Amendment Rights Protection Act of 2015, all provisions H.R. 1209, Improving Access to Maternity Care Act, all provisions S. 3077, Marijuana Effective Drug Studies (MEDS) Act of 2016, all provisions S. 2141, Transparent Ratings on Usability and Security to Transform Information Technology (TRUST IT) Act of 2015, all provisions Health Savings Accounts - Prescription requirements for over-the-counter medications Opioid Abuse Prescription Drug Diversion Telemedicine - Interstate Medical Licensure Compact Gun Violence Zika Virus Funding Health Insurance Portability and Accountability Act (HIPAA), audits and physician education Electronic health record (EHR) interoperability Physician Payment Sunshine 21st Century Cures, Innovations Personalized Medicine Initiative Laboratory developed testing PrecisionFDA Diabetes Prevention Health Data Security Next Generation Sequencing Drug Compounding

Client expense: $3,870,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Veterans Affairs, Dept of (VA), White House Office

Opioid Abuse; Opioid Education; Prescription Drugs; Pharmaceutical Innovation HR 953 Introduced February 12, 2015 by James Sensenbrenner, Jr. (R-WI) Comprehensive Addiction and Recovery Act of 2015. The bill amends the Public Health Service Act to authorize the Center for Substance Abuse Treatment to award grants to enable state substance abuse agencies, local governments, nonprofit organizations, and Indian tribes or tribal organizations that have a high rate of, or have had a rapid increase in, the use of heroin or other opioids to expand activities, including medication assisted treatment, for the treatment of addiction in the geographical areas affected. The Comprehensive Recovery Act, S. 524 was introduced by Sen. Sheldon Whitehouse (D-RI) and HR 953 to tackle the growing epidemic. HR 2805 Heroin and Prescription Opioid Abuse Prevention, Education and Enforcement Act of 2015 Introduced June 17, 2015 by Susan Brooks (R-IN). This bill requires the Department of Health and Human Services (HHS), in cooperation with the Department of Veteran Affairs, the Department of Defense, and the Drug Enforcement Administration (DEA) to convene a Pain Management Best Practices Inter-Agency Task Force to develop and study best practice for pain management and prescription of pain medication. HR 4499 Introduced February 9, 206 by Alex Mooney (R-VA) Promoting Responsible Opioid Prescribing Act of 2016. To amend title XVII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program, and for other purposes.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Opioid Abuse; Opioid Education; Prescription Drugs; Pharmaceutical Innovation HR 953 Introduced February 12, 2015 by James Sensenbrenner, Jr. (R-WI) Comprehensive Addiction and Recovery Act of 2015 Overdoses from heroin, prescription drugs, and opioid pain relievers last year surpassed car accidents as the leading cause of injury-related death in America, according to the Centers for Disease Control. Deaths have reached their highest levels of the 21st century in 2014, the most recent year for which data is available, according to the National Institute on Drug Abuse. Heroin overdoses have more than tripled in the last five years, an issue receiving outsize attention nationally but especially during the presidential campaign season as New Hampshire has been one of the hardest-hit states. New legislation aims to tackle this epidemic. The Comprehensive Addiction and Recovery Act, S. 524 and H.R. 953, was introduced by Sen. Sheldon Whitehouse (D-RI) and Rep. Jim Sensenbrenner (R-WI5) and will receive a hearing on Thursday from the Senate Judiciary Committee. HR 2805 Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement -Act of 2015 Introduced June 17, 2915 by Susan Brooks (R-IN) This bill requires the Department of Health and Human Services (HHS), in cooperation with the Department of Veterans Affairs, the Department of Defense, and the Drug Enforcement Administration (DEA), to convene a Pain Management Best Practices Inter-Agency Task Force to develop and study best practices for pain management and prescription of pain medication. HR 4499 Introduced February 9, 2016 by Alex Mooney (R-VA) Promoting Responsible Opioid Prescribing Act of 2016. To amend title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program, and for other purposes.

Client expense: $2,150,000 · Firm income: Not reported

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

Health Insurance Coverage, Genetic Testing (general); Health Disparities (general); Emergency Contraception (general); Health Care Reform Implementation; Substance Use Disorder (general); HIV Screening (general); Gynecologic Cancer (general); Gynecologic devices (general); Breast Cancer (general); Breastfeeding (general); Medical Liability Reform (general); Health IT (general); Prematurity (general); Disparities (general); Prevention and Public Health Fund (general); Maternal Mortality and Morbidity (general); Imaging (general); Graduate Medical Education (general); Quality Improvement Measurement (general); Contraception (general); Postpartum Depression (general); CMS Provider Penalties (general); Preeclampsia (general); National Health Service Corps (general); Abortion (general); Indian Health (general); Teaching Health Centers (general); Research in Pregnant and Breastfeeding Women (general); Healthy Start (general); H.R.4695/S. 466, Quality Care for Moms and Babies Act; H.R. 3865/S.2542, Cradle Act;; H.R. 865/S. 3101, Good Samaritan Health Professionals Act; H.R. 4774, Training Tomorrows Doctors Today Act; H.R. 4771, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016; H.R. 1209/S.628 Improving Access to Maternity Care Act; Implementation of H.R. 1462/S. 799, Protecting our Infants Act; H.R. 3691/S. 2226, Improving Treatment for Pregnant and Postpartum Women Act; H.R. 448/S.217, Women's Health Protection Act of 2015; H.R. 2972, Equal Access to Abortion Coverage in Health Insurance (EACH Woman) Act; H.Res. 461, Establishing a Select Investigative Panel of the Committee on Energy and Commerce; Fetal Tissue Research (General); H.R. 3706/S.1911, Reach Every Mother and Child Act of 2016; H.Res. 558/S.Res. 327, Condemning Violence That Targets Healthcare for Women; S. 304, Conscience Protection Act; H.R. 3504, Born-Alive Abortion Survivors Protection Act; Hyde Amendment (General); Senate Biomedical Innovations Packages (general); S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act; S.2742, Promoting Biomedical Research and Public Health for Patients Act; H.R. 6, 21st Century Cures Act; H.R. 3656/S. 2100, Tobacco to 21 Act; H.R. 3652/S. 674, 21st Century Womens Health Act; S. 1532, Affordability is Access Act; H.R. 5746, Birth Control Privacy Act; H.R. 2058, FDA Deeming Authority Clarification Act of 2015; H.R. 3441, Accurate Education for Prenatal Screenings Act; H.R. 3235/S. 2311, Bringing Postpartum Depression Out of the Shadows Act; Shackling During Pregnancy (general); and H.R. 3539, Reinvigorating Antibiotic and Diagnostic Innovation Act; H.R. 5369, Healthy Start Reauthorization Act; S. 3070, Hygiene Assistance for Families of Infants and Toddlers Act of 2016; H.R. 5219 Safe Medications for Moms and Babies Act of 2016; H.R. 953/S. 524, Comprehensive Addiction and Recovery Act; H.R. 2646, Helping Families in Mental Health Crisis Act; S. 2680, Mental Health Reform Act; H.R. 3537, Synthetic Drug Control Act; H.R. 4499/S. 2758, Promoting Responsible Opioid Prescribing (PROP) Act; H.R. 4874, Prevent Abuse by Using Interstate Exchange Act; H.R. 2805/S. 1134, Heroin and Prescription Opioid Abuse, Prevention, Education, and Enforcement Act; H.R. 2654/S. 1512, Pregnant Workers Fairness Act; H.R. 1706/S.2765, Real Education for Healthy Youth Act; H.R. 5065/ S. 3299 Bottles and Breastfeeding Equipment Screening Act; H.R. 6010, Zika Pregnancy and Infant Registry Act.

Client expense: $436,321 · Firm income: Not reported

Government targets: Administration for Children & Families (ACF), Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, U.S. Agency for International Development (USAID), White House Office

General Pharmacy Issues (HR6/2713); opioid abuse (S524, HR953, HR2805, HR4499); specialty drug pricing

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

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

Medical liability issues; continuing medical education; graduate medical education. H.R. 4499, S. 2758 PROP Act, H.R. 4365, S. 2932

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

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

Increasing Competition in Pharmaceuticals Act (S. 2615); provisions related to hospital pharmacy operations. Promoting Responsible Opioid Prescribing Act of 2016 (H.R. 4499); all provisions generally.

Client expense: $170,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support S 258 and HR 169, Critical Access Hospital Relief Act, a bill that would remove the 96-hour physician certification requirement as a condition of payment for critical access hospitals (CAHs); Support HR 293, a bill to exempt certain journals and text books used in continuing medical education (CME) from manufacturer transparency reporting requirements; Participated in the Hearing, Examining the 340B Drug Pricing Program and submitted testimony about the 340B program, a federal drug discount program to Subcommittee members who will review the functionality of the program to ensure it is meeting its intended goals; HR 6, 21st Century Cures, a bill that accelerates the discovery and development of cures, and also includes provisions addressing interoperability of health IT and would provide additional money to NIH and the FDA; Two midnight discussion with several members of Congress; Support, Advancing Telehealth Opportunities in Medicare Telehealth, submitted a letter outlining the benefits of telehealth and showcases successful hospital and health system efforts. It also outlines barriers to greater use of telehealth; Submitted letter pertaining to interoperabilty within the hospital communities; Support S. 599, Improving Access to Emergency Psychiatric Care Act of 2015, legislation easing the shortage of psychiatric beds and extend and expand the CMS emergency psychiatric demonstration project; Comments on H.R.1458, BACPAC Act of 2015, a bill to amend title XVIII of the Social Security Act to provide bundled payments for post-acute care services under parts A and B of Medicare, and submitted a statement for a hearing on HR 1458 (re bundled payments for post-acute and other post-hospital services); Discussed Equity of Care Issues with Members of Congress; Advocate for funding by working with the Office of the Assistant Secretary for Preparedness and Response (ASPR) and Hospital Preparedness Program staff on ensuring adequate Ebola hospital funding; Working with the Centers for Disease Control and Prevention (CDC) on ongoing Ebola-related issues and guidance; Working with the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) to ensure that hospitals continue to be able to use blood glucose monitoring systems (BGMS) on hospitalized patients;Discussion of draft guidance on drug compounding and repackaging; Working with ASPR and CDC staff to define the impact of the Hospital Preparedness Program and Public Health Emergency Preparedness Program on improving health care system preparedness; Support efforts to advocate on Ebola within a discussion with FDA regarding impact on access to chest tubes regarding the Atrium Medical Corp and Maquet consent decree ; Advocate for regulatory approach in a discussion with White House staff regarding new initiative promoting bystander involvement in stopping hemorrhage in injured civilians; Attended a roundtable discussion on Opioid-related dependence, overdose, and death at HHS; Advocate for changes to The Care Planning Act, a bill that would provide for advanced illness care coordination services for Medicare beneficiaries; Support HR 2878 and S 1461,a bill to provide for the extension of the enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through 2015; Support S.799/HR 1462, Protecting Our Infants Act of 2015, a bill to combat the rise of prenatal opioid abuse and neonatal abstinence syndrome; Discussed S.1349, a bill that amends title XVIII (Medicare) of the Social Security Act to require a hospital or critical access hospital with an agreement with the Secretary of Health and Human Services to give each individual who receives observation services as an outpatient for more than 24 hours an adequate oral and written notification within 36 hours after beginning treatment; Supported expansions to Medicare reimbursement for telehealth along with changes to the Health Care Connect Fund; Comments on S.1648, Rural Emergency Acute Care Hospital Act of 2015, a bill to amend title XVIII of the Social Security Act to create a sustainable future for rural healthcare. Urged that HHS refrain from finalizing a stage 3 meaningful use rule; Advocate for Appropriate Surveyor Guidance on Calculated Hospitals in discussion about member concerns regarding remarks of CMS official that were confusing during a health lawyers association webinar; Discussion with CMS staff regarding proposed rule on establishing market-based payments for clinical laboratory tests; Discussion to rescind the proposed 2 percent cut to CY 2016 outpatient PPS conversion factor; Support H.R.2948, Medicare Telehealth Parity Act of 2015, a bill to amend title XVIII (Medicare) of the Social Security Act to expand telehealth coverage in three phases; Support HR 2646, Helping Families in Mental Health Crisis Act of 2015,A bill to make available needed psychiatric, psychological, and supportive services for individuals with mental illness and families in mental health crisis; Support HR 1604, Veterans Mental Health Care Access Act, a bill that expands access to mental health services for veterans; Support H.R. 3183, The Veterans Health Care Freedom Act, a bill which makes significant improvements to the Veterans Choice Program; Support S 1189 The Conrad State 30 and Physician Access Act, a bill that reauthorizes the Conrad 30 and makes other changes to the program to improve patient access to care; Discussed quality measurement, meaningful use and Conditions of Participation; Conversation with CMS about the IOM Vital Signs report and how its recommendations could make quality measurement more meaningful; Spoke with CMS urging the Agency to correct the misimpression that was created statements made during a National Association of Medical Staff Specialists webinar by a CMS employee; Discussion with CMS about proposals contained in the Inpatient Psychiatric Facility PPS proposed rule urging CMS not to finalize two quality measures; Meeting at CMMI to discuss CCJR; Discuss S. 2141the Transparent Ratings on Usability and Security to Transform Information Technology Act of 2015, the TRUST Act, a bill that includes a definition of information blocking and a framework to assess interoperability of certified health IT (a health IT ratings program); Support S.1461 and H.R. 2878 a bill to provide for the extension of the enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through 2015; Oppose S. 1648 Rural Emergency Acute Care Hospital ActTo establish an alternative payment model for CAHs and small, rural hospitals whereby they may transition to become a rural emergency hospital.; Oppose H.R. 3225 Save Rural Hospitals Act, a bill to amend titles XVIII and XIX of the Social Security Act to provide for enhanced payments to rural health care providers under the Medicare and Medicaid programs; Discuss S. 1945 Mental Health Reform Act of 2015, a bill to make available needed psychiatric, psychological, and supportive services for individuals with mental illness and families in mental health crisis. It would reauthorize certain federal mental health programs, revise the IMD exclusion, reform SAMHSA, and study parity in mental health laws. Support S. 1893, The Mental Health Awareness and Improvement Act of 2015, a bill to reauthorize and improve programs related to mental health and substance use disorders; Letter asking for modifications to H.R. 3298 Medicare Post-Acute Care Value-Based Purchasing (PAC VBP) Act of 2015, the legislation would establish a value-based purchasing program for LTCHs, IRFs, SNFs and HH agencies. Worked to streamline and improve quality measures; Discussed how to implement the framework in the National Academy of Medicines Vital Signs report to streamline and focus quality measures used in Medicare programs; Discussed Opioid prescribing guidelines with the CDC to provide feedback on the opioid prescribing guidelines they were developing; Discussion with CMS regarding CAH designation status, negative impact of Insurance Consolidations on Medicare Advantage and for modifications to Comprehensive Care for Joint Replacement (CJR) model regarding aspects of the proposed rule; Discussion with CMS about the Emergency Preparedness final rule; Discussion with CMS regarding the 0.2 percent reduction to hospitals payments under the Inpatient Prospective Payment System (PPS); Support S. 524, the Johnson amendment and the Collins amendment, Comprehensive Addiction and Recovery Act of 2016, a bill to authorize the Attorney General to award grants to address the national epidemics of prescription opioid abuse and heroin use; Support H.R. 4499, Promoting Responsible Opioid Prescribing Act of 2016, a bill to amend title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program; Support S. 2220, The Healthy Maternity and Obstetric Medicine Act or Healthy MOM Act guarantees maternity coverage for women who are enrolled in the exchanges established under the Affordable Care Act, as well as women who are covered by individual and group insurance plans and federal employee health benefit plans; Comments to House Ways and Means and Senate Finance Committees on how to improve the physician self-referral (Stark) law; Urged CMS to delay the April 2016 release of the hospital star ratings on the Hospital Compare Website; Supported House and Senate letters urging CMS to delay release of hospital star ratings on the Hospital Compare Website; Support H.R. 4771, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act, a bill that would reduce health care costs and promote access to quality, affordable health care for all Americans; Letter to Senate HELP Committee draft legislation addressing health information technology (IT) and electronic health records (EHRs); Comments to CMS regarding addressing section 603 of the BBA of 2015 in regulation; Comments to House Energy & Commerce Committee regarding section 603 of the BBA of 2015 as well as site neutral payment policies in general; Statement for the record to House Energy & Commerce Committee on MACRA implementation; Statement for the record to Senate Finance Committee on MACRA implementation; Comments to the Senate Finance Committee Chronic Care document -Conversations with the CDC related to their opioid guidelines for chronic pain as well as a patient education piece about opioids; Discussions with CMS about CAH designation status Health Care Issues; Discussions with Rep. Hudson about H.R. 4365/ S. 2932, the Protecting Patient Access to Emergency Medications Act , a bill to amend the Controlled Substances Act with regard to the provision of emergency medical services; Support H.R. 4650 and S. 2108, Preserving Patient Access to Post-Acute Hospital Care Act of 2016, a bill to amend title XVIII of the Social Security Act to provide for an extension of certain Medicare long-term care hospital payment rules; Supported efforts to encourage Congress to send CMS letters on addressing the issue of colocation of facilities within a hospital; Discussions with Members of Congress on the potential implementation of Unique Device Identification on claims forms; Sponsored a Hill briefing on innovations in post-acute care;Supported House and Senate letters to CMS asking for flexibility when interpreting section 603 of the BBA of 2015 in regulation; Support HR 5547, the Health Care Price Transparency Promotion Act of 2016, a bill to require the sharing of health care price information; Support HR 5273, the Helping Hospitals Improve Patient Care Act of 2016, a bill to address outstanding issues with section 603 of the BBA of 2015 and provide for a socioeconomic adjustment to the Hospital Readmissions Reduction Program; Supported a letter to CMS on implementation of Sec. 603 of the Bipartisan Budget Acts site neutral cuts for off-campus HOPDs; Support H. res. 699 promoting minority health awareness and supporting the goals and ideals of National Minority Health Month in April 2016; Support H.R.4641 - a bill 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; Support H.R. 4982, the Examining Opioid Treatment Infrastructure Act of 2016, a bill which would require the Government Accountability Office (GAO) to evaluate and report on the capacity, availability and need for inpatient and outpatient treatment for opioid use disorders in the United States; Supports H.R. 3680, the Co-Prescribing to Reduce Overdoses Act of 2015, a bill would establish federal grants to carry out co-prescribing of overdose reversal drugs in areas experiencing significant numbers of opioid overdoses and deaths; Support H.R. 3691, the Improving Treatment for Pregnant and Postpartum Women Act of 2015, a bill that would reauthorize essential residential treatment programs for pregnant and postpartum women and provide grants to states to address the growing epidemic of infants suffering from opioid dependency; Support H.R. 4978, the Nurturing and Supporting Healthy Babies Act, a bill which would require a GAO evaluation of neonatal abstinence syndrome and the availability of treatment for this condition in the nations Medicaid programs; Support H.R. 4599, the Reducing Unused Medications Act of 2016, a bill to permit partial filling of schedule II prescriptions under specific circumstances; Support H.R. 4976, the Opioid Review Modernization Act of 2016, a bill which would provide for more stringent Food and Drug Administration review of new opioids without abuse-deterrent properties, recommendations for labeling of pediatric opioids, and recommendations for prescriber education; Support the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016, a bill for achieving fair and sustainable drug pricing; Supporting full alignment of 42CFR substance use records confidentiality requirements with HIPAA privacy rule.

Client expense: $4,690,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Communications Commission (FCC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office

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

Opioid Abuse; Opiod Education; Prescription Drugs; Pharmaceutical Innovation. HR 953 Introduced February 12, 2015 by James Sensenbrenner, JR. (R-WI) Comprehensive Addiction and Recovery Act of 2015 Overdoses from heroin,prescription drugs, and opioid pain relievers last year surpassed car accidents as the leading cause of injury-related deaths in America, accordiing to the Centers for Disease Control. Deaths have reached their highest levels of the 21st century in 2014, the most recent year for which data is available, according to the National Institute on Drug Abuse. Heroin overdoses have more than tripled in the last five years, an issue receiving outsize attention nationally but especially during the presidential campaign season as New Hampshire has been one of the hardest-hit states. New legislation aims to tackle this epidemic. The Comprehensive Addiction and Recovery Act, S. 524 and H.R. 953, was introduced by Sen. Sheldon Whitehouse (D-RI) and Rep. Jim Sensenbrenner (R-WI5) and will receive a hearing on Thursday from the Senate Judiciary Committee. HR 2805 Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement-Act of 2015 Introduced June 17, 2015 by Susan Brooks (R-IN). This bill requires the Department of Health and Human Services (HHS), in cooperation with the Department of Veterans Affairs, the Department of Defense, and the Drug Enforcement Administration (DEA), to convene a Pain Management Best Practices Inter-Agency Task Force to develop and study best practices for pain management and prescription of pain medication. HR 4499 Introduced February 9, 2016 by Alex Mooney (R-VA) Promoting Responsible Opioid Prescribing Act of 2016. To amend Title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program, and for other purposes.

Client expense: $8,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issue: Educate congressional staff on academic medicines missions, including education, research, patient care, GME, workforce, and physician shortages in rural and urban communities. Issue: Support inclusion of socioeconomic status in Hospital Compare star ratings; delay public release of ratings until data is released and reviewed by hospital community. H.R. 1006/S. 2107, Building a Health Care Workforce for the Future Act Issue: Support bill to increase scholarship opportunities for medical students and encourage primary care workforce development Issue: Reauthorization of Title VII health professions programs Issue: Diversity of the health care workforce Issue: Training in substance abuse, pain management, womens health, and mental health in medical education Issue: Strategies to prevent, identify, and treat opioid dependence Issue: Concurrent and overlapping surgery practices S. 1455, TREAT Act Issue: Support legislation to expand cap on buprenorphine H.R. 4499, Promoting Responsible Opioid Prescribing Act of 2016 Issue: Support delinking the Hospital Consumer Assessment of Healthcare Providers and Systems surveys pain management questions from the Centers for Medicare and Medicaid Services calculations of hospital incentive payments under the Value-Based Purchasing Program. Issue: Implementation of 340B Drug Pricing Program Issue: Educate Congress on the impact of the self-referral (Stark law) on health care payment and delivery system reform, and how to promote development of alternative payment models S. 2837/H.R. 2578, FY 2017 Commerce-Justice-Science Appropriations Issue: Support amendments to expand background checks on gun purchases and make it more difficult for known/suspected terrorists to purchase firearms. H.R. 3299, Strengthening Public Health Emergency Response Act of 2015 Issue: Support provisions to strengthen the Hospitals Preparedness Program Issue: Educate Congress on the role of Academic Medical Centers in emergency preparedness

Client expense: $736,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), White House Office

H.R. 4499, Promoting Responsible Opioid Prescribing (PROP) Act of 2016, all provisions S. 2758, Promoting Responsible Opioid Prescribing (PROP) Act of 2016, all provisions H.R. 976, Patient Access to Higher Quality Health Care Act of 2015, all provisions H.R. 5273, Helping Hospitals Improve Patient Care Act of 2016, all provisions H.R. 2977, Furthering Access to Stroke Telemedicine (FAST) Act, all provisions H.R. 21102, Medicare Diabetes Prevention Act of 2015, all provisions S. 1131, Medicare Diabetes Prevention Act of 2015, all provisions H.R. 1470, SGR Repeal and Medicare Provider Payment Modernization Act of 2015, provisions relating to delivery and payment reform S. 810, SGR Repeal and Medicare Provider Payment Modernization Act of 2015, provisions relating to delivery and payment reform H.R. 1190, Protecting Seniors' Access to Medicare Act of 2015, all provisions H.R. 4442, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act, all provisions S. 2484, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act, all provisions S. 1913, Stopping Medication Abuse and Protecting Seniors Act of 2015, all provisions H.R. 1608, Lymphedema Treatment Act, all provisions S. 2373, Lymphedema Treatment Act, all provisions S. 2943, National Defense Authorization Act for Fiscal Year 2017, provisions relating to Telemedicine and licensure Medicare program: Diabetes prevention Medicare program: IPAB Repeal Medicare program: Medicare Access and CHIP Reauthorization Act (MACRA) Implementation Medicare program: MACRA physician compliance flexibility Medicare program: Quality Payment Program (QPP) Medicare program: Protecting Access to Medicare Act (PAMA) implementation Medicare program: Merit-Based Incentive Payment System (MIPS) Medicare program: Value-Based Modifier (VBM) Medicare program: Advancing Care Information (ACI) score Medicare program: Clinical Practice Improvement Activities (CPIAs) Medicare program: Resource Use Medicare program: Alternative Payment Models (APMs) Medicare program: Physician Quality Reporting System (PQRS) Medicare program: Graduate Medical Education (GME) Medicare program: Prescription Drug Diversion/Opioid abuse Medicare program: Physician data Medicare program: Adding unique device identifier to billing form Medicare program: Physician-owned hospital moratorium Medicare program: Physician Office-based Labs (POLS) Medicare program: EHR/Meaningful Use Medicare program: Sunshine Act Medicare program: Part B Drug Demonstration/Reimbursement Medicare program: In-Office Ancillary Services Exception Medicare program: Provider networks adequacy and balance billing Medicare program: AHIP-CMS Core Measure activity Medicare program: Comprehensive joint replacement Medicare program: Chronic care Medicare program: Home health prior authorization Medicare program: Telehealth Medicare program: Clinical Trials - insurance coverage improvements Medicare program: Coverage policy Medicare program: Program Integrity/Provider Enrollment Medicare and Medicaid programs: EHR interoperability/digital health Medicaid program: State Medicaid cuts

Client expense: $4,310,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Indian Health Service, Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Veterans Affairs, Dept of (VA), White House Office

Opioid Abuse; Opioid Education; Prescription Drugs; Pharmaceutical Innovation HR 953 Introduced February 12, 2015 by James Sensenbrenner, Jr. (R-WI) Comprehensive Addiction and Recovery Act of 2015 Overdoses from heroin, prescription drugs, and opioid pain relievers last year surpassed car accidents as the leading cause of injury-related death in America, according to the Centers for Disease Control. Deaths have reached their highest levels of the 21st century in 2014, the most recent year for which data is available, according to the National Institute on Drug Abuse. Heroin overdoses have more than tripled in the last five years, an issue receiving outsize attention nationally but especially during the presidential campaign season as New Hampshire has been one of the hardest-hit states. New legislation aims to tackle this epidemic. The Comprehensive Addiction and Recovery Act, S. 524 and H.R. 953, was introduced by Sen. Sheldon Whitehouse (D-RI) and Rep. Jim Sensenbrenner (R-WI5) and will receive a hearing on Thursday from the Senate Judiciary Committee. HR 2805 Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement -Act of 2015 Introduced June 17, 2915 by Susan Brooks (R-IN) This bill requires the Department of Health and Human Services (HHS), in cooperation with the Department of Veterans Affairs, the Department of Defense, and the Drug Enforcement Administration (DEA), to convene a Pain Management Best Practices Inter-Agency Task Force to develop and study best practices for pain management and prescription of pain medication. HR 4499 Introduced February 9, 2016 by Alex Mooney (R-VA) Promoting Responsible Opioid Prescribing Act of 2016. To amend title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program, and for other purposes.

Client expense: $2,180,000 · Firm income: Not reported

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

Opioid Abuse; Opioid Education; Prescription Drugs, Pharmaceutical Innovation HR 953 Introduced February 12, 2015 by James Sensenbrenner, Jr. (R-WI) Comprehensive Addiction and Recovery Act of 2015 Overdoses from heroin, prescription drugs, and opioid pain relievers last year surpassed car accidents as the leading cause of injury-related death in America, according to the Centers for Disease Control. Death have reached their highest levels of the 21st Century in 2014, the most recent year for which data is available, according to the National Institute on Drug Abuse. Heroin overdoses have more than tripled in the last five years, an issue receiving outsize attention nationally but especially during the presidential campaign season as New Hampshire has been one of the hardest-hit states. New legislation aims to tackle this epidemic. The Comprehensive Addiction and Recovery Act, S. 524 and HR 953, was introduced by Sen. Sheldon Whitehouse (D-RI) and Rep. Jim Sensenbrenner (R-WI) and will receive a hearing on Thursday before the Judiciary Committee. HR 2805 Heroin and Prescription Opioid Abuse Prevention, Education and Enforcement Act of 2015 Introduced June 17, 2015 by Susan Brooks (R-IN) this bill requires the Department of Health and Human Services (HHS)in cooperation with the Department of Veterans Affairs, the Department of Defense, and the Drug Enforcement Administration (DEA), to convene a Pain Management Best Practices Inter-Agency Task Force to develop and study best practices for pain management and prescription of pain medication. HR 4499 Introduced February 9, 2016 by Alex Mooney (R-VA) Promoting Responsible Opioid Prescribing Act of 2016. To amend title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program and for other purposes.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medical liability reform (H.R. 836/S. 884, H.R. 4771) Mental health & opioid abuse policy (H.R. 2646, H.R. 4435, S. 1893, S. 1913, S. 524, S. 2680, S. 480, S. 2687, H.R. 4843, H.R. 4499/S. 2758, H.R. 3680, H.R. 3691, H.R. 4599, H.R. 4651, H.R. 4976, H.R. 4978, H.R. 4982, H.R. 4969) 340B discount drug program Chronic care policy Nurse education policy (H.R. 977/H.R. 1784/S. 629, H.R. 2713)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health Insurance Coverage, Genetic Testing (general); Health Disparities (general); Emergency Contraception (general); Health Care Reform Implementation; Drug Dependence (general); HIV Screening (general); Gynecologic Cancer (general); Gynecologic devices (general); Breast Cancer (general); Breastfeeding (general); Medical Liability Reform (general); Health IT (general); Prematurity (general); Disparities (general); Prevention and Public Health Fund (general); Maternal Mortality and Morbidity (general); Imaging (general); Graduate Medical Education (general); Quality Improvement Measurement (general); Contraception (general); Postpartum Depression (general); CMS Provider Penalties (general); Preeclampsia (general); National Health Service Corps (general); Abortion (general); Indian Health (general); Teaching Health Centers (general); Research in Pregnant and Breastfeeding Women (general); Meaningful Use Stage 3; H.R. 3940, Meaningful Use Hardship Relief Act; H.R.4695/S. 466, Quality Care for Moms and Babies Act; H.R. 3865/S.2542, Cradle Act; H.R. 836/S. 884, Health Care Safety Net Enhancement Act; H.R. 865, Good Samaritan Health Professionals Act; H.R. 2603/S. 1475, Saving Lives, Saving Costs Act; H.R. 4774, Training Tomorrows Doctors Today Act; H.R. 3658/S. 84, GEDI Act; H.R. 4771, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016; H.R. 1209/S.628 Improving Access to Maternity Care Act; Implementation of H.R. 1462/S. 799, Protecting our Infants Act; H.R. 3691/S. 2226, Improving Treatment for Pregnant and Postpartum Women Act; H.R. 448/S.217, Women's Health Protection Act of 2015; H.R. 2972, Equal Access to Abortion Coverage in Health Insurance (EACH Woman) Act; H.Res. 461, Establishing a Select Investigative Panel of the Committee on Energy and Commerce; Fetal Tissue Research (General); H.R. 3706/S.1911, Reach Every Mother and Child Act of 2016; H.Res. 558/S.Res. 327, Condemning Violence That Targets Healthcare for Women; H.R. 4924/S.48, Prenatal Nondiscrimination Act (PRENDA) of 2016; Senate Biomedical Innovations Packages (general); S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act; S.2742, Promoting Biomedical Research and Public Health for Patients Act; H.R. 3656/S. 2100, Tobacco to 21 Act; H.R. 3652/S. 674, 21st Century Womens Health Act; S. 1532, Affordability is Access Act; H.R. 2058, FDA Deeming Authority Clarification Act of 2015; H.R. 3441, Accurate Education for Prenatal Screenings Act; H.R. 3235/S. 2311, Bringing Postpartum Depression Out of the Shadows Act; Shackling During Pregnancy (general); and H.R. 3539, Reinvigorating Antibiotic and Diagnostic Innovation Act; H.R. 5369, Healthy Start Reauthorization Act; S. 3070, Hygiene Assistance for Families of Infants and Toddlers Act of 2016; H.R. 5219 Safe Medications for Moms and Babies Act of 2016; H.R. 953/S. 524, Comprehensive Addiction and Recovery Act; H.R. 2646, Helping Families in Mental Health Crisis Act; S. 2680, Mental Health Reform Act; H.R. 3537, Synthetic Drug Control Act; H.R. 4499/S. 2758, Promoting Responsible Opioid Prescribing (PROP) Act; H.R. 4874, Prevent Abuse by Using Interstate Exchange Act; H.R. 2805/S. 1134, Heroin and Prescription Opioid Abuse, Prevention, Education, and Enforcement Act; H.R. 2654/S. 1512, Pregnant Workers Fairness Act; H.R. 1706/S.2765, Real Education for Healthy Youth Act.

Client expense: $486,704 · Firm income: Not reported

Government targets: Administration for Children & Families (ACF), Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, White House Office

Medical liability issues; continuing medical education; graduate medical education. H.R. 4499, S. 2758 PROP Act, H.R. 4365, S. 2932

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

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

Opioid Abuse; Prescription Drugs; Pharmaceutical Innovation. HR 953 Introduced February 12, 2015 by James Sensenbrenner, JR. (R-WI) To authorize the Attorney General to award grants to address the national epidemics of prescription opioid abuse and heroin use. HR 2805 Introduced July 17, 2015 by Susan Brooks (R-IN) To address prescription opioid abuse and heroin use. HR 4499 Introduced February 9, 2016 by Alex Mooney (R-VA) Promoting Responsible Opioid Prescribing Act of 2016. To amend Title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program, and for other purposes.

Client expense: Not reported · Firm income: Not reported

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

Increasing Competition in Pharmaceuticals Act (S. 2615); provisions related to hospital pharmacy operations. Promoting Responsible Opioid Prescribing Act of 2016 (H.R. 4499); all provisions generally. Issues related to prescription drug shortages and generic drug pricing.

Client expense: $190,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support S 258 and HR 169, Critical Access Hospital Relief Act, a bill that would remove the 96-hour physician certification requirement as a condition of payment for critical access hospitals (CAHs); Support HR 293, a bill to exempt certain journals and text books used in continuing medical education (CME) from manufacturer transparency reporting requirements; Participated in the Hearing, Examining the 340B Drug Pricing Program and submitted testimony about the 340B program, a federal drug discount program to Subcommittee members who will review the functionality of the program to ensure it is meeting its intended goals; HR 6, 21st Century Cures, a bill that accelerates the discovery and development of cures, and also includes provisions addressing interoperability of health IT and would provide additional money to NIH and the FDA; Two midnight discussion with several members of Congress; Support, Advancing Telehealth Opportunities in Medicare Telehealth, submitted a letter outlining the benefits of telehealth and showcases successful hospital and health system efforts. It also outlines barriers to greater use of telehealth; Submitted letter pertaining to interoperabilty within the hospital communities; Support S. 599, Improving Access to Emergency Psychiatric Care Act of 2015, legislation easing the shortage of psychiatric beds and extend and expand the CMS emergency psychiatric demonstration project; Comments on H.R.1458, BACPAC Act of 2015, a bill to amend title XVIII of the Social Security Act to provide bundled payments for post-acute care services under parts A and B of Medicare, and submitted a statement for a hearing on HR 1458 (re bundled payments for post-acute and other post-hospital services); Discussed Equity of Care Issues with Members of Congress; Advocate for funding by working with the Office of the Assistant Secretary for Preparedness and Response (ASPR) and Hospital Preparedness Program staff on ensuring adequate Ebola hospital funding; Working with the Centers for Disease Control and Prevention (CDC) on ongoing Ebola-related issues and guidance; Working with the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) to ensure that hospitals continue to be able to use blood glucose monitoring systems (BGMS) on hospitalized patients;Discussion of draft guidance on drug compounding and repackaging; Working with ASPR and CDC staff to define the impact of the Hospital Preparedness Program and Public Health Emergency Preparedness Program on improving health care system preparedness; Support efforts to advocate on Ebola within a discussion with FDA regarding impact on access to chest tubes regarding the Atrium Medical Corp and Maquet consent decree ; Advocate for regulatory approach in a discussion with White House staff regarding new initiative promoting bystander involvement in stopping hemorrhage in injured civilians; Attended a roundtable discussion on Opioid-related dependence, overdose, and death at HHS; Advocate for changes to The Care Planning Act, a bill that would provide for advanced illness care coordination services for Medicare beneficiaries; Support HR 2878 and S 1461,a bill to provide for the extension of the enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through 2015; Support S.799/HR 1462, Protecting Our Infants Act of 2015, a bill to combat the rise of prenatal opioid abuse and neonatal abstinence syndrome; Discussed S.1349, a bill that amends title XVIII (Medicare) of the Social Security Act to require a hospital or critical access hospital with an agreement with the Secretary of Health and Human Services to give each individual who receives observation services as an outpatient for more than 24 hours an adequate oral and written notification within 36 hours after beginning treatment; Supported expansions to Medicare reimbursement for telehealth along with changes to the Health Care Connect Fund; Comments on S.1648, Rural Emergency Acute Care Hospital Act of 2015, a bill to amend title XVIII of the Social Security Act to create a sustainable future for rural healthcare. Urged that HHS refrain from finalizing a stage 3 meaningful use rule; Advocate for Appropriate Surveyor Guidance on Calculated Hospitals in discussion about member concerns regarding remarks of CMS official that were confusing during a health lawyers association webinar; Discussion with CMS staff regarding proposed rule on establishing market-based payments for clinical laboratory tests; Discussion to rescind the proposed 2 percent cut to CY 2016 outpatient PPS conversion factor; Support H.R.2948, Medicare Telehealth Parity Act of 2015, a bill to amend title XVIII (Medicare) of the Social Security Act to expand telehealth coverage in three phases; Support HR 2646, Helping Families in Mental Health Crisis Act of 2015,A bill to make available needed psychiatric, psychological, and supportive services for individuals with mental illness and families in mental health crisis;Spoke with Rep. Kinds office on legislation to address the opioid epidemic in America; Support HR 1604, Veterans Mental Health Care Access Act, a bill that expands access to mental health services for veterans; Support H.R. 3183, The Veterans Health Care Freedom Act, a bill which makes significant improvements to the Veterans Choice Program; Support S 1189 The Conrad State 30 and Physician Access Act, a bill that reauthorizes the Conrad 30 and makes other changes to the program to improve patient access to care; Discussed quality measurement, meaningful use and Conditions of Participation; Conversation with CMS about the IOM Vital Signs report and how its recommendations could make quality measurement more meaningful; Spoke with CMS urging the Agency to correct the misimpression that was created statements made during a National Association of Medical Staff Specialists webinar by a CMS employee; Discussion with CMS about proposals contained in the Inpatient Psychiatric Facility PPS proposed rule urging CMS not to finalize two quality measures; Meeting at CMMI to discuss CCJR; Discuss S. 2141the Transparent Ratings on Usability and Security to Transform Information Technology Act of 2015, the TRUST Act, a bill that includes a definition of information blocking and a framework to assess interoperability of certified health IT (a health IT ratings program); Support S.1461 and H.R. 2878 a bill to provide for the extension of the enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through 2015; Oppose S. 1648 Rural Emergency Acute Care Hospital ActTo establish an alternative payment model for CAHs and small, rural hospitals whereby they may transition to become a rural emergency hospital.; Oppose H.R. 3225 Save Rural Hospitals Act, a bill to amend titles XVIII and XIX of the Social Security Act to provide for enhanced payments to rural health care providers under the Medicare and Medicaid programs; Discuss S. 1945 Mental Health Reform Act of 2015, a bill to make available needed psychiatric, psychological, and supportive services for individuals with mental illness and families in mental health crisis. It would reauthorize certain federal mental health programs, revise the IMD exclusion, reform SAMHSA, and study parity in mental health laws. Support S. 1893, The Mental Health Awareness and Improvement Act of 2015, a bill to reauthorize and improve programs related to mental health and substance use disorders; Letter asking for modifications to H.R. 3298 Medicare Post-Acute Care Value-Based Purchasing (PAC VBP) Act of 2015, the legislation would establish a value-based purchasing program for LTCHs, IRFs, SNFs and HH agencies. Worked to streamline and improve quality measures; Discussed how to implement the framework in the National Academy of Medicines Vital Signs report to streamline and focus quality measures used in Medicare programs; Discussed Opioid prescribing guidelines with the CDC to provide feedback on the opioid prescribing guidelines they were developing; Discussion with CMS regarding CAH designation status, negative impact of Insurance Consolidations on Medicare Advantage and for modifications to Comprehensive Care for Joint Replacement (CJR) model regarding aspects of the proposed rule; Discussion with CMS about the Emergency Preparedness final rule; Discussion with CMS regarding the 0.2 percent reduction to hospitals payments under the Inpatient Prospective Payment System (PPS); Support S. 524, the Johnson amendment and the Collins amendment, Comprehensive Addiction and Recovery Act of 2016, a bill to authorize the Attorney General to award grants to address the national epidemics of prescription opioid abuse and heroin use; Support H.R. 4499, Promoting Responsible Opioid Prescribing Act of 2016, a bill to amend title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program; Support S. 2220, The Healthy Maternity and Obstetric Medicine Act or Healthy MOM Act guarantees maternity coverage for women who are enrolled in the exchanges established under the Affordable Care Act, as well as women who are covered by individual and group insurance plans and federal employee health benefit plans; Comments to House Ways and Means and Senate Finance Committees on how to improve the physician self-referral (Stark) law; Urged CMS to delay the April 2016 release of the hospital star ratings on the Hospital Compare Website; Supported House and Senate letters urging CMS to delay release of hospital star ratings on the Hospital Compare Website; Support H.R. 4771, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act, a bill that would reduce health care costs and promote access to quality, affordable health care for all Americans; Comments on Senate HELP Committee draft legislation addressing health information technology (IT) and electronic health records (EHRs); Comments to CMS regarding addressing section 603 of the BBA of 2015 in regulation; Comments to House Energy & Commerce Committee regarding section 603 of the BBA of 2015 as well as site neutral payment policies in general; Statement for the record to House Energy & Commerce Committee on MACRA implementation; Comments to the Senate Finance Committee Chronic Care document -Conversations with the CDC related to their opioid guidelines for chronic pain as well as a patient education piece about opioids; Discussions with CMS about CAH designation status Health Care Issues; Discussions with Rep. Hudson about H.R. 4365, the Protecting Patient Access to Emergency Medications Act , a bill to amend the Controlled Substances Act with regard to the provision of emergency medical services; Support H.R. 4650 and S. 2108, Preserving Patient Access to Post-Acute Hospital Care Act of 2016, a bill to amend title XVIII of the Social Security Act to provide for an extension of certain Medicare long-term care hospital payment rules; Supported efforts to encourage Congress to send CMS letters on addressing the issue of colocation of facilities within a hospital; Discussions with Members of Congress on the potential implementation of Unique Device Identification on claims forms; Sponsored a Hill briefing on innovations in post-acute care.

Client expense: $5,120,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Communications Commission (FCC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office

H.R. 2102, Medicare Diabetes Prevention Act of 2015, all provisions S. 1131, Medicare Diabetes Prevention Act of 2015, all provisions H.R. 4442, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act, all provisions S. 2484, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act, all provisions H.R. 4499, Promoting Responsible Opioid Prescribing (PROP) Act of 2016, all provisions H.R. 2568, Fair Medical Audits Act of 2015, all provisions S. 1913, Stopping Medication Abuse and Protecting Seniors Act of 2015, all provisions H.R. 2, Medicare Access and CHIP Reauthorization Act of 2015, provisions relating to payment and delivery reform H.R. 1470, SGR Repeal and Medicare Provider Payment Modernization Act of 2015, all provisions H.R. 6, 21st Century Cures Act, provisions relating to Sunshine/transparency 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, all provisions H.R. 1190, Protecting Seniors' Access to Medicare Act of 2015, all provisions S. 2680, Mental Health Reform Act of 2016, all provisions H.R. 2646, Helping Families in Mental Health Crisis Act of 2015, all provisions S. 2511, Improving Health Information Technology Act, all provisions S. 2141, TRUST IT Act, all provisions S. 810, SGR Repeal and Medicare Provider Payment Modernization Act of 2015, all provisions H.R. 4227, Medicare Advantage Bill of Rights Act of 2015, all provisions S. 2392, Medicare Advantage Bill of Rights Act of 2015, all provisions Medicare program: Meaningful Use Regulations/Electronic Health Records (EHRs) Medicare program: EHR interoperability and certification Medicare program: Electronic prior-authorization Medicare program: Independent Payment Advisory Board (IPAB) Repeal Medicare program: Graduate Medical Education Medicare program: Telemedicine Medicare program: Telehealth and remote patient monitoring services Medicare program: Chronic Care Medicare program: Diabetes Prevention Medicare program: Comprehensive care for joint replacement Medicare program: Medicare Part B Drug Pricing/Reimbursement Medicare program: Medicare Part B Drug Demonstration program Medicare program: Transitional care management Medicare program: Medicare Access and CHIP Reauthorization Act (MACRA) implementation Medicare program: Physician Quality Reporting System (PQRS) Medicare program: Merit-Based Incentive Payment System (MIPS) Medicare program: Value-Based Modifier (VBM) Medicare program: Quality Reporting Medicare program: Prescription drug diversion and abuse Medicare program: Physician data Medicare program: Unique Device Identifier inclusion on claim forms Medicare program: ACO Improvement Act Medicare program: Health data security Medicare program: Protecting Access to Medicare Act (PAMA) implementation Medicare program: Provider network adequacy and balance billing Medicare program: Sunshine/Open Payments Medicare program: Resource use Medicare program: Health Insurance Portability and Accountability Act (HIPAA) Medicare program: PECOS/Medicare enrollment Medicare and Medicaid programs: Alternative payment models Medicare and Medicaid programs: Home Blood Pressure Monitoring equipment Medicare and Medicaid programs: ICD-10 Medicare and Medicaid programs: Procedure coding Medicare and Medicaid programs: Behavioral health management

Client expense: $6,600,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Science & Technology Policy (OSTP), SENATE, Veterans Affairs, Dept of (VA), White House Office

Opioid Abuse; Prescription Drugs; Pharmaceutical Innovation HR 953 Introduced February 12, 2015 by James Sensenbrenner, Jr. (R-WI) To authorize the Attorney General to award grants to address the national epidemics of prescription opioid abuse and heroin use. HR 2805 Introduced July 17, 2015 by Susan Brooks (R-IN) To address prescription opioid abuse and heroin use. HR 4499 Introduced February 9, 2016 by Alex Mooney (R-VA) Promoting Responsible Opioid Prescribing Act of 2016. To amend title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program, and for other purposes.

Client expense: $1,940,000 · Firm income: Not reported

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

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: $661,366 · 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.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.3081-TELEmedicine for MEDicare (TELE-MED) Act of 2015 H.R.3250-DXM Abuse Prevention Act of 2015 H.R.3379-Airplane Kids In Transit Safety (KITS) 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.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 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.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.2680-Mental Health Reform Act of 2016 S.2687-Plan of Safe Care Improvement Act

Client expense: $661,366 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE