Protecting Access to Innovation During COVID–19 Act

H.R. 2356 and S.2363, the Better Wound Care at Home Act H.R.8624 (From 116th Congress) - Protecting Access to Innovation During COVID-19 Act. H.R. 5376 - Build Back Better Act, provisions related to drug pricing.

Client expense: $400,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2356, the Better Wound Care at Home Act H.R.8624 (From 116th Congress) - Protecting Access to Innovation During COVID-19 Act. H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act

Client expense: $360,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

H.R.7127 (From 116th Congress) - To amend title XVIII of the Social Security Act to make technical amendments to the separate payment under the Medicare program for disposable negative pressure wound therapy devices. H.R.8624 (From 116th Congress) - Protecting Access to Innovation During COVID-19 Act. S.4295 (From 116th Congress) - Public Health Emergency Pass-Through Payment Fairness Act of 2020.

Client expense: $515,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

H.R. 3107 - Improving Seniors' Timely Access to Care Act of 2019 - DelBene - prior authorization in Medicare Advantage H.R. 3925 - Reducing Barriers to Substance Use Treatment Act - Tonko - Opioids H.R. 3935 - Protecting Patients Transportation to Care Act - Carter - Medicaid coverage for transportation H.R. 4453 - Protecting Seniors from Health Care Fraud Act of 2019 - Ruiz -Distributing information to Medicare beneficiaries to prevent fraud H.R. 4529 - Promoting Access to Broadband Act of 2019 - Maloney - Medicaid H.R. 4583 - Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 - Schneider - prescription drug affordability H.R. 4620 - More Help for Seniors Act of 2019 - Rose - expand eligibility for low-income subsidies under part D of the Medicare program H.R. 4621 - Collecting and Analyzing Resources Integral and Necessary for Guidance for Social Determinants Act of 2019 - Blunt Rochester - best practices re social determinants of health H.R. 4629 - Star Rating for Biosimilars Act - Tonko - biosimilars H.R. 4632 - Better Transparency in Information for Medicare Beneficiaries Act of 2019 - Kind - provides consumers information regarding premiums under LIS benchmark plans H.R. 4671 - Helping Seniors Afford Health Care Act - Kim - Medicare affordability and low income beneficiaries H.R. 4996 - Helping Medicaid Offer Maternity Services Act of 2020 - Kelly - extend Medicaid coverage post-partum H.R. 5006 - Expanding Access to Inpatient Mental Health Act - Emmer - Medicaid coverage for SUD/mental health for institutionalized H.R. 5201 - Telemental Health Expansion Act of 2019 - Matsui - Medicare coverage of mental telehealth H.R. 5232 - Road to Recovery Act - Fitzpatrick - Medicaid and CHIP SUD treatment H.R. 5693 - Primary Health Services Enhancement Act - Kind - Medicare rural health H.R. 5808 - Save Rural Communities Act of 2020 - Arrington - rural emergency medical access services under Medicare H.R. 5833 - To amend title XVIII of the Social Security Act to permit the use of certain psychological evaluation via telehealth for Medicare coverage of neurostimulation services for the treatment of chronic pain - Latta - Medicare coverage in telehealth H.R. 5882 - GENE Therapy Payment Act - Schrader - value based care H.R. 6098 - To amend title XXI of the Social Security Act to allow States to expand income eligibility standards under the Children's Health Insurance Program -Barragan - CHIP eligibility H.R. 6151 - CARING for Kids Act - Fineknauer - CHIP H.R. 6179 - Increasing Access to Biosimilars Act of 2020 - Cardenas - payments to providers of biosimilars under Medicare H.R. 6209 - Reducing Unnecessary Senior Hospitalizations Act of 2020 or the RUSH Act of 2020 -Kuster - Medicare coverage for certain services in hospital emergency departments H.R. 6244 - To amend titles XVIII and XIX to provide for coverage at no cost sharing of COVID-19 testing under the Medicaid program and Children's Health Insurance Program - Kelly - Medicaid coverage of COVID-19 related visits and testing H.R. 6263 - To amend title XVIII of the Social Security Act to waive cost sharing under the Medicare program for certain visits relating to testing for COVID-19 -Sarbanes - Medicare coverage of COVID-19 related visits and testing H.R. 6273 - Protecting Vulnerable Americans in Times of Crisis Act of 2020 - Butterfield - FMAP H.R. 6311 - Care for COVID-19 Act - Ruiz - COVID-19 cost sharing H.R. 6336 - Increasing Hospital Capacity to Fight the Coronavirus Act of 2020 - Bishop - Medicare and Medicaid payments during COVID-19 emergency H.R. 6462 - Emergency Medicaid for Coronavirus Treatment Act - Gallego - Medicaid coverage H.R. 6511 - Ensuring Vaccination and Treatment Affordability Act - Pappas - COVID H.R. 6521 - To prohibit the Secretary of Health and Human Services from taking certain actions with respect to Medicaid supplemental payments reporting requirements, and for other purposes - Diaz Barragan - Medicaid, delays implementation of MFAR H.R. 6538 - Modernized Medicine Act - Kennedy - Medicaid, Telehealth H.R. 6539 - Coronavirus Medicaid Response Act - Lee - FMAP H.R. 6572 - To direct the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, to carry out a national campaign to increase awareness and knowledge of COVID-19. -Bilirakis - COVID H.R. 6583 - To amend title XVIII of the Social Security Act to establish a risk corridor program for Medicare Advantage plans during the COVID-19 emergency, and for other purposes. - Houlahan - COVID H.R. 6616 - Stronger Medicaid Response to the COVID-19 Pandemic Act -Cardenas - COVID H.R. 6640 - Medicare Advantage COVID Treatment Act - Mucarsel-Powell - COVID H.R. 6658 - Insular Area Medicaid Coronavirus Recovery Act - Sablan - FMAP H.R. 6727 - To hold Medicare beneficiaries harmless for specified COVID-19 treatment services furnished under part A or part B of the Medicare program - Schrier - COVID H.R. 6744 - Computer and Internet Equity Act - Davis - internet access for Lifeline program H.R. 6753 - Save Rural Hospitals Act of 2020 - Finkenauer - Medicare hospital payments H.R. 6792 - Improving Telehealth for Underserved Communities Act of 2020 - Smith - telehealth H.R. 6797 - CHIPPER Act - Wild - CHIP, COVID H.R. 6837 - Medicare Accelerated and Advance Payments Improvement Act of 2020 -Schneider - COVID H.R. 7154 - Outpatient Therapy Modernization and Stabilization Act -Boyle - outpatient therapy services H.R. 7187 - HEALTH Act of 2020 -Thompson -Smith - telehealth H.R. 7292 - To amend title XVIII of the Social Security Act to provide for forgiveness of certain accelerated and advance payments under parts A and B of the Medicare program. - Kaptur - advance payments H.R. 7338 - To amend title XVIII of the Social Security Act to permit the Secretary of Health and Human Services to waive requirements relating to the furnishing of telehealth services under the Medicare program, and for other purposes. - Cheney - Telehealth H.R. 7391 - To amend title XVIII of the Social Security Act to remove certain geographic and originating site restrictions on the furnishing of telehealth services under the Medicare program - Sherrill- Telehealth H.R. 7606 - MFAR Transparency Act - Williams - report on impact of MFAR to Congress H.R. 7627 - MORE Savings Act - Dean - Medicare access to opioid treatment and MAT H.R. 7663 - Protecting Access to Post-COVID-19 Telehealth Act of 2020 - Thompson - waive or modify application of Medicare requirements with respect to telehealth during PHE H.R. 7791 - Value in Health Care Act of 2020 - Welch - Medicare shared savings program and alternative payment arrangements H.R. 7877 - Lowering Drug Costs for Seniors Act of 2020 - Katko - Medicare Part D costs H.R. 7892 - Medicaid Expansion During Crisis Act - Coleman - extend eligibility period for Medicaid enrollment application H.R. 8177 - Renal Anemia Innovation Support and Expansion Act - OHalleran - Medicare prescription drug coverage for chronic kidney disease H.R. 8218 - Rural Ambulance Reimbursement Fairness Act - Gianforte - Medicare payment for rural ambulance services H.R. 8254 - Bringing Enhanced Treatments and Therapies to ESRD Recipients Kidney Care Act - Blumenauer - integrated care for Medicare beneficiaries with ESRD H.R. 8427 - To provide for certain reports on enrollment in the Lifeline program, and for other purposes - Luria - Lifeline program H.R. 8476 - TIKES Act -Blunt Rochester - telehealth coverage in Medicaid H.R. 8505 - To amend title XVIII of the Social Security Act to provide for a one-year waiver of budget neutrality adjustments under the Medicare physician fee schedule - Burgess - Medicare physician fee schedule H.R. 8525 - Expanded Genetic Screening Act of 2020 - Speier - Medicaid coverage of non-invasive prenatal genetic screening H.R. 8529 - Protecting Access to Affordable Medicines Act of 2020 - Butterfield - rebates under the Medicaid program for certain noninnovator multiple source drugs H.R. 8546 - Fair Drug Prices for Kids Act -Wild - Medicaid drug rebate program in CHIP H.R. 8558 - Comprehensive Breast Reconstruction Act of 2020 - Hastings - extends coverage of certain breast reconstructive services following mastectomy under the Medicare and Medicaid programs H.R. 8561 - Restoring Fairness to Medicaid Reimbursement Act of 2020 - Johnson - FMAP H.R. 8574 - PROTECT Long Term Care Facilities Act -Sherrill - long term care in COVID-19 H.R. 8586 - Medicaid Coverage for Addiction Recovery Expansion Act -Foster - Substance Use Disorder H.R. 8623 - SAVE for Seniors Act - Spanberger - Medicare coverage of COVID-19 vaccines H.R. 8624 - Protecting Access to Innovation During COVID-19 Act - Wenstrup - extension of pass-through status under the Medicare program H.R. 8702 - Holding Providers Harmless From Medicare Cuts During COVID-19 Act of 2020 -Bera - part B Medicare payments during COVID H.R. 8725 - HAPI Act - Soto - Medicaid Coverage of adult vaccines H.R. 8727 - Telehealth Modernization Act - Carter - Medicare telehealth payments H.R. 8755 - Expanded Telehealth Access Act -Sherrill - Medicare telehealth coverage H.R. 8756 - COVID Health Care Provider Assurance Act of 2020 - Riggleman - Medicare Part B payments during COVID-19 H.R. 8826 - The Resetting the Impact Act (TRIA) of 2020 - Sewell - amends the IMPACT Act of 2014 H.R. 8840 - Medicare Sequester COVID Moratorium Act - Schneider - extend temporary Medicare sequestration H.R. 8871 - COVID HCBS Relief Act of 2020 - Dingell - funding for state Medicaid programs HCBS H.R. 8934 - Community Integration Act of 2020 - Cartwright - Medicaid HCBS H.R. 8958 - Supporting Best Practices for Healthy Moms Act - Kelly - guidance for state Medicaid programs on maternal health H.R. 9002 - To amend title XIX of the Social Security Act to provide States an option to cover a children's program of all-inclusive coordinated care (ChiPACC) under Medicaid program - DeGette - Childrens health under Medicaid H.R. 9006 - To amend title XIX of the Social Security Act to provide for coverage under the Medicaid program under such title of routine patient costs associated with participation in certain clinical trials - Garcia - Medicaid coverage of clinical trials H.R. 9035 - Permanency for Audio-Only Telehealth Act - Smith - Audio only telehealth in Medicare S. 2846 - Protecting Patients Transportation to Care Act - Isakson - Medicaid coverage of transportation S. 2911 - Seniors Prescription Drug Relief Act of 2019 - Cassidy - Part D smoothing S. 3013 - Encouraging Innovative Benefit Design to Lower Costs for Seniors Act - Crapo - offer additional prescription drugs under Part D S. 3220 - Ensuring Access to Direct Support Professionals Act - Portman - Medicaid coverage in acute care hospitals S. 3238 - Preventive Home Visit Act - King - preventative home visits S. 3277 - HCBS Infrastructure Improvement Act - Casey - access to community based services S. 3353 - Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2020 - Cassidy - Medicare coverage of kidney transplant services S. 3384 - Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - McSally - Medicare Part D drug pricing negotiation S. 3399 - FCHIP Extension Act - Tester - rural health S. 3442 - Care for COVID-19 Act - Booker - COVID-19 cost sharing S. 3443 - Improving Coverage and Care for Mothers Act - Casey - Medicaid coverage for all pregnant and postpartum women S. 3447 - RUSH Act of 2020 - Thune - Medicare coverage for certain services in hospital emergency departments S. 3466 - ACCESS for Biosimilars Act of 2020 - McSally - eliminates cost sharing for biosimilar biological products furnished under part B of the Medicare program S. 3615 - Rural Community Hospital Demonstration Extension Act of 2020 - Murkowski - rural community hospital demonstration program S. 3665 - Save Rural Hospitals Act of 2020 - Alexander - Medicare hospital payments S. 3750 - Medicare Accelerated and Advance Payments Improvement Act of 2020 - Shaheen - COVID S. 3881 - CHIPPER Act - Casey - CHIP, COVID S. 3998 - HEALTH Act of 2020 - Hyde-Smith - telehealth S. 3999 - Mental and Behavioral Health Connectivity Act - King - Mental Health S. 4108 - A bill to amend title XIX of the Social Security Act to increase Federal support to State Medicaid programs during economic downturns - Casey - FMAP S. 4151 - SOS: Sustaining Outpatient Services Act - Hoeven - Medicare OPPS coverage S. 4230 - Telehealth Expansion Act of 2020 - Wyden - Telehealth mental health services in Medicare S. 4274 - Legalizing Drug Discounts for Seniors Act of 2020 - Paul - exclude discounts for covered part D drugs from the anti-kickback prohibition S. 4295 - Public Health Emergency Pass-Through Payment Fairness Act of 2020 - Paul - access to drugs and devices under Medicare S. 4358 - Stronger Medicaid Response to the COVID-19 Pandemic Act - Bennet - Medicaid coverage for vaccines and treatment for COVID-19 for uninsured without cost-sharing S. 4375 - Telehealth Modernization Act - Alexander - make permanent Medicare telehealth flexibilities S. 4423 - COVID-19 Hospice Respite Care Relief Act of 2020 - Brown - Medicare hospice care S. 4448- Fair Drug Prices for Kids Act - Warner - extend Medicaid drug rebate program to CHIP S. 4574 - Bringing Enhanced Treatments and Therapies to ESRD Recipients Kidney Care Act - Young - integrated care for Medicare beneficiaries with ESRD S. 4690 - Maternal Immunization Enhancement Act - Hassan - Medicaid and maternal health S. 4705 - Maternal Immunization Coverage Act - Cassidy - Medicaid coverage S. 4717 - Accelerating Kids Access to Care Act - Grassley - Medicaid enrollment S. 4742 - CLINICAL TREATMENT Act - Burr - Medicaid coverage S. 4825 - Ensuring Access to COVID-19 Vaccines for Seniors Act - Reed - Medicare coverage of COVID-19 vaccines S. 4840 - Ensuring Parity in MA for Audio-Only Telehealth Act of 2020 -Roberts - audio-only risk adjustment in Medicare Advantage S. 4859 - Connected MOM Act - Cassidy - expanded coverage of remote physiologic devices and related services under Medicaid S. 4864 - HAPI Act - Brown - Medicaid coverage of adult vaccines S. 4944 - Equality in Medicare and Medicaid Treatment Act of 2020 - Booker - CMMI models for SDOH in Medicare/Medicaid S. 4949 - Supporting Best Practices for Healthy Moms Act - Toomey - guidance for state Medicaid programs on maternal health S. 4957 - COVID HCBS Relief Act of 2020 - Casey - funding for state Medicaid programs HCBS S. 5007 - Holding Providers Harmless From Medicare Cuts During COVID-19 Act of 2020 - Boozman - increase in Medicare part B payment S. 5044 - Bill to amend title XVIII of the SSA to establish requirement with respect to the use of prior authorization under the Medicare Advantage plans - Brown - Prior authorization S. 5077 - A bill to amend title XIX of the Social Security Act to adjust the limitations on Medicaid disproportionate share hospital payments - Cornyn - Medicaid DSH payments Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, network adequacy and provider directories, encounter data and other data-related issues, and risk adjustment data validation (RADV) audit issues including proposed RADV regulation for MA; bidding and payment issues (including MA rate assumptions, MA coding intensity, MA Secondary Payer issues, Part D reinsurance, Part D low income subsidies, Part D direct and indirect remuneration (DIR), and audits); calendar year 2021 policy and technical regulation for MA and Part D; MA and Part D proposed rule on drug pricing changes for 2020; Part D reform, out of pocket limits; issues related to Medicare for All, Medicare buy-in and public option; CMSs price transparency proposal for direct-to-consumer advertisements; issues relating to 2022 Rate Notice; Executive Orders relating to international pricing, Part D rebates, insulin costs, and importation; issues related to MLTSS; issues related to removal of safe harbor protection for rebates; issues relating to COVID-19, including testing; issues related to audio-only telehealth; issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; issues related to Medicaid presumptive eligibility and continuous eligibility; issues relating to Medicaid best price; in-home health risk assessments; Medicare Medical Loss Ratio issues; issues related to changes to prior authorization regulations, electronic documentation, and related issues; issues relating to sequestration under the Medicare Advantage and Part D programs; issues related to health insurance tax for MA and Part D plans; implications of physician fee schedule on MA; application process, audits to evaluate compliance with MA and Part D program rules, benefit design rules, enrollment rules, requirements for notice and denial forms, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff; measurement and oversight of plan performance including Special Needs Plans (SNPs); quality measures, grievance and appeals processes, fraud and abuse compliance including training; contracting issues for Dual Eligible SNPs; Federal preemption of State authority under MA and Part D programs, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, Part D coverage gap discount program, including employer group waiver plan (EGWP) issues, and other operational issues; issues raised by Part D coverage of new specialty drugs, the Part D non-interference policy and related issues (e.g., preferred pharmacy and any willing pharmacy requirements, standards for network pharmacy reimbursement, and policies regarding sponsor negotiation of pharmacy price concessions); issues related to the international price index; issues related to child and maternal health; issues related to Medicaid supplemental and disproportionate share hospital (DSH) funding; issues related to Medicaid funding for territories; issues related to medical management; issues relating to MA supplemental benefits; Medication Therapy Management Program requirements and the Center for Medicare and Medicaid Innovation (CMMI) Demonstration; MA EGWP issues; CMMI's health plan models; Part D requirements for offering basic and enhanced alternative plans; MA and Part D systems issues affecting enrollment and disenrollment processing and payment and other operational issues; issues relating to MA and Part D Star Rating system including measures, the methodology for calculating ratings, and the role of the ratings for payment purposes; implementation of the Affordable Care Act (ACA) and the Bipartisan Budget Act of 2018 changes to the Part D coverage gap; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education Program; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting initiative; issues relating to Medicare coverage policy and national coverage decisions; new payment system for physicians under MACRA, including implications for MA and Part D plans; Medicare clinical trials; Medicare/Medicaid integration for dual eligibles, including implementation of the Capitated Financial Alignment Demonstration and related issues (e.g., quality ratings); Medicaid managed care regulations and policies, including CMS's substantial revisions to the managed care regulations, mental health parity rules, the Medicaid managed care actuarial soundness standard, quality oversight, Medicaid and CHIP Payment and Access Commission (MACPAC), grievance and appeals processes, fraud and abuse compliance, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including block grants, the calculation of the federal medical assistance (federal matching) percentage (FMAP), and intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost issues affecting Medicaid health plans including issues raised by Medicaid coverage of new specialty drugs; health plan-related Childrens Health Insurance Program (CHIP) issues, including eligibility and outreach issues and CHIP reauthorization; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including Medicaid managed care organization provider tax issues; standards for electronic prescribing; implementation of Medicaid changes of interest to Medicaid health plans made in the ACA including Medicaid expansion, the managed care organization (MCO) prescription drug rebate provisions, minimum payments to primary care providers (PCPs), interactions between the Medicaid program and health insurance exchanges, and Medicaid and CHIP maintenance of effort (MOE) requirements; implications of the health insurer fee for Medicaid health plans; issues related to Medicaid Managed long-term care including home and community-based waiver services (HCBS); expanding the availability of Medicare Advantage and Medicaid health plan telemedicine programs; implications of the new non-discrimination rules for health plans participating in public programs; issues related to Medigap coverage; issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); cybersecurity; provider directories; value-based insurance design models; issues relating to prescription drug price blueprint; Part D prescriber enrollment requirements; Part D recovery audit contractor programs; issues relating to enrollment of beneficiaries with ESRD into MA plans; issues related to health homes for children with medically complex conditions; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation.