The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from March 8 - March 14. 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 March 11, Energy & Commerce Committee Chairman Frank Pallone (D-NJ) introduced H.R.1848 Leading Infrastructure For Tomorrow’s America (LIFT America) Act, which would modernize the nation’s infrastructure, rebuild the economy, combat climate change, and protect public health and the environment. The bill includes the following expansions of broadband access:
$80 billion for the deployment of secure and resilient high-speed broadband to expand access nationwide;
$15 billion in grants for the deployment and implementation of Next Generation 9-1-1 services across the country to protect American lives;
$9.3 billion for broadband affordability and adoption; and
$5 billion in federal funding for low-interest financing of broadband deployment.
The bill includes the following investments in health infrastructure:
$10 billion in funding to reestablish the Hill-Burton hospital infrastructure program for construction and modernization of hospitals and medical facilities;
$10 billion in funding for community health center capital project grants;
$7 billion in investments for core public health infrastructure for State, local, Tribal, and territorial health departments and the Centers for Disease Control and Prevention (CDC);
$5 billion for the Indian Health Service for the planning, design, construction, modernization, and renovation of hospitals and health care facilities;
$4.5 billion to improve laboratory infrastructure; and
$500 million for community-based care centers that address COVID-19 and other public health crises.
A summary of the bill is available here.
On March 12, Budget Chairman John Yarmuth (D-KY) introduced H.R. 1868 to extend the Medicare sequester moratorium that expires on March 31 through the end of the year and to waive the PAYGO scorecard for the newly signed American Rescue Plan Act of 2021 so that it does not create an additional sequester cut, including $36 billion in cuts to the Medicare program. The House is expected to consider this legislation the week of March 15.
Senate
On March 8, Sen. Roy Blunt (R-MO) announced that he will not run for reelection in 2022.
On March 10, Health, Education, Labor, & Pensions (HELP) Committee Chair Patty Murray (D-WA) re-introduced the Public Health Infrastructure Saves Lives Act that would establish a $4.5 billion fund to build and maintain the nation's public health infrastructure.
On March 10, the Senate confirmed Merrick Garland to be Attorney General.
On March 10, the Homeland Security & Governmental Affairs Committee advanced the nomination of Shalanda Young for Office of Management and Budget (OMB) deputy director in a 7-6 partisan vote. On March 10, the Budget Committee also advanced Young’s nomination.
On March 11, the Senate advanced Xavier Becerra's nomination for Health & Human Services (HHS) Secretary in a 51-48 vote, with Sen. Susan Collins (R-ME) joining all Democrats in the vote. The final confirmation vote is expected next week.
NON-CORONAVIRUS REGULATORY UPDATE
On March 8, the Centers for Medicare & Medicaid Services (CMS) Center for Medicare & Medicaid Innovation (CMMI) announced that they are delaying the start dates of the Kidney Care Choices Modeland the Primary Care First Model Options.
On March 9, HHS issued a 45-day extension of the public comment period for the proposed rule entitled Modifications to the Health Insurance Portability and Accountability Act Privacy Rule to Support, and Remove Barriers to, Coordinated Care and Individual Engagement. The comment period will now run to May 6, 2021.
On March 9, Health Resources & Services Administration (HRSA) again delayed the effective date of the final rule entitled Implementation of Executive Order (EO) on Access to Affordable Life-Saving Medications, in accordance with the Biden Administration’s “regulatory freeze” memo. The rule would require health centers participating in the 340B program to make insulin and injectable epinephrine available to low-income patients or below the same price the health center paid through the 340B program. The rule is now delayed until July 20, 2021.
On March 11, the Food & Drug Administration (FDA) issued a notice of comment request regarding Prescription Drug Marketing; Administrative Procedures, Policies, and Requirements.
On March 12, CMS announced the list of CMS’ Emergency Triage, Treat, and Transport Model participants. This payment model aims to provide greater flexibility to ambulance care teams to address emergency health care needs of Medicare fee-for-service beneficiaries following a 911 call. CMS also issued a Notice of Funding Opportunity of up to $34 million over two years for local and state governments to expand emergency and non-emergency medical triage services in locations of model participants. A summary of the model is available here.
On March 12, CMS delayed the effective date of the Trump-era final rule titled on Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” until May 15, in accordance with the “regulatory freeze” memo. CMS also holding a 30-day comment period on the rule. The rule establishes the new Medicare Coverage of Innovative Technology (MCIT) pathway aimed at providing beneficiaries faster access to “breakthrough” devices. The MCIT pathway allows four years of national Medicare coverage starting on the date of FDA market authorization or a manufacturer chosen date within two years thereafter. The rule also implements regulatory criteria to be used in making “reasonable and necessary” Medicare coverage determinations for items and services under Part A and Part B.
The FDA will host a meeting entitled Roadmap to 2030 for New Drug Evaluation in Older Adults on March 23.
The FDA will host meetings entitled Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards on April 7.
NON-CORONAVIRUS WHITE HOUSE UPDATE
On March 2, President Biden announced a series of appointments and nominations:
Faisal Amin for Deputy Director of Management and Administration and the Office of Administration;
Dana Rosenzweig for Deputy Director of Management and Administration for Operations;
Clare Martorana for Federal Chief Information Officer and administrator of the Office of Electronic Government at OMB; and
Melanie Egorin for HHS Assistant Secretary for Legislation.
On March 9, White House Chief of Staff Ron Klain said Shalanda Young is a “very serious candidate for the lead position” of OMB Director, after President Biden withdrew Neera Tanden’s nomination on March 2.
CORONAVIRUS UPDATE
House
On March 9, the Appropriations Agriculture, Rural Development, FDA, and Related Agencies Subcommittee held a hearing entitled FDA's Foreign Drug Inspections Program. Chairman Sanford Bishop (D-GA) voiced concern regarding dangerous foreign drug manufacturing practices and weaknesses in foreign drug oversight. Witnesses included: Mary Denigan-Macauley, Director, Health Care, Public Health & Private Markets, Government Accountability Office (GAO).
On March 11, the Appropriations Committee Labor, HHS, Education and Related Agencies Subcommittee held a hearing entitled COVID-19 and the Mental Health and Substance Use Crises. Chair Rosa DeLauro (D-CT) highlighted the impact of mental illness on children and other vulnerable populations. Chair DeLauro advocated for long term investment in the behavioral health system, including expanding the behavioral health workforce. Witnesses included: Mark Stringer, Director, Missouri Department of Mental Health; Arthur Evans Jr., CEO and executive vice president, American Psychological Association; Verna Foust, CEO, Red Rock Behavioral Health Sciences; Lisa Amaya-Jackson, Co-director, UCLA-Duke University National Center for Child Traumatic Stress.
On March 11, President Biden signed H.R. 1319, the American Rescue Plan Act of 2021, into law. On March 10, the House voted 220-211 to approve with Senate Amendments, with Rep. Jared Golden (D-ME) and all Republicans voting against the bill. CBO released an Estimated Budgetary Effects report available here. According to an HHS fact sheet, the legislation:
Reduces the cost of health care coverage for 9 million consumers currently receiving financial assistance by ensuring consumers eligible for premium tax credits have at least a couple plans to choose from that won’t cost more than 8.5% of their household income on their Marketplace plan premium per year;
Expands the number of people eligible to save money on their health care coverage;
Addresses racial health inequities by expanding coverage and reducing costs; and
Expands access to health insurance coverage and improving access to mental health services and community-based programs that address social determinants of health.
A summary of the legislation is available here.
Senate
On March 9, the HELP Committee held a hearing entitled Examining Our COVID-19 Response: An Update from the Frontlines. Chair Patty Murray (D-WA) emphasized how investments in testing, vaccines, and health care in the American Rescue Plan will help address the effects of the COVID-19 pandemic. Chair Murray also emphasized the importance of promoting vaccine equity. Ranking Member Richard Burr (R-NC) underscored the role of state and local officials in leading the response to COVID-19 and urged the Committee to exercise proper oversight of the ongoing response efforts. Witnesses included: Jerry Abraham, M.D., Director, Kedren Health Vaccines; Umair Shah, Secretary of Health, State of Washington; Ashish Jha, M.D., Dean, Brown University School of Public Health; and Mary Ann Fuchs, VP of Patient Care, Duke University Health System.
Regulatory
On March 9, the CDC released updated guidance for those fully vaccinated against COVID-19. The guidance allows those fully vaccinated to gather indoors with fully vaccinated people without wearing a mask; gather indoors with unvaccinated, not-at-risk people from one other household; and not quarantine after being exposed to someone with COVID-19, unless they have symptoms. The guidance still advocates for those vaccinated to wear masks and abide by other COVID-19 safety measures.
On March 8, the HHS Office of Minority Health announced the Advancing Health Literacy to Enhance Equitable Community Responses to COVID-19 initiative to invest $250 million in rural and urban communities to encourage COVID-19 safety and vaccination among underserved populations.
On March 8, National Institute Of Allergy And Infectious Diseases (NIAID) Director Dr. Anthony Fauci highlighted National Institutes of Health efforts to develop direct-acting antivirals as a potential treatment to protect against COVID-19, a similar strategy used to develop HIV treatments.
On March 10, CMS and the CDC issued updated guidance for nursing homes to safely expand visitation options during the COVID-19 pandemic public health emergency. The new guidance allows responsible indoor visitation and encourages visitors to be vaccinated, though vaccination is not required. A fact sheet on the guidance is available here.
On March 11, HRSA and the CDC announced that an additional 700 HRSA-supported health centers will be invited to join the Health Center COVID-19 Vaccine Program to increase efforts to equitably distribute COVID-19 vaccines.
On March 12, HHS expanded the categories of qualified people authorized to prescribe, dispense, and administer COVID-19 vaccines including paramedics, optometrists, midwives and veterinarians, and recently retired members of all qualified professions, pharmacists, and pharmacy interns. A fact sheet on the expanded COVID-19 vaccinator eligibility is available here. HHS also launched a portal for medical professionals to check their eligibility.
HHS will hold a COVID-19 Health Equity Task Force virtual meeting on March 26.
White House
On March 8, Andy Slavitt announced that he will be leaving his position as COVID-19 Response Coordinator Senior Adviser at the end of May.
On March 10, President Biden announced plans to order another 100 million doses of Johnson & Johnson’s COVID-19 vaccine.
On March 11, President Biden launched the National Strategy for the COVID-19 Response and Pandemic Preparedness, a comprehensive strategy to address the COVID-19 pandemic. This plan includes: ordering states to make COVID-19 vaccines available to all American adults by May 1, making it easier for individuals to find a vaccine near them and address some of the barriers to getting vaccinated, providing clear guidance to vaccinated Americans, reopening schools, and continuing to combat the spread of variants including expanding testing and genomic sequencing. A summary of the plan is available here.
On March 12, President Biden announced a partnership with Australia, India and Japan, known as the “Quad” partners, to expand COVID-19 vaccine manufacturing in 2021, and strengthen and assist Indo-Pacific countries with vaccination. A fact sheet on the partner’s initiatives is available here.
Other
On March 8, a letter from Pfizer and the University of Texas published in the New England Journal of Medicine found that lab experiments showed that the Pfizer COVID-19 vaccine is able to neutralize COVID-19 strains from Brazil and U.K. at a “roughly equivalent” level and showed “robust but lower” protection against the variant from South Africa.
On March 8, the Rockefeller Foundation released an action plan entitled Accelerating National Genomic Surveillance to accelerate the development of a national system for gathering and sharing information on COVID-19 variants. The Foundation also released a report entitled the Implementation Framework: Toward a National Genomic Surveillance Network that identifies key barriers to implementing a national genomic surveillance system and outlines how to reduce these barriers.
On March 8, SCAN Health Plan released survey results entitledVaccine Refusal Among Rural Family Caregivers Is More Than Double Urban and Suburban Counterparts. The survey found that nearly one in three family caregivers who live in rural communities say they won’t take the older adult under their care to get the COVID-19 vaccine and won’t get vaccinated themselves. This compares to the one in six Urban and suburban caregivers that say they won’t take the older adult under their care to get the COVID-19 vaccine. This survey also found that safety concerns drive caregivers’ unwillingness to get the vaccine and reflects the barriers to getting vulnerable seniors in these communities vaccinated.
On March 10, a study published in in JAMA Network Open found that health care workplace factors, including workplace role, environment, or contact with patients with known COVID-19 did not increase risk of contracting COVID-19, providing reassurance that current infection prevention practices in health care are effective in preventing the transmission of COVID-19.
On March 10, Lilly announced new data from a Phase III study supporting its COVID-19 antibody therapy of bamlanivimab and etesevimab reduced COVID-19 related hospitalizations and deaths in high-risk patients.
On March 10, Pfizer announced plans to produce 2 billion doses of their COVID-19 vaccine in 2021 and could dramatically increase output by 2022 if needed.
On March 10, GlaxoSmithKline announced that an Independent Data Monitoring Committee found its COVID-19 monoclonal antibody treatment, VIR-7831, for those at high risk of hospitalization is highly effective. GlaxoSmithKline plans to pursue FDA authorization.
On March 10, a study published in the British Medical Journal found that the COVID-19 variant from the U.K., B.1.1.7, is between 30% and 100% more deadly than other variants.
On March 10, Moderna announced that the first participants received its modified COVID-19 booster vaccine as part of its Phase II trial.
On March 10, the Coalition for Epidemic Preparedness Innovations launched a $3.5 billion five-year campaign to reduce the future risk of pandemics and epidemics and cut vaccine development for new pandemics to 100 days.
On March 11, Denmark, Norway, and Iceland halted the distribution of the AstraZeneca vaccines after reports of blood clotting after vaccination. The World Health Organization’s Global Advisory Committee on Vaccine Safety announced it still supports the distribution of the AstraZeneca vaccine but is investigating the reports.
On March 11, Novavax announced results from its Phase III U.K. trial, that its COVID-19 vaccine, NVX‑CoV2373, is 96.4% effective in preventing COVID-19. The company’s Phase IIb trial found that the vaccine is 55.4% effective against the COVID-19 variant from South Africa.
On March 11, the Ad Council launched a public service campaign with multiple former Presidents urging Americans to get vaccinated against COVID-19. Former President Trump and First Lady Melania Trump did not participate in the campaign.
On March 11, Pfizer released real-world evidence from Israel demonstrating that its vaccine is 94% effective in preventing asymptomatic infections and 87% effective in preventing symptomatic COVID-19.
On March 12, Sanofi announced the start of the Phase I/II COVID-19 vaccine clinical trial for the second COVID-19 vaccine it has in development, MRT5500.
As of March 14, nearly 69 million people have received the first dose of COVID-19 vaccines (nearly 37 million have received both doses) and nearly 136 million doses have been distributed, according to the CDC COVID Data Tracker.
As of March 11, the U.S. had 29,401,167 confirmed COVID-19 cases resulting in 534,315 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
RULES AT THE WHITE HOUSE OMB
HHS-CMS
FY 2022 Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals, and the Long-Term Care Hospital Prospective Payment System (CMS-1752); Proposed Rule; Received 2/16/21
FY 2022 Skilled Nursing Facility (SNFs) Prospective Payment System Rate Update and Quality Reporting Requirements (CMS-1746); Proposed Rule; Received 2/25/21
FY 2022 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1750); Proposed Rule; Received 2/25/21
FY 2022 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Requirements (CMS-1748); Proposed Rule; Received 2/25/21
Modification of Limitations on Redesignation by the Medicare Geographic Classification Review Board (CMS-1762); Interim Final Rule; Received 2/26/21
FY 2022 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS-1754); Proposed Rule; Received 2/26/21
REPORTS
HHS Office of Inspector General (OIG)
On March 8, OIG released a report entitled Peninsula Regional Medical Center: Audit of Medicare Payments for Polysomnography Services. The report found that Peninsula Regional Medical Center submitted Medicare claims for some polysomnography services that did not comply with Medicare billing requirements, resulting in $66,647 in overpayments. OIG recommended that Peninsula Regional Medical Center refund overpayments for incorrectly billed claims and implement policies and procedures to ensure that Medicare claims for polysomnography services comply with Medicare requirements. Peninsula concurred with our findings and recommendations. A summary of the report is available here.
On March 8, OIG released a report entitled Florida Did Not Ensure That Nursing Facilities Always Reported Allegations of Potential Abuse or Neglect of Medicaid Beneficiaries and Did Not Always Assess, Prioritize, or Investigate Reported Incidents. The report found that Florida did not ensure that nursing facilities always reported potential abuse or neglect of Medicaid beneficiaries transferred from nursing facilities to hospital emergency departments. Specifically, OIG found that Florida lacked written policies and procedures for processing incident reports, had inadequate intake staffing, had inadequate incident report processing, lacked written policies and procedures for managing late incident report filings, and lacked written policies and procedures for managing Adult Protective Services abuse and neglect investigation notifications. OIG recommended that Florida work with CMS to provide clear guidance to nursing facilities regarding what constitutes a reportable incident, establish procedures to require assessment start and end dates and priority level assignments, and establish and implement written policies and procedures for incident report processing. OIG also made recommendations to improve the effectiveness of the complaint and incident report process. Florida Agency for Health Care Administration partially concurred with six of our seven recommendations. A summary of the report is available here.
On March 11, OIG released a report entitled CMS Use of Data on Nursing Home Staffing: Progress and Opportunities To Do More. The report found that CMS has taken important steps to build a new source for data on nursing home staffing and to use these data to better inform consumers and improve nursing home oversight. CMS has opportunities to better use the staffing information that nursing homes report. OIG acknowledged the impact that COVID-19 has had on nursing home oversight and on CMS' priorities to help improve the quality of care that nursing homes provide. OIG recommended that CMS provide data to consumers on nurse staff turnover and tenure, ensure the accuracy of non-nurse staffing data used on Care Compare, consider residents' level of need when identifying nursing homes for weekend inspections, and take additional steps to strengthen oversight of nursing home staffing. A summary of the report is available here.
Congressional Budget Office (CBO)
On March 8, CBO released a report entitled Monthly Budget Review: February 2021. The report estimates that the federal budget deficit was $1,048 billion in the first five months of fiscal year 2021, $423 billion more than the deficit during the same period last year. CBO also found that outlays were 25% higher and revenues were 5% higher from October through February than during the same period in FY 2020. A summary of the report is available here.
UPCOMING HEARINGS
House
Appropriations Homeland Security Subcommittee
The Role of FEMA and Emergency Management in COVID-19 Response
March 16, 10:00 a.m., Cisco WebEx
Witnesses include: Curtis Brown, State Coordinator and Co-Founder, Virginia Department of Emergency Management and Institute for Diversity and Inclusion in Emergency Management; Bob Fenton, Senior Official Performing the Duties of FEMA Administrator, Federal Emergency Management Agency; Mark Ghilarducci Director, California Governor's Office of Emergency Services; Kevin McGowan, Director, Los Angeles County Office of Emergency Management; and Patrick Sheehan, Director, Tennessee Emergency Management Agency.
Energy and Commerce Oversight and Investigation Subcommittee
Leading the Way Forward: Biden Administration Actions to Increase COVID-19 Vaccinations
March 17 10:00 a.m., Cisco WebEx
Witnesses include: Anthony Fauci, MD, Director, NIAID; Rochelle Walensky, MD, Director, CDC; and Peter Marks, Director, Center for Biologics Evaluation and Research, FDA.
Senate
Health, Education, Labor, and Pensions
March 17, 9:30 a.m., 430 Dirksen Senate Office Building
Finance Committee
A National Tragedy: COVID-19 in the Nation's Nursing Homes
March 17, 10:00 a.m.
Witnesses include: David Gifford, Chief medical officer, American Health Care Association; John Dicken, Director of health care, GAO; R. Tamara Konetzka, Professor of public health sciences, University of Chicago Department Of Public Health Sciences.
Health, Education, Labor, and Pensions
Examining Our COVID-19 Response: An Update from Federal Officials
March 18, 10:00 a.m., 216 Hart Senate Office Building
Witnesses included: Anthony Fauci, MD, Director, NIAID, National Institutes of Health; David Kessler, MD, Chief Science Officer, COVID Response, HHS; Peter Marks, MD, Director, Center for Biologics Evaluation and Research, FDA: Rochelle Walensky, MD, Director, CDC.
OTHER HEALTH POLICY NEWS
On March 9, the California Tribal Families Coalition, the American Lung Association, the National Association of Pediatric Nurse Practitioners, the Center for Science in the Public Interest, and other groups filed a lawsuit against HHS over the final rule entitled Securing Updated and Necessary Statutory Evaluations Timely, also known as the Sunset Rule. The rule sets self-executing expiration dates for existing regulations unless the department reviews them. The lawsuit says that the rule “creates incalculable costs and chaos,” directly harms Plaintiffs and the general public, and creates immediate uncertainty and instability throughout the healthcare system.
On March 9, Six former FDA Commissioners, Scott Gottlieb, Robert Califf, Mark McClellan, Margaret Hamburg, Jane Henney, and Andrew von Eschenbach, urged President Biden to nominate an FDA Commissioner, especially considering the Commissioner’s importance in combating the COVID-19 pandemic. Janet Woodcock is the current FDA Acting Commissioner and though the former Commissioners do not endorse a specific candidate, they praised Woodcock.
On March 11, the Supreme Court canceled planned oral arguments regarding the Medicaid work requirement lawsuit but the court has yet to dismiss the case.