The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from May 3 – May 9. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
NON-CORONAVIRUS LEGISLATIVE UPDATE
House
On May 4, the Oversight & Reform Economic & Consumer Policy Subcommittee held a hearing The Urgent Need to Reform the Organ Transplantation System to Secure More Organs for Waiting, Ailing, and Dying Patients. House lawmakers are warning organ collection agencies to make more organs available for transplant and cut down on racial disparities among donors and recipients or face tighter regulation. Witnesses included: Tonya Ingram, patient waiting for a transplant; Dara Kass, living donor and mother of transplant recipient; LaQuayia Goldring, patient waiting for a transplant; Steve Miller, CEO, Association for Organ Procurement; Joe Ferreira, President Association for Organ Procurement; Matt Wadsworth, President, CEO, Life Connection of Ohio; Seth Karp, MD, Director, Vanderbilt Transplant Center; and Donna Cryer, President, CEO, Global Liver Institute.
On May 4, the Energy & Commerce Health Subcommittee held a hearing Negotiating a Better Deal: Legislation to Lower the Cost of Prescription Drugs. Legislation considered included:
H.R. 3, the "Elijah E. Cummings Lower Drug Costs Now Act";
H.R. 19, the "Lower Costs, More Cures Act of 2021";
H.R. 153, the "Protecting Consumer Access to Generic Drugs Act of 2021";
H.R. 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" or the "BIOSIM Act";
H.R. 2831, the "Prompt Approval of Safe Generic Drugs Act";
H.R. 2843, the "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" or the "STOP GAMES Act";
H.R. 2846, to amend title XVIII of the Social Security Act to require sponsors of a prescription drug plan under Part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes; and
H.R. 2853, the "Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021" or the "BLOCKING Act."
Witnesses included: Therese Ball, patient; Michael Carrier, Distinguished Professor of Law, Rutgers Law School; Rachel Sachs, Associate Professor of Law, Washington University in St. Louis School of Law; Gaurav Gupta, M.D., Founder, Ascendant BioCapital; and Khrystal Davis, Rare Disease Caregiver & Patient Advocate, Texas Rare Alliance Founding President.
On May 5, the Education & Labor HELP Subcommittee held a hearing entitled Lower Drug Costs Now: Expanding Access to Affordable Health Care. Members highlighted the impact of high drug prices on patients and businesses. Rep. Diana Harshbarger (R-TN) noted that since coinsurance is calculated from the list price, not the net price, the difference is negatively impacting patients. Subcommittee Chairman Mark DeSaulnier (D-CA) and other members noted that H.R. 3 would help patients reduce the costs of life saving drugs while not impacting innovation. Subcommittee Ranking Member Rick Allen (R-GA) and other Republican members also warned that H.R. 3 could lead to greater reliance on China for drug development and manufacturing and would adversely impact innovation. Witnesses included: Mariana Socal, MD, Associate Scientist, Johns Hopkins Bloomberg School of Public Health; David Mitchell, Founder, President, Patients For Affordable Drugs Now; Douglas Holtz-Eakin, President, American Action Forum; and Frederick Isasi, Executive Director, Families USA.
On May 6, the Energy & Commerce Communications and Technology Subcommittee held a hearing Broadband Equity: Addressing Disparities in Access and Affordability. Chairman Frank Pallone (D-NJ) called for greater public investment in broadband. Witnesses included: Joi Chaney, Executive Director, Washington Bureau & Senior Vice President for Advocacy and Policy, National Urban League; Chris Lewis, President and CEO, Public Knowledge; Francella Ochillo, Executive Director, Next Century Cities; and George Ford, Chief Economist, Phoenix Center for Advanced Legal & Economic Public Policy Studies
On May 3, the Appropriations Committee released a list of legislator’s requested earmarks.
On May 6, Appropriations Chair Rosa DeLauro (D-CT) predicted that the FY 2022 government spending bills will be scheduled for subcommittee and full committee markup next month, and the bills will be passed in July. Chair DeLauro noted that the committee has received more than 300 earmark requests.
On May 6, Majority Leader Steny Hoyer (D-MD) predicted that the chamber will take up legislation addressing mental health needs, debt collection reform, and the Pregnant Workers Fairness Act when the House returns to session.
The House will consider the following health-related bills on May 11:
H.R. 433 – Family Support Services for Addiction Act of 2021;
H.R. 1475 – Pursuing Equity in Mental Health Act;
H.R. 586 – STANDUP Act of 2021;
H.R. 721 – Mental Health Services for Students Act of 2021, as amended;
H.R. 2877 – Behavioral Intervention Guidelines Act of 2021;
H.R. 1260 – Bipartisan Solution to Cyclical Violence Act of 2021;
H.R. 1205 – Improving Mental Health Access from the Emergency Department Act of 2021;
H.R. 1324 – Effective Suicide Screening and Assessment in the Emergency Department Act of 2021;
H.R. 1480 – HERO Act;
H.R. 2862 – Campaign to Prevent Suicide Act;
H.R. 2981 – Suicide Prevention Lifeline Improvement Act of 202
H.R. 2955 – Suicide Prevention Act; and
H.R. 1629 – Fairness in Orphan Drug Exclusivity Act.
Senate
None of note.
NON-CORONAVIRUS REGULATORY UPDATE
On May 3, the Food & Drug Administration (FDA) announced it will issue FY 2022 program fee invoices for Prescription Drug User Fee Act fee-eligible products in August and requested that companies list fee-eligible products by June 1.
On May 3, the U.S. Department of Health & Human Services (HHS) announced it will be partnering with national organizations to support and enhance outreach and enrollment efforts for Asian American and Pacific Islander (AAPI) during the HealthCare.gov Special Enrollment Period, as part of the AAPI Week of Action. HHS and partnering organizations will provide education and enrollment assistance to AAPI consumers and use social media to encourage them to enroll in health coverage through HealthCare.gov.
On May 5, the FDA announced that COVID-19 will prevent the agency from conducting planned medical surveillance inspections in FY 2021.
On May 5, the Centers for Medicare & Medicaid Services (CMS) debuted the first social media videos to combat vaccine hesitancy, featuring long-term care community staff who moved from being initially uncertain about receiving the COVID-19 vaccine to accepting the vaccine, and encouraging their peers to do the same.
On May 5, the White House Office of Management & Budget (OMB) received the final rule entitled Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary" (CMS-3372). The rule was earlier finalized by the Trump administration and was set to go into effect on March 15. The Biden administration delayed the rule until May 15 in order to conduct an additional 30-day comment period. The rule sent to OMB will address these comments and, as a result, may make modifications to the rule.
On May 5, CMS announced that CMS’ Center for Medicare & Medicaid Innovation (CMMI) Part D Payment Modernization Model (PDM) will conclude on December 31, 2021. CMMI will not proceed with testing the PDM Model in CY 2022 through CY 2024, as initially planned. The Model began in January 2020 to test how changes in Part D benefit design and incentives would affect overall Part D prescription drug spending and beneficiary out-of-pocket costs.
On May 6, CMS reported that 939,575 Americans have signed up for health insurance through HealthCare.gov between February 15 and April 30. A fact sheet on the report is available here.
On May 6, OMB concluded its review of the interim final rule entitled COVID-19 Vaccine Immunization Requirements for LTC Residents and Staff (CMS-3414).
The National Clinical Care Commission will hold a meeting May 19 and June 1, 2021 to evaluate and make recommendations regarding improvements to the coordination and leveraging of federal programs related to diabetes and its complications.
NON-CORONAVIRUS WHITE HOUSE UPDATE
None of note.
CORONAVIRUS UPDATE
House
On May 4, 12 Republican Members from the Judiciary Courts, Intellectual Property, and the Internet Subcommittee urged U.S. Trade Representative Katherine Tai to oppose the proposed World Trade Organization waiver of certain intellectual property obligations for COVID-19 vaccines and medicines under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Nevertheless, on May 5, Tai announced that the U.S. will indeed support the TRIPS waiver noting that “extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures.”
Senate
None of note.
Regulatory
On May 3, Health Resources & Services Administration (HRSA) announced the COVID-19 Coverage Assistance Fund to cover the costs of administering COVID-19 vaccines to patients enrolled in health plans that either do not cover vaccination fees or cover them with patient cost-sharing. On May 4, HRSA also announced $250 million to develop and support a community-based workforce to share information about vaccines, increase COVID-19 vaccine confidence, and address any barriers to vaccination for individuals living in vulnerable and medically underserved communities.
On May 4, HRSA announced $1 billion for rural clinics and hospitals to improve COVID-19 testing and increase vaccination outreach, including increasing the number of vaccines sent to rural communities, expanding testing and other COVID-19 prevention services, and working to increase vaccine confidence by empowering trusted local voices with additional funding for outreach efforts in underserved communities.
On May 5, HHS Secretary Xavier Becerra and Housing & Urban Development Secretary Marcia Fudge announced a joint-agency effort to increase access to COVID-19 prevention and treatment services, including testing and vaccinations, among disproportionately affected communities, including among HUD-assisted households and people experiencing homelessness.
On May 5, the Centers for Disease Control and Prevention (CDC) released a report finding that high vaccination coverage and compliance with nonpharmaceutical interventions, including wearing masks, are essential to control COVID-19 and prevent surges in hospitalizations and deaths.
On May 6, CMS increased the Medicare payment rate for administering monoclonal antibodies to treat beneficiaries with COVID-19 under Medicare Part B.
The CDC Advisory Committee on Immunization Practice will hold a meeting to discuss Pfizer’s COVID-19 vaccine for adolescents on May 12.
White House
On May 4, President Biden committed to a goal of sending 60 million doses of AstraZeneca vaccine to other countries over the next two months.
On May 4, President Biden announced a new vaccination goal to deliver at least one shot to 70% of adult Americans by July 4th. President Biden also announced that the Administration will soon allow states to order COVID-19 doses that other states are not using.
Other
On May 3, Moderna announced an agreement with COVAX, the global initiative working to ensure equitable access to COVID-19 vaccines, to supply up to 500 million COVID-19 vaccine doses, including an initial 34 million doses to be delivered in the fourth quarter of 2021.
On May 3, Novavax began a Phase III trial of its COVID-19 vaccine in adolescents 12 to 17.
On May 3, the European Medicines Agency announced that it is considering whether to promote the use of Pfizer’s COVID-19 vaccine in adolescents between 12 and 15.
On May 4, Moderna announced intent to file for full FDA approval for its COVID-19 vaccine this month. On May 5, Moderna also released positive Phase II data supporting its COVID-19 vaccine booster to combat COVID-19 variants and Phase II/III data showing a 96% effectiveness rate in Phase 2/3 testing of adolescents ages 12 to 17.
On May 5, Adagio Therapeutics began a Phase II/III trial of its COVID-19 antibody drug, ADG20, to prevent symptomatic COVID-19.
On May 5, a study of real-world data published in the Lancet found that the Pfizer COVID-19 vaccine was 95% effective against infection, hospitalization, and death and protects against variants. Another study of real-world data published in the New England Journal of Medicine found that the Pfizer vaccine to be 95% effective and protects against variants.
On May 5, Canada authorized the use of the Pfizer COVID-19 vaccine for adolescents 12 to 15.
On May 5, Novavax published Phase II data in the New England Journal of Medicine concluding that its COVID-19 vaccine, NVX-CoV2373, was 51% effective against the B.1.351 variant for those without HIV and 43% effective for those with HIV.
On May 5, a study published in JAMA Network found that Medicaid enrollment increased during the COVID-19 pandemic, resulting in approximately 5 million more people covered nationally by September 2020. Enrollment growth was larger in expansion states.
On May 6, Novavax announced an agreement to manufacture and distribute 350 million COVID-19 vaccine doses for COVAX.
On May 7, Pfizer announced the submission of its COVID-19 vaccine to the FDA for full approval for those 16 and older. Pfizer also submitted its vaccine for emergency use authorization for those 12 to 15.
On May 7, the World Health Organization (WHO) listed China’s Sinopharm COVID-19 vaccine for emergency use, allowing the vaccine to be administered in countries that rely on the WHO’s vaccine recommendations.
On May 7, Pfizer Chairman Albert Bourla published a letter arguing that the proposed COVID-19 vaccine patent and intellectual property TRIPS waiver could negatively impact vaccine access due to the waiver’s potential to disrupt the flow of raw materials
As of May 9, over 151 million people have received the first dose of COVID-19 vaccines (more than 112 million have received both doses) and nearly 330 million doses have been distributed, according to the CDC COVID Data Tracker.
As of May 9, the U.S. had 32,686,791 confirmed COVID-19 cases resulting in 581,517 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
RULES AT THE WHITE HOUSE OMB
HHS-CMS
Modification of Limitations on Redesignation by the Medicare Geographic Classification Review Board (CMS-1762); Interim Final Rule; Received 2/26/21
CY 2022 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1751); Proposed Rule; Received 3/30/21
Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary" (CMS-3372); Final Rule; Received 5/5/21
CY 2022 Home Health Prospective Payment System Rate Update, Home Infusion Therapy Services, and Quality Reporting Requirements (CMS-1747); Proposed Rule; Received 4/30/21
REPORTS
HHS Office of Inspector General (OIG)
On May 5, OIG released a report entitled Medicare Hospital Provider Compliance Audit: Virtua Our Lady of Lourdes Hospital. The report found that the hospital did not always comply with Medicare billing requirements for inpatient and outpatient claims, resulting in an estimated $4.8 million in overpayments. OIG recommended that the hospital refund overpayments to the Medicare contractor and strengthen controls to ensure full compliance with Medicare requirements. The hospital generally disagreed with OIG’s findings and recommendations. A summary of the report is available here.
On May 6, OIG released a report entitled CMS Could Improve the Data It Uses To Monitor Antipsychotic Drugs in Nursing Homes. The report found that CMS' use of the Minimum Data Set (MDS) as the sole data source to count the number of nursing home residents using antipsychotic drugs may not always provide complete information, including MDS not always resulting in a complete assessment of the number of residents who are prescribed antipsychotic drugs and other details about the drug use. The report suggests that CMS could enhance the information it uses to monitor antipsychotics in nursing homes by using additional data sources in its measurement of this complex issue that is critical for resident health and safety. OIG recommended that CMS take additional steps to validate the information reported in MDS assessments and supplement the data it uses to monitor the use of antipsychotic drugs in nursing homes. CMS agreed with both recommendations. A summary of the report is available here.
On May 7, OIG released a report entitled The Substance Abuse and Mental Health Services Administration Generally Had Controls and Strategies for Mitigating Disaster Preparedness and Response Risks. OIG identified eight sub-risk areas within SAMHSA's disaster preparedness and response activities, including: operating structure and reporting lines, roles and responsibilities, strategic focus, legal or regulatory compliance, grantee selection, grant award process, grantee challenges, and grantee monitoring. OIG assessed SAMHSA's disaster preparedness and response activities as moderate risk. OIG recommended that SAMHSA mitigate its governance risk by formally documenting its full organizational structure. SAMHSA officials concurred with the recommendation. A summary of the report is available here.
On May 7, OIG released a report entitled Louisiana Did Not Fully Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities. The report found that Louisiana did not fully comply with Federal Medicaid waiver and State requirements for reporting and monitoring critical incidents involving Medicaid beneficiaries with developmental disabilities residing in community-based settings. OIG recommended that Louisiana work with community-based providers on processes to identify and report all critical incidents, perform timely analytical procedures to identify unreported critical incidents, ensure that beneficiaries and their families are properly educated and understand that all hospital emergency room visits are critical incidents, track direct service providers' and support coordinators' compliance with the reporting timeframes outlined in the waiver, and correctly track whether direct service providers forward hardcopy critical incident reports to the support coordinator within 24 hours of discovery. Louisiana agreed with most of the recommendations. A summary of the report is available here.
Government Accountability Office (GAO)
On May 3, GAO announced new Medicaid and CHIP Payment and Access Commission (MACPAC) appointments, reappointments, and the Commission’s Chair and Vice Chair:
Melanie Bella for Chair;
Kisha Davis for Vice Chair;
Melanie Bella and Katherine Weno were both reappointed;
Heidi L. Allen, Robert Duncan, Laura Herrera Scott, and Verlon Johnson are newly appointed members. Their terms will expire in April of 2024. Dennis Heaphy was newly appointed to serve out the remaining term of Thomas Barker, which will expire in April of 2022.
HEARINGS
House
Energy & Commerce Committee
May 12, 10:30 a.m.
Witness: HHS Secretary Becerra
Committee memo can be found here.
Ways & Means Committee
Hearing on the Biden Administration’s 2021 Trade Policy Agenda
Witness: Ambassador Katherine Tai, USTR
Oversight & Reform Committee
May 18, 10:00 a.m.
Senate
Health, Education, Labor & Pensions (HELP) Committee
An Update from Federal Officials on Efforts to Combat COVID-19
May 11, 10:00 a.m.
Witnesses include: Anthony Fauci, MD, Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health; David Kessler, MD, Chief Science Officer, COVID Response, HHS; Peter Marks, MD, Director, Center for Biologics Evaluation and Research, FDA; and Rochelle Walensky, MD, Director, CDC
Finance Committee
The COVID-19 Pandemic and Beyond: Improving Mental Health and Addiction Services in Our Communities
May 12, 3:00 p.m.
Witnesses include: Victor Armstrong, Director, North Carolina Division of Mental Health, Developmental Disabilities And Substance Abuse Services, North Carolina HHS; Stephanie Woodard, Senior Advisor On Behavioral Health, Nevada HHS; Lenette Kosovich, CEO, Rimrock Foundation; and Malkia Newman, Team Supervisor, CNS Healthcare Anti-Stigma Program.
OTHER HEALTH POLICY NEWS
On May 3, Kaiser Family Foundation released a report finding that Medicare Advantage, Medicaid managed care, individual and fully insured group markets insurers had high gross margins per member per month and low medical loss ratios, compared to recent years.
On May 4, the National Association of ACOs called for HHS Secretary Becerra to delay mandatory reporting requirements of electronic Clinical Quality Measures and Merit-based Incentive Payment System Clinical Quality Measures and to implement changes to the Medicare Shared Savings Program quality overhaul.
On May 4, the National Academies of Sciences, Engineering and Medicine released a report recommending that all Americans select a primary care provider or be assigned one and that the federal government aggressively bolster primary care.
On May 5, a study published in Health Affairs found that private equity firms are more likely to acquire hospitals with larger operating margins, more beds, and in urban areas.
On May 5, the American Hospital Association urged HHS to extend the deadline for providers to use their COVID-19 Provider Relief Fund payments from June 30 to the end of the Public Health Emergency.
On May 6, Gallup published a study finding that 1-in-6 adult workers whose primary health insurance comes from an employer are staying in jobs they might otherwise leave due to fear of losing their health benefits.