The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from March 22 - March 28. 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 23, Speaker Nancy Pelosi (D-CA) indicated that Democrats are discussing including aspects of H.R. 3 the Elijah Cummings Lower Drug Costs Now Act to lower prescription drug prices in the next major legislative package centered on infrastructure.
On March 23, the Appropriations Labor, Health & Human Services (HHS), Education and Related Agencies Subcommittee held a hearing entitled Addressing the Maternal Health Crisis. Subcommittee Chair Rosa DeLauro (D-CT) highlighted disparities in maternal health and maternal health outcomes, and impact of social determinants of health on maternal health. Chair DeLauro also highlighted the prevalence of unexpected labor or delivery complications, compared to other wealthy nations. Witnesses included: Lisa Asare, Assistant Commissioner, Division of Family Health Services, New Jersey Department of Health; Wendy Gordon, MD, Associate Professor and Chair, Department of Midwifery, Bastyr University; Carol Sakala, MD, Director for Maternal Health, National Partnership for Women and Families; and Stacey Stewart, President, CEO, March of Dimes.
On March 23, the Energy & Commerce Health Subcommittee held a hearing entitled Building on the Affordable Care Act (ACA): Legislation to Expand Health Coverage and Lower Costs. Chairman Frank Pallone (D-NJ) highlighted expansions to the ACA included in the American Rescue Plan and the committee discussed 18 bills committee members have sponsored, including bills to address short-term plan regulations, states reinsurance programs, restoring funding to the navigator program, and strengthening Medicaid and the Children’s Health Insurance Program (CHIP). Witnesses included: Katie Keith, Associate Research Professor, Georgetown University; Dean Cameron, Director, Idaho Department of Insurance; Cindy, Mann Partner Manatt, Phelps & Phillips; Marni Jameson Carey, Executive Director, Association of Independent Doctors; and Laura LeBrun Hatcher, Board Vice President, Little Lobbyists.
On March 23, the Ways & Means Oversight Subcommittee held a hearing entitled Hearing on Examining Private Equity’s Expanded Role in the U.S. Health Care System. Chairman Bill Pascrell (D-NJ) voiced his concern regarding the lack of transparency in private equity ownership which makes proper oversight by regulators difficult and the research finding that private equity involvement is associated with poorer health outcomes. Witnesses included: Sabrina Howell, Assistant Professor of Finance, New York University, Stern School of Business; Terris King, CEO, King Enterprise Group; Ernest Tosh, Trial Attorney, Tosh Law Firm; Milly Silva, Executive Vice President, 1199 SEIU United Healthcare Workers East; and Grace Colucci, Voices for Seniors.
On March 23, Reps. Terri Sewell (D-AL), Rep. Gus Bilirakis (R-FL), Tony Cárdenas (D-CA), Brian Fitzpatrick (R-PA), Chrissy Houlahan (D-PA), Ron Kind (D-WI), Jason Smith (R-MO) and Jackie Walorski (R-IN) introduced H.R. 2166 Ensuring Parity in Medicare Advantage (MA) and Program of All-Inclusive Care for the Elderly (PACE) for Audio-Only Telehealth Act, which would allow “qualified diagnoses” to be obtained through audio-only telehealth services for MA and PACE members.
On March 22, Ways & Means Health Subcommittee member Tom Reed (R-NY) announced he would not seek reelection.
The House is in recess until April 12.
Senate
This week, the Senate voted to confirm the following members of the administration:
Vivek Murthy for Surgeon General in a 57-43 vote;
Shalanda Young for Office of Management and Budget (OMB) Deputy Director in a 63-37 vote. Young will begin her tenure as Acting Director of OMB; and
Rachel Levine for HHS Assistant Secretary of Health in a 52-48 vote.
On March 23, the Health, Education, Labor & Pensions (HELP) Primary Health and Retirement Security Subcommittee held a hearing entitled Why Does the US Pay the Highest Prices in the World for Prescription Drugs? Chair Bernie Sanders (I-VT) and Ranking Member Susan Collins (R-ME) emphasized the broad impact high drug prices have on Americans and the wider health care system. Members and witnesses proposed different policies to address the issue including: allowing Medicare to negotiate drug prices, drug importation programs, government set price ceilings, the elimination of rebates, international reference pricing strategies, U.S. government-set reference pricing based on clinical benefit, price transparency measures. Members also highlighted different bills, including: the FAIR Drug Pricing Act, the Prescription Drug Relief Act, the Medicare Drug Price Negotiation Act, the Affordable and Safe Drug Importation Act, and the Biologic Patent Transparency Act. Witnesses included: Aaron Kesselheim, MD, Professor Of Medicine, Brigham and Women’s Hospital and Harvard Medical School; Nav Persaud, MD, Canada Research Chair In Health Justice, University of Toronto; Elia Spates; and Alex Brill, Resident Fellow, AEI.
On March 23, Sens. Tammy Baldwin (D-WI), Mike Braun (R-IN), Tina Smith (D-MN) and Lisa Murkowski (R-AK) reintroduced the Fair Accountability and Innovative Research (FAIR) Drug Pricing Act, which requires drug manufacturers to notify HHS and submit a transparency and justification report 30 days before they increase the price of certain drugs (that cost at least $100) by more than 10% in one year or 25% over three years. The report will require manufacturers to provide a justification for each price increase; manufacturing, research and development costs for the qualifying drug; net profits attributable to the qualifying drug; marketing and advertising spending on the qualifying drug; and other information. A fact sheet on the legislation is available here.
On March 25, the Senate voted 90-2 to pass H.R. 1868 to extend the 2% Medicare sequester moratorium that expires on March 31 through December 31, 2021. The legislation does not include a House provision that would also waive the PAYGO scorecard to head off additional sequester cuts in 2022 created by the American Rescue Plan. In order to offset the cost of this relief, the bill would also extend cuts at the back-end of the budget window while also smoothing the current law cuts in 2030. The bill now moves onto the House where it is expected to pass.
The Senate is in recess until April 12.
NON-CORONAVIRUS REGULATORY UPDATE
On March 22, HHS announced additional Biden Administration appointments, including:
Kristina Schake for Office of the Secretary Counselor to the Secretary for Strategic Communications;
Barbara McGarey for Office of the General Counsel Deputy General Counsel;
Rebecca Haffajee for Office of the Assistant Secretary for Planning and Evaluation Principal Deputy Assistant Secretary for Planning and Evaluation;
Miranda Lynch for Office of the Assistant Secretary for Planning and Evaluation Deputy Assistant Secretary for Planning and Evaluation (Human Services Policy);
Jonathan Warsh for Office of the Assistant Secretary for Preparedness and Response Senior Policy Advisor COVID Response;
Leni Hirsch for Office of the Assistant Secretary for Preparedness and Response Special Assistant COVID Response;
Cheryl Campbell for Office of the Assistant Secretary for Administration Principal Deputy Assistant Secretary for Administration;
Stephanie Psaki for Office of Global Affairs Senior Advisor on Human Rights and Gender Equity;
Trina Dutta Substance Abuse and Mental Health Services Administration Senior Advisor; and
Subhan Cheema for COVID Response Task Force Strategic Communications Adviser.
On March 22, the Department of Justice (DOJ) submitted a brief to the Supreme Court requesting that if the Court ultimately decides to hear the dispute over Medicaid work requirements, the Court should clarify in any ruling on the merits that the HHS Secretary can still allow states to test out new measures that indirectly advance Medicaid’s main goal of providing low-income beneficiaries with health insurance. The DOJ earlier asked the court on February 22 to throw out the appeals court rulings striking down Medicaid work requirements and send the matter back to HHS.
On March 23, the Centers for Medicare & Medicaid Services (CMS) extended the Federal Marketplace Special Enrollment Period beyond the May 15 deadline to August 15. A fact sheet on the Special Enrollment expansion and changes from the American Rescue Plan is available here.
On March 23, Food & Drug Administration (FDA) Acting Commissioner Janet Woodcock announced that Deputy Commissioner Amy Abernethy will leave the agency in the coming weeks.
On March 25, CMS posted the Medicare Shared Savings Program Notice of Intent to Apply (NOIAs) and application submission dates for Accountable Care Organizations (ACO) for a January 1, 2022 start date. Beginning June 1, CMS will accept NOIAs via the ACO Management System.
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 23, the White House and HHS celebrated the 11th anniversary of the passage of the ACA.
CORONAVIRUS UPDATE
House
On March 24, Ways & Means Ranking Member Kevin Brady (R-TX), Oversight Subcommittee Ranking Member Mike Kelly (R-PA), Health Subcommittee Ranking Member Devin Nunes (R-CA), Reps. Tom Reed (R-NY), and Lloyd Smucker (R-RA) requested from HHS Secretary Xavier Becerra additional Centers for Disease Control and Prevention (CDC) National Health Safety Network information on nursing home data from New York, Pennsylvania, Michigan, New Jersey, and California. They also requested this information from the states’ respective Attorney Generals.
Senate
On March 25, the HELP Committee held a hearing entitled Examining Our COVID-19 Response: Improving Health Equity and Outcomes by Addressing Health Disparities. Chair Patty Murray (D-WA) voiced her concern regarding health inequities exacerbated by COVID-19. Chair Murray emphasized the need for better demographic data and highlighted the Committee report on health inequities that was released last year. Witnesses included: Consuelo Wilkins, MD, Vice President For Health Equity, Vanderbilt University Medical Center; Abigail Echo-Hawk (Pawnee), Executive Vice President, Seattle Indian Health Board; Taryn Mackenzie Williams, Managing Director, Poverty To Prosperity Center for American Progress; and Gene Woods, President, CEO, Atrium Health.
Regulatory
On March 23, FDA issued an Emergency Use Authorization (EUA) for Catalent to produce and ship Johnson & Johnson's (J&J) COVID-19 vaccine.
On March 24, FDA announced it will stop the distribution of Lilly’s bamlanivimab COVID-19 treatment due to the increase in COVID-19 variants that are resistant to the treatment.
On March 25, CDC launched a partnership with dialysis clinics to provide COVID-19 vaccinations to people receiving dialysis and health care personnel in outpatient dialysis clinics.
HHS postponed the COVID-19 Health Equity Task Force meeting scheduled for March 26.
White House
On March 25, the White House announced funding to expand access to vaccines and better serve communities of color, rural areas, low-income populations, and other underserved communities in the COVID-19 response, including:
$6 billion for investment in Community Health Centers to expand access to vaccines in underserved communities;
$3 billion to strengthen vaccine confidence;
$330 million to invest in community health workers;
Expand vaccine eligibility in community health centers to ACIP’s 1C eligibility tier – that includes frontline essential workers and all persons 16 years and older with high-risk medical conditions; and
Launch a partnership with dialysis clinics to provide COVID-19 vaccinations to people receiving dialysis and health care personnel in outpatient dialysis clinics.
On March 25, President Biden announced a new goal to distribute 200 million COVID-19 vaccine doses in his first 100 days after the Administration reached his goal of 100 million doses last week.
Other
On March 22, AstraZeneca announced that their COVID-19 vaccine, AZD1222, achieved a 79% efficacy preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalization from Phase III data. After the announcement, the National Institutes of Health Data and Safety Monitoring Board notified National Institute of Allergy and Infectious Diseases, Biomedical Advanced Research and Development Authority, and AstraZeneca that it was concerned by information released by the initial data from AstraZeneca, specifically that the company may have included outdated trial information. AstraZeneca quickly clarified that the March 22 data were based on a data cut-off of February 17. On March 25, AstraZeneca released additional data from its interim analysis, finding that its COVID-19 vaccine is 76% effective in preventing symptomatic COVID-19, lower than the initial analysis, and 85% effective against symptomatic COVID-19 in participants aged 65 years and over, higher than the initial analysis.
On March 22, the European Medicines Agency advised against use of ivermectin for the treatment of COVID-19, due to lack of supporting evidence. The FDA has not approved ivermectin for use in treating or preventing COVID-19.
On March 22, World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus called for COVID-19 vaccine manufacturers to license technology to other manufacturers to increase supply and help address vaccine inequity.
On March 22, DoorDash launched same-day delivery of FDA authorized COVID-19 PCR test collection kits across the nation.
On March 23, Regeneron released positive Phase III trial results showing that a lower 1,200 milligram dose of its COVID-19 antibody drug treatment, REGEN-COV, reduced the risk of hospitalization or death by 70%. The FDA issued an EUA for a dose of 2,400 milligrams of REGEN-COV back in November.
On March 23, COVAX announced it will reserve 5% of the vaccine doses it procures, up to 100 million vaccine doses by the end of 2021, as a “buffer” for conflict zones or in the case of severe outbreaks.
On March 23, Pfizer began a Phase I trial of its investigational, novel oral COVID-19 antiviral therapeutic, PF-07321332.
On March 25, Pfizer began a clinical trial to test its COVID-19 vaccine in children under 12.
On March 25, a study published in the American Journal of Obstetrics & Gynecology found that the Pfizer and Moderna vaccines are safe and effective for pregnant women, and antibodies were passed on to newborns.
On March 26, GlaxoSmithKline requested EUA from the FDA for its COVID-19 monoclonal antibody treatment, VIR-7831, for the treatment of patients with mild-to-moderate COVID-19 who are at risk for progression to hospitalization or death.
As of March 28, nearly 92 Americans people have received the first dose of COVID-19 vaccines (more than 50 million have received both doses) and more than 180 million doses have been distributed, according to the CDC COVID Data Tracker.
As of March 26, the U.S. had 30,219,071 confirmed COVID-19 cases resulting in 548,828 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
Comprehensive Care for Joint Replacement Model Three-Year Extension and Modifications to Episode Definition and Pricing (CMS-5529); Final Rule; Received 3/19/21
HHS Notice of Benefit and Payment Parameters for 2022 (CMS-9914); Final Rule, Received 3/24/21.
REPORTS
HHS Office of Inspector General (OIG)
On March 24, OIG released a report entitled Hospitals Reported That the COVID-19 Pandemic Has Significantly Strained Health Care Delivery. OIG found that hospitals reported that operating in "survival mode" for an extended period of time has created new and different problems than experienced earlier in the pandemic and exacerbated longstanding challenges in health care delivery, access, and health outcomes. OIG identified three key takeaways: (1) hospitals experienced difficulty balancing the complex and resource-intensive care needed for COVID-19 patients with efforts to resume routine hospital care; (2) hospitals reported a range of strategies to address their challenges and identified areas in which further government support could help as they continue responding to the pandemic; and (3) hospitals reported that longer-term opportunities for improvement to address challenges that existed before, were exacerbated by, the pandemic including reducing disparities in access to health care and in health outcomes, building and maintaining a more robust health care workforce, and responding to pandemics and other public health emergencies and disasters. A summary of the report is available here.
On March 25, OIG released a report entitled the Companion Data Services (CDC) Properly Updated Its Excess Plan Medicare Segment Pension Assets as of January 1, 2017. OIG found that CDS properly updated its Excess Plan Medicare segment pension assets from January 1, 2015, to January 1, 2017. Therefore, the $263,103 in Excess Plan Medicare segment pension assets that CDS identified as of January 1, 2017, were reasonable and correct. This report contains no recommendations. A summary of the report is available here.
HEARINGS
Both chambers are in recess until April 12.
OTHER HEALTH POLICY NEWS
On March 24, the Wyoming House of Representatives passed legislation to expand the state’s Medicaid program on a 32-28 vote, following the increase in federal funding available through the American Rescue Plan. Wyoming is the first non-expanded state to take this first step to expand the program. The legislation must still pass the state Senate and be signed by the governor.
On March 23, Kentucky Governor Andy Beshear (R) signed HB95 to cap the cost of insulin at $30 for a one-month supply. Kentucky is the 15th state to cap the cost insulin.