Expanding Oversight of Opioid Prescribing and Payment Act of 2018

S. 2460, Every Prescription Conveyed Securely Act (Bennet) - opioid issues S. 2680, Opioid Crisis Response Act (Alexander) - opioid initiatives, mental health parity S. 2789, Substance Abuse Prevention Act (Cornyn) - opioid initiatives, restrictions on step therapy S. 2812, Air Ambulance Consumer Protection Act (McCaskill) - air ambulance S. 2828, Sober Home Fraud Detection Act (Rubio) - best practices for identifying fraud in recovery housing S. 2891, Fighting the Opioid Epidemic with Sunshine Act (Grassley) - opioid issues S. 2892, Peer Support Enhancement and Evaluation Review Act (Cardin) - opioid issues S. 2898, Medication-Assisted Treatment Improvement Act (Casey) - opioid issues S. 2899, Caring Recovery for Infants and Babies Act (Brown) - opioid issues S. 2900, Comprehensive Screenings for Seniors Act (Brown) - opioid issues S. 2902, Better Data Sharing to Combat the Opioid Crisis Act (Cassidy) - opioid issues S. 2905, Strengthening Partnerships to Prevent Opioid Abuse Act (Toomey) - opioid issues S. 2910, Telehealth for Childrens Access to Services and Treatment Act (Roberts) - opioid issues S. 2911, Enhancing Patient Access to Non-Opioid Treatment Options (Heller) - opioid issues S. 2912, Opioid Addiction Treatment Programs Enhancement Act (Cassidy) - opioid issues S. 2920, Commit to Opioid Medical Prescriber Accountability and Safety for Seniors Act (McCaskill) - opioid issues S. 2922, Help for Moms and Babies Act (Stabenow) - opioid issues S. 2923, Building Capacity for Family-Focused Residential Treatment Act (Grassley) - opioid issues S. 2924, Supporting Family-Focused Residential Treatment Act (Scott) - opioid issues S. 3016, Action for Dental Health Act (Booker) - grants for oral health programs S. 3120, the HEAL Substance Use Disorders Act (Hatch) - opioid initiatives S. 3158, Labor-HHS-Education Appropriations Act (Blunt) - HHS funding S. 3254, Eliminating Kickbacks in Recovery Act (Rubio) - anti-kickback penalties for body brokers Draft Bill: Protecting Patients From Surprise Medical Bills Act (Cassidy) - surprise medical bills H.R. 6, SUPPORT Patients and Families Act (Walden) - opioid initiatives, Medicare and Medicaid issues, budget offsets H.R. 302, FAA Reauthorization Act - air ambulance issues H.R. 1215, Protecting Access to Care Act (King) - medical liability reform H.R. 1313, Preserving Employee Wellness Programs Act (Foxx) - employee wellness programs H.R. 2422, Action for Dental Health Act (Kelly) - oral health services and education for underserved populations H.R. 3331, adoption and use of EHR technology by behavioral health providers (Jenkins) - opioid issues H.R. 3528, Every Prescription Conveyed Securely Act (Clark) - opioid issues H.R. 4684, Ensuring Access to Quality Sober Living Act (Chu) - best practices for recovery housing H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act (Schweikert) - opioid issues H.R. 4998, Health Insurance for Former Foster Youth Act (Bass) - opioid issues H.R. 5100, Recovery Home Certification Act (Knight) -- anti-kickback penalties for body brokers H.R. 5477, Rural DOCS Act (O'Halleran) - opioid issues H.R. 5515, National Defense Authorization Act (Thornberry) H.R. 5562, Protecting NAS Babies Act (Jenkins) - opioid issues H.R. 5582, Abuse Deterrent Access Act (Carter) - opioid issues H.R. 5583, State reporting on certain adult health quality measures (Clarke) - opioid issues H.R. 5590, CMS Action Plan (Kinzinger) - opioid issues H.R. 5714, Education for Disposal of Unused Opioids Act (Black) - opioid issues H.R. 5715, Strengthening Partnerships to Prevent Opioid Abuse Act (Renacci) - opioid issues H.R. 5716, COMPASS Act (Roskam) - opioid issues H.R. 5723, Expanding Oversight of Opioid Prescribing and Payment Act (Tenney) - opioid issues H.R. 5725, BEST Act (Roskam) - opioid issues H.R. 5774, Combating Opioid Abuse for Care in Hospitals Act (Curbelo) - opioid issues H.R. 5775, Providing Reliable Options for Patients and Educational Resources Act (Paulsen) - opioid issues H.R. 5776, MOST Act (Neal) - opioid issues H.R. 5789, protections for pregnant and post-partum women (Foster) - opioid issues H.R. 5795, Overdose Prevention and Patient Safety Act (Blumenauer) - confidential sharing of substance use disorder information H.R. 5796, Responsible Education Achieves Care and Healthy Outcomes for Users' Treatment Act (Fitzpatrick) - opioid issues H.R. 5801, PARTNERSHIP Act (Griffith) - opioid issues H.R. 6082, Overdose Prevention and Patient Safety Act (Mullin) - confidential sharing of substance use disorder information H.R. 6147, Interior, Environment, Financial Services, Agriculture, FDA, Transportation, and Housing Appropriations Act (Calvert) - FDA funding H.R. 6157, Defense-Labor-HHS-Education Appropriations Act (Granger) - HHS funding H.R. 6753, Strengthening the Health Care Fraud Prevention Task Force Act (Walden) - codification of Healthcare Fraud Prevention Partnership H.R. 6878, Eliminating Kickbacks in Recovery Act (Deutch) - anti-kickback penalties for body brokers H.R. 6902, Eliminating Kickbacks in Recovery Act (Knight) - anti-kickback penalties for body brokers Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10), identifiers including the health plan identifier, enforcement; cybersecurity; FEHBP enrollment data clearinghouse initiative, the enrollment reconciliation process, and a related OPM reimbursement factor for records that cannot be reconciled; issues relating to health insurance plan participation in FEHBP, including contract requirements; issues relating to similarly sized subscriber group (SSSG) and MLR requirements under the FEHBP; implementation of the health savings account provisions of the Medicare Act; issues related to Medicare Secondary Payer requirements; issues related to implementation of the National Health Information Infrastructure; electronic health records, personal health records, and similar technologies; issues relating to market consolidation; issues related to hospital consolidation; issues relating to quality improvement; issues relating to the national health data stewardship; issues relating to hospital outpatient measurement and reporting; prescription drug pricing; issues related to the collection of race and ethnicity data; issues related to medical loss ratios; reference pricing; review of rates for reasonableness; preexisting condition insurance plans; issues relating to antitrust; accountable care organizations; provider non-discrimination; coverage of preventive services; contraceptive coverage; pre-existing condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; issues relating to the annual fee on health insurance providers; health plan automatic enrollment requirements; issues related to qualified health plans including certification and rate filing templates; health insurance market rules; reinsurance, risk corridors, and risk adjustment; dependent coverage; summary of benefits and coverage disclosures; benefit and payment parameters; essential health benefits, actuarial value, and accreditation; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations; issues related to supplemental products; issues related to HIPAA excepted benefits; issues related to short term limited duration products; issues related to the federally-facilitated marketplaces (i.e., Exchanges/formerly referred to as the web portal); issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); issues related to association health plans; issues related to cost-sharing reductions (CSRs); issues related to the refundable credit for coverage under a qualified health plan; issues related to small employer group size; issues related to Certificate of Public Advantage; issues relating to veterans health care; issues relating to family caregivers; and other issues relating to health care reform implementation.

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

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

S. 1625, FY 2018 Consolidated Appropriations Act (Royce) - funding for HHS programs and agencies, opioid initiatives, ACA risk corridors S. 2460, Every Prescription Conveyed Securely Act (Bennet) - opioid issues S. 2680, Opioid Crisis Response Act (Alexander) - opioid initiatives, mental health parity S. 2789, Substance Abuse Prevention Act (Cornyn) - opioid initiatives, restrictions on step therapy S. 2812, Air Ambulance Consumer Protection Act (McCaskill) - air ambulance S. 2891, Fighting the Opioid Epidemic with Sunshine Act (Grassley) - opioid issues S. 2892, Peer Support Enhancement and Evaluation Review Act (Cardin) - opioid issues S. 2898, Medication-Assisted Treatment Improvement Act (Casey) - opioid issues S. 2899, Caring Recovery for Infants and Babies Act (Brown) - opioid issues S. 2900, Comprehensive Screenings for Seniors Act (Brown) - opioid issues S. 2902, Better Data Sharing to Combat the Opioid Crisis Act (Cassidy) - opioid issues S. 2905, Strengthening Partnerships to Prevent Opioid Abuse Act (Toomey) - opioid issues S. 2910, Telehealth for Childrens Access to Services and Treatment Act (Roberts) - opioid issues S. 2911, Enhancing Patient Access to Non-Opioid Treatment Options (Heller) - opioid issues S. 2912, Opioid Addiction Treatment Programs Enhancement Act (Cassidy) - opioid issues S. 2920, Commit to Opioid Medical Prescriber Accountability and Safety for Seniors Act (McCaskill) - opioid issues S. 2922, Help for Moms and Babies Act (Stabenow) - opioid issues S. 2923, Building Capacity for Family-Focused Residential Treatment Act (Grassley) - opioid issues S. 2924, Supporting Family-Focused Residential Treatment Act (Scott) - opioid issues S. 2987, National Defense Authorization Act (Inhofe) S. 3120, the HEAL Substance Use Disorders Act (Hatch) - opioid initiatives S. 3158, FY 2019 Labor, HHS, Education Appropriations Act (Blunt) - HHS funding, ACA issues House version of FY 2019 Labor, HHS, Education Appropriations Act (Cole) - HHS funding, ACA issues H.R. 6, SUPPORT Patients and Families Act (Walden) - opioid initiatives, budget offsets H.R. 1215, Protecting Access to Care Act (King) - medical liability reform H.R. 1313, Preserving Employee Wellness Programs Act (Foxx) - employee wellness programs H.R. 2422, Action for Dental Health Act (Kelly) - oral health services and education for underserved populations H.R. 3331, adoption and use of EHR technology by behavioral health providers (Jenkins) - opioid issues H.R. 3528, Every Prescription Conveyed Securely Act (Clark) - opioid issues H.R. 3759, RAISE Family Caregivers Act (Harper-Castor) - support for family caregivers H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act (Schweikert) - opioid issues H.R. 4998, Health Insurance for Former Foster Youth Act (Bass) - opioid issues H.R. 5477, Rural DOCS Act (O'Halleran) - opioid issues H.R. 5562, Protecting NAS Babies Act (Jenkins) - opioid issues H.R. 5582, Abuse Deterrent Access Act (Carter) - opioid issues H.R. 5583, State reporting on certain adult health quality measures (Clarke) - opioid issues H.R. 5590, CMS Action Plan (Kinzinger) - opioid issues H.R. 5515, National Defense Authorization Act (Thornberry) H.R. 5714, Education for Disposal of Unused Opioids Act (Black) - opioid issues H.R. 5715, Strengthening Partnerships to Prevent Opioid Abuse Act (Renacci) - opioid issues H.R. 5716, COMPASS Act (Roskam) - opioid issues H.R. 5723, Expanding Oversight of Opioid Prescribing and Payment Act (Tenney) - opioid issues H.R. 5725, BEST Act (Roskam) - opioid issues H.R. 5774, Combating Opioid Abuse for Care in Hospitals Act (Curbelo) - opioid issues H.R. 5775, Providing Reliable Options for Patients and Educational Resources Act (Paulsen) - opioid issues H.R. 5776, MOST Act (Neal) - opioid issues H.R. 5789, protections for pregnant and post-partum women (Foster) - opioid issues H.R. 5795, Overdose Prevention and Patient Safety Act (Blumenauer) - confidential sharing of substance use disorder information H.R. 5796, Responsible Education Achieves Care and Healthy Outcomes for Users' Treatment Act (Fitzpatrick) - opioid issues H.R. 5801, PARTNERSHIP Act (Griffith) - opioid issues H.R. 6082, Overdose Prevention and Patient Safety Act (Mullin) - confidential sharing of substance use disorder information Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10), identifiers including the health plan identifier, enforcement; cybersecurity; FEHBP enrollment data clearinghouse initiative, the enrollment reconciliation process, and a related OPM reimbursement factor for records that cannot be reconciled; issues relating to health insurance plan participation in FEHBP, including contract requirements; issues relating to similarly sized subscriber group (SSSG) and MLR requirements under the FEHBP; implementation of the health savings account provisions of the Medicare Act; issues related to Medicare Secondary Payer requirements; issues related to implementation of the National Health Information Infrastructure; electronic health records, personal health records, and similar technologies; issues relating to market consolidation; issues related to hospital consolidation; issues relating to quality improvement; issues relating to the national health data stewardship; issues relating to hospital outpatient measurement and reporting; prescription drug pricing; issues related to the collection of race and ethnicity data; issues related to medical loss ratios; reference pricing; review of rates for reasonableness; preexisting condition insurance plans; issues relating to antitrust; accountable care organizations; provider non-discrimination; coverage of preventive services; contraceptive coverage; pre-existing condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; issues relating to the annual fee on health insurance providers; health plan automatic enrollment requirements; issues related to qualified health plans including certification and rate filing templates; health insurance market rules; reinsurance, risk corridors, and risk adjustment; dependent coverage; summary of benefits and coverage disclosures; benefit and payment parameters; essential health benefits, actuarial value, and accreditation; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations; issues related to supplemental products; issues related to HIPAA excepted benefits; issues related to short term limited duration products; issues related to the federally-facilitated marketplaces (i.e., Exchanges/formerly referred to as the web portal); issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); issues related to association health plans; issues related to cost-sharing reductions (CSRs); issues related to the refundable credit for coverage under a qualified health plan; issues related to small employer group size; issues related to Certificate of Public Advantage; issues relating to veterans health care; issues relating to family caregivers; and other issues relating to health care reform implementation.

H.R. 714 Use of Medicinal Marihuana H.R. 715 Rescheduling of Marihuana H.R. 975 Controlled Substances Act Application to Marihuana H.R. 1781 Synthetic Opioids H.R. 1824 Federal and State Marijuana Policy Gap Reduction S. 581 Opioids Addiction Information in Medical Records S. 780 Federal and State Marijuana Policy Gap Reduction H.R. 2020 Rescheduling of Marijuana H.R. 2063 Opioid Dispensary Registration Training Condition S. 1078 FDA Opioid Approval Procedures S. 1079 FDA Opioid Approval and Revocation S. 1327 Controlled Substance Analogues Regulation H.R. 3374 Drunk Driving H.R. 3534 State Legalized Marijuana S. 1553 Schedule 1 Controlled Substances S. 1554 Controlled Substance Continuing Education S. 1689 Controlled Substances Act H.R. 3964 Registration Requirements for Prescribers of Opioids H.R. 4482 Opioid Abuse and Addiction S. 2008 Opioid Epidemic and Drug Sample Backlogs H.R. 4903 Opioid Usage Reduction Best Practices Study H.R. 4922 Fentanyl Analogues H.R. 5109 Opioid Epidemic Distribution of Resources S. 2437 Opioid Grant Program S. 2440 Opioid Epidemic S. 2535 Opioid Quotas H.R. 5473 Alternative Methods for Data Collection H.R. 5581 Prescribers of Controlled Substances H.R. 5590 Medicare and Opioid Addictions H.R. 5723 Medicare Payment Advisory Commission H.R. 5782 Pharmaceutical Company Accountability S. 2680 Opioid Crisis S. 2691 Pharmaceutical Companies and Illegal Marketing S. 2729 Prevention of Prescription Opioid Misuse S. 2838 Reporting Information on Distribution of Opioids S. 2848 Controlled Substances and Alcohol Testing H.R. 6491 Reporting of Information on Distribution of Opioids H.R. 6608 Prescription Drug Monitoring Programs Data Collection H.R. 5812 Controlled Substance Overdose Prevention Activities

H.R.5723 - Expanding Oversight of Opioid Prescribing and Payment Act of 2018 H.R.5739 - Prescription Drug and Medical Device Price Review Board Act of 2018 S.2981 - Opioid Overdose Reduction Act of 2018 H.R.6143 - Patient Right to Know Drug Prices Act H.R.6133 - Informing Opioid Prescribing Through Evidence-Based Guidelines Act of 2018 S. 2554 - Patient Right to Know Drug Prices Act S. 2553 - Know the Lowest Price Act of 2018

Client expense: $330,000 · Firm income: Not reported

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

H.R. 714 Use of Medicinal Marihuana H.R. 715 Rescheduling of Marihuana H.R. 975 Controlled Substances Act Application to Marihuana H.R. 1781 Synthetic Opioids H.R. 1824 Federal and State Marijuana Policy Gap Reduction S. 581 Opioids Addiction Information in Medical Records S. 780 Federal and State Marijuana Policy Gap Reduction H.R. 2020 Rescheduling of Marijuana H.R. 2063 Opioid Dispensary Registration Training Condition S. 1078 FDA Opioid Approval Procedures S. 1079 FDA Opioid Approval and Revocation S. 1327 Controlled Substance Analogues Regulation H.R. 3374 Drunk Driving H.R. 3534 State Legalized Marijuana S. 1553 Schedule 1 Controlled Substances S. 1554 Controlled Substance Continuing Education S. 1689 Controlled Substances Act H.R. 3964 Registration Requirements for Prescribers of Opioids H.R. 4482 Opioid Abuse and Addiction S. 2008 Opioid Epidemic and Drug Sample Backlogs H.R. 4903 Opioid Usage Reduction Best Practices Study H.R. 4922 Fentanyl Analogues H.R. 5109 Opioid Epidemic Distribution of Resources S. 2437 Opioid Grant Program S. 2440 Opioid Epidemic S. 2535 Opioid Quotas **Issues lobbied without specific bill number: Workers' Compensation Medicare Set-Aside H.R. 5473 Alternative Methods for Data Collection H.R. 5581 Prescribers of Controlled Substances H.R. 5590 Medicare and Opioid Addictions H.R. 5723 Medicare Payment Advisory Commission H.R. 5782 Pharmaceutical Company Accountability S. 2680 Opioid Crisis S. 2691 Pharmaceutical Companies and Illegal Marketing S. 2729 Prevention of Prescription Opioid Misuse S. 2838 Reporting Information on Distribution of Opioids S. 2848 Controlled Substances and Alcohol Testing

Client expense: $1,590,000 · Firm income: Not reported

H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to controlled substances H.R. 3528: Every Prescription Conveyed Securely Act - e-Prescribing for coverage under part D of the Medicare program of prescription drugs that are controlled substances H.R. 3545: Overdose Prevention and Patient Safety Act - Provisions related to substance use disorder information sharing H.R. 3692: Addiction Treatment Access Improvement Act of 2017 - Provisions related to medication assisted treatment (MAT) access H.R. 4275: Empowering Pharmacists in the Fight Against Opioid Abuse Act - Provisions related to pharmacist education H.R. 4284: Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2017 - Provisions related to substance data collection H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements H.R. 5002: Advancing Cutting Edge Research Act - Provisions related to non-addiction pain medication H.R. 5009: Jessies Law - Provisions related to patient information sharing H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5102: Substance Use Disorder Workforce Loan Repayment Act of 2018 - Provisions related to student loan repayment to substance use disorder (SUD) providers H.R. 5150: Protecting Medicare from Excessive Price Increases Act of 2018 - To require drug manufacturers to pay a Medicare part B rebate for certain drugs H.R. 5151: To amend the Public Health Service Act to reauthorize a grant program improving treatment for pregnant and postpartum women H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5247: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 5261: Treatment, Education, and Community Help to Combat Addiction Act of 2018 - Provisions related to grants for substance use disorder (SUD) prevention, treatment, and recovery H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5327: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to opioid recovery center grants H.R. 5329: Poison Center Network Enhancement Act of 2018 - Provisions related to national poison center funding and other prevention funding H.R. 5353: Eliminating Opioid Related Infectious Diseases Act of 2018 - Provisions related to CDC infection surveillance and other funding H.R. 5477: Rural DOCS Act - To provide for a demonstration project to increase substance use provider capacity under the Medicaid program H.R. 5580: STOP Fentanyl Deaths Act of 2018 - To authorize the Secretary of Health and Human Services to conduct programs to address the usage of illicit drugs, particularly fentanyl H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 5676: Stop Excessive Narcotics in our Retirement Communities Protection Act of 2018 - To authorize the suspension of payments by Medicare prescription drug plans and MA-PD plans pending investigations of credible allegations of fraud by pharmacies H.R. 5687: SOUND Disposal and Packaging Act - Provisions related to packaging and disposal methods with respect to certain drugs H.R. 5711: Improving Access to Mental Health Services Act - To allow National Health Service Corps members to provide obligated service as behavioral and mental health professionals at schools, other community-based settings, or patient homes H.R. 5723: Expanding Oversight of Opioid Prescribing and Payment Act of 2018 - To require the Medicare Payment Advisory Commission to report on opioid payment, adverse incentives, and data under the Medicare program H.R. 5752: Stop Illicit Importation Act of 2018 - Provisions related to importation H.R. 5762: Joint Task Force to Combat Opioid Trafficking Act of 2018 - To authorize a Joint Task Force to enhance integration of the Department of Homeland Securitys border security operations to detect, interdict, disrupt, and prevent narcotics, such as fentanyl and other synthetic opioids, from entering the United States H.R. 5774: Combating Opioid Abuse for Care in Hospitals Act of 2018 - Provisions related to opioids H.R. 5775: Providing Reliable Options for Patients and Educational Resources Act of 2018 - To require Medicare Advantage plans and part D prescription drug plans to include information on the risks associated with opioids, coverage of certain nonopioid treatments used to treat pain, and on the safe disposal of prescription drugs H.R. 5796: Responsible Education Achieves Care and Healthy Outcomes for Users' Treatment (REACH OUT) Act of 2018 - To require the Secretary of Health and Human Services to provide grants for eligible entities to provide technical assistance to outlier prescribers of opioids H.R. 5803: SAFETY Act of 2018 - Provisions related to drug approval H.R. 5811: Long-Term Opioid Efficacy Act of 2018 - Postapproval study requirements H.R. 6071: SERV Communities Act - Provisions related to transparency in the 340B program H.R. 6110: Dr. Todd Graham Pain Management, Treatment, and Recovery Act of 2018' H.R. 6142: Reducing Drug Waste Act of 2018 - Action plan and report on vial size waste S. 204: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 1327: SITSA Act - Provisions related to controlled substances S. 2312: HELP Act - Provisions related to 340B program S. 2406: ACE Research Act - Research initiatives of the NIH S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - Provisions related to drug pricing S. 2589: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to CDC infection surveillance and other funding S. 2665: A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety S. 2680: Opioid Crisis Response Act of 2018 - Provisions related to opioids S. 2842: Opioid Addiction Recovery Fraud Prevention Act of 2018 - Provisions related to opioid treatment programs or products S. __: Drug Accepted Use Labeling Act of 2018 - Provisions related to labeling Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development of FDA policy Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Opioids shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

H.R.5723 - Expanding Oversight of Opioid Prescribing and Payment Act of 2018 H.R.5739 - Prescription Drug and Medical Device Price Review Board Act of 2018 S.2981 - Opioid Overdose Reduction Act of 2018 H.R.6143 - Patient Right to Know Drug Prices Act H.R.6133 - Informing Opioid Prescribing Through Evidence-Based Guidelines Act of 2018

Client expense: $330,000 · Firm income: Not reported

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

S. 1625, FY 2018 Consolidated Appropriations Act (Royce) - funding for HHS programs and agencies, opioid initiatives, ACA risk corridors S. 2460, Every Prescription Conveyed Securely Act (Bennet) - opioid issues S. 2680, Opioid Crisis Response Act (Alexander) - opioid initiatives, mental health parity S. 2789, Substance Abuse Prevention Act (Cornyn) - opioid initiatives, restrictions on step therapy S. 2812, Air Ambulance Consumer Protection Act (McCaskill) - air ambulance S. 2891, Fighting the Opioid Epidemic with Sunshine Act (Grassley) - opioid issues S. 2892, Peer Support Enhancement and Evaluation Review Act (Cardin) - opioid issues S. 2898, Medication-Assisted Treatment Improvement Act (Casey) - opioid issues S. 2899, Caring Recovery for Infants and Babies Act (Brown) - opioid issues S. 2900, Comprehensive Screenings for Seniors Act (Brown) - opioid issues S. 2902, Better Data Sharing to Combat the Opioid Crisis Act (Cassidy) - opioid issues S. 2905, Strengthening Partnerships to Prevent Opioid Abuse Act (Toomey) - opioid issues S. 2910, Telehealth for Childrens Access to Services and Treatment Act (Roberts) - opioid issues S. 2911, Enhancing Patient Access to Non-Opioid Treatment Options (Heller) - opioid issues S. 2912, Opioid Addiction Treatment Programs Enhancement Act (Cassidy) - opioid issues S. 2920, Commit to Opioid Medical Prescriber Accountability and Safety for Seniors Act (McCaskill) - opioid issues S. 2922, Help for Moms and Babies Act (Stabenow) - opioid issues S. 2923, Building Capacity for Family-Focused Residential Treatment Act (Grassley) - opioid issues S. 2924, Supporting Family-Focused Residential Treatment Act (Scott) - opioid issues S. 2987, National Defense Authorization Act (Inhofe) S. 3120, the HEAL Substance Use Disorders Act (Hatch) - opioid initiatives S. 3158, FY 2019 Labor, HHS, Education Appropriations Act (Blunt) - HHS funding, ACA issues House version of FY 2019 Labor, HHS, Education Appropriations Act (Cole) - HHS funding, ACA issues H.R. 6, SUPPORT Patients and Families Act (Walden) - opioid initiatives, budget offsets H.R. 1215, Protecting Access to Care Act (King) - medical liability reform H.R. 1313, Preserving Employee Wellness Programs Act (Foxx) - employee wellness programs H.R. 2422, Action for Dental Health Act (Kelly) - oral health services and education for underserved populations H.R. 3331, adoption and use of EHR technology by behavioral health providers (Jenkins) - opioid issues H.R. 3528, Every Prescription Conveyed Securely Act (Clark) - opioid issues H.R. 3759, RAISE Family Caregivers Act (Harper-Castor) - support for family caregivers H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act (Schweikert) - opioid issues H.R. 4998, Health Insurance for Former Foster Youth Act (Bass) - opioid issues H.R. 5477, Rural DOCS Act (O'Halleran) - opioid issues H.R. 5562, Protecting NAS Babies Act (Jenkins) - opioid issues H.R. 5582, Abuse Deterrent Access Act (Carter) - opioid issues H.R. 5583, State reporting on certain adult health quality measures (Clarke) - opioid issues H.R. 5590, CMS Action Plan (Kinzinger) - opioid issues H.R. 5515, National Defense Authorization Act (Thornberry) H.R. 5714, Education for Disposal of Unused Opioids Act (Black) - opioid issues H.R. 5715, Strengthening Partnerships to Prevent Opioid Abuse Act (Renacci) - opioid issues H.R. 5716, COMPASS Act (Roskam) - opioid issues H.R. 5723, Expanding Oversight of Opioid Prescribing and Payment Act (Tenney) - opioid issues H.R. 5725, BEST Act (Roskam) - opioid issues H.R. 5774, Combating Opioid Abuse for Care in Hospitals Act (Curbelo) - opioid issues H.R. 5775, Providing Reliable Options for Patients and Educational Resources Act (Paulsen) - opioid issues H.R. 5776, MOST Act (Neal) - opioid issues H.R. 5789, protections for pregnant and post-partum women (Foster) - opioid issues H.R. 5795, Overdose Prevention and Patient Safety Act (Blumenauer) - confidential sharing of substance use disorder information H.R. 5796, Responsible Education Achieves Care and Healthy Outcomes for Users' Treatment Act (Fitzpatrick) - opioid issues H.R. 5801, PARTNERSHIP Act (Griffith) - opioid issues H.R. 6082, Overdose Prevention and Patient Safety Act (Mullin) - confidential sharing of substance use disorder information Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10), identifiers including the health plan identifier, enforcement; cybersecurity; FEHBP enrollment data clearinghouse initiative, the enrollment reconciliation process, and a related OPM reimbursement factor for records that cannot be reconciled; issues relating to health insurance plan participation in FEHBP, including contract requirements; issues relating to similarly sized subscriber group (SSSG) and MLR requirements under the FEHBP; implementation of the health savings account provisions of the Medicare Act; issues related to Medicare Secondary Payer requirements; issues related to implementation of the National Health Information Infrastructure; electronic health records, personal health records, and similar technologies; issues relating to market consolidation; issues related to hospital consolidation; issues relating to quality improvement; issues relating to the national health data stewardship; issues relating to hospital outpatient measurement and reporting; prescription drug pricing; issues related to the collection of race and ethnicity data; issues related to medical loss ratios; reference pricing; review of rates for reasonableness; preexisting condition insurance plans; issues relating to antitrust; accountable care organizations; provider non-discrimination; coverage of preventive services; contraceptive coverage; pre-existing condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; issues relating to the annual fee on health insurance providers; health plan automatic enrollment requirements; issues related to qualified health plans including certification and rate filing templates; health insurance market rules; reinsurance, risk corridors, and risk adjustment; dependent coverage; summary of benefits and coverage disclosures; benefit and payment parameters; essential health benefits, actuarial value, and accreditation; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations; issues related to supplemental products; issues related to HIPAA excepted benefits; issues related to short term limited duration products; issues related to the federally-facilitated marketplaces (i.e., Exchanges/formerly referred to as the web portal); issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); issues related to association health plans; issues related to cost-sharing reductions (CSRs); issues related to the refundable credit for coverage under a qualified health plan; issues related to small employer group size; issues related to Certificate of Public Advantage; issues relating to veterans health care; issues relating to family caregivers; and other issues relating to health care reform implementation.

Provider Enrollment; Medicare and Medicaid; Medicare-Medicaid for Primary Care; Reimbursement including Out-of-Network Payments/Out-of-NetworkReimbursement; insurance transparency prudent lay person standard; ACA (coverage of essential health benefits); H.R.2; H.R.4015; S.2694; H.R.5723;S.3040; HR 1625; Repeal & Replace of ACA; insurance market stabilization.

Client expense: Not reported · Firm income: Not reported

Provider Enrollment; Medicare and Medicaid; Medicare-Medicaid for Primary Care; Reimbursement including Out-of-Network Payments/Out-of-NetworkReimbursement; insurance transparency prudent lay person standard; ACA (coverage of essential health benefits); H.R.2; H.R.4015; S.2694; H.R.5723;S.3040; HR 1625; Repeal & Replace of ACA; insurance market stabilization.

Client expense: Not reported · Firm income: Not reported

Provider Enrollment; Medicare and Medicaid; Medicare-Medicaid for Primary Care; Reimbursement including Out-of-Network Payments/Out-of-Network Reimbursement; insurance transparency prudent lay person standard; ACA (coverage of essential health benefits); H.R.2; H.R.4015; S.2694; H.R.5723; S.3040; HR 1625; Repeal & Replace of ACA; insurance market stabilization.

Client expense: $72,500 · Firm income: Not reported

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

Provider Enrollment; Medicare and Medicaid; Medicare-Medicaid for Primary Care; Reimbursement including Out-of-Network Payments/Out-of-Network Reimbursement; H.R.2; H.R.4015; S.2694; H.R.5723; S.3040; Repeal & Replace of ACA; insurance market stabilization.

Client expense: $72,500 · Firm income: Not reported

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

Provider Enrollment; Medicare and Medicaid; Medicare-Medicaid for Primary Care; Reimbursement including Out-of-Network Payments/Out-of-Network Reimbursement; H.R.2; H.R.4015; S.2694; H.R.5723; S.3040; Repeal & Replace of ACA; insurance market stabilization.

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

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

Provider Enrollment; Medicare and Medicaid; Medicare-Medicaid for Primary Care; Reimbursement including SGR an Out-of-Network Payments/Out-of-Network Reimbursement; H.R.2; H.R.4015; S.2694; H.R.5723; S.3040; Balance Billing; Repeal & American Healthcare Act/Better Care Reconciliation Act H.R.1628

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

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

Provider Enrollment; Medicare and Medicaid; Medicare-Medicaid for Primary Care; Reimbursement including SGR an Out-of-Network Payments/Out-of-Network Reimbursement; H.R.2; H.R.4015; S.2694; H.R.5723; S.3040; Balance Billing; Repeal & Replace of ACA

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

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

Provider Enrollment; Medicare and Medicaid; Medicare-Medicaid for Primary Care; Reimbursement including Out-of-Network Payments/Out-of-Network Reimbursement; H.R.2; H.R.4015; S.2694; H.R.5723; S.3040; Repeal & Replace of ACA; insurance market stabilization.

Client expense: $72,500 · Firm income: Not reported

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

Provider Enrollment; Medicare and Medicaid; Medicare-Medicaid for Primary Care; Reimbursement including Out-of-Network Payments/Out-of-Network Reimbursement; H.R.2; H.R.4015; S.2694; H.R.5723; S.3040; Repeal & Replace of ACA; insurance market stabilization.

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

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

Provider Enrollment; Medicare and Medicaid; Medicare-Medicaid for Primary Care; Reimbursement including SGR an Out-of-Network Payments/Out-of-Network Reimbursement; H.R.2; H.R.4015; S.2694; H.R.5723; S.3040; Balance Billing; Repeal & American Healthcare Act/Better Care Reconciliation Act H.R.1628

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

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

Provider Enrollment; Medicare and Medicaid; Medicare-Medicaid for Primary Care; Reimbursement including SGR an Out-of-Network Payments/Out-of-Network Reimbursement; H.R.2; H.R.4015; S.2694; H.R.5723; S.3040; Balance Billing; Repeal & Replace of ACA

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

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