The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from March 1 - March 7. 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 2, the Energy & Commerce Health Subcommittee held a hearing entitled The Future of Telehealth: How COVID-19 is Changing the Delivery of Virtual Care. Members were overwhelmingly in favor of expanding telehealth past the COVID-19 Public Health Emergency (PHE), though there were varying opinions on the details of expansion. Multiple members voiced concerns regarding potential fraud and abuse issues. Witnesses included: Megan Mahoney, M.D., Chief of Staff, Stanford Health Care; Ateev Mehrotra, M.D., Associate Professor of Health Care Policy, Harvard Medical School; Elizabeth Mitchell, President, CEO, Purchaser Business Group on Health; Jack Resneck, Jr., M.D., Board of Trustees, American Medical Association; and Frederic Riccardi, President, Medicare Rights Center. The hearing memo from Chairman Frank Pallone (D-NJ) is available here.
On March 4, Ways & Means Committee Chairman Richard Neal (D-MA) announced the creation of the Committee’s Racial Equity Initiative and appointed Reps. Terri Sewell (D-AL), Jimmy Gomez (D-CA), and Steven Horsford (D-NV) to lead the working group to address the role of racism and other forms of discrimination in perpetuating health and economic inequalities in the U.S.
Senate
On March 1, the Judiciary Committee approved the nomination of Merrick Garland as Attorney General in a 15-7 vote.
On March 3, the Finance Committee approved via a party line vote the nomination of Xavier Becerra for Health & Human Services (HHS) Secretary. Senate Majority Leader Chuck Schumer (D-NY) moved to discharge Becerra's nomination from the committee to a full floor vote.
On March 3, the Homeland Security & Governmental Affairs Committee held a hearing entitled Nominations of Shalanda D. Young to be Deputy Director, Office of Management and Budget (OMB), and Jason S. Miller to be Deputy Director for Management, OMB. Senators from both parties voiced their support for Young for the Deputy Director position and potentially for OMB Director, due to her previous bipartisan work with the House Appropriations Committee. On March 3, House Speaker Nancy Pelosi (D-CA), Majority Leader Steny Hoyer (D-MD), and Majority Whip Jim Clyburn (D-SC) issued a joint statement supporting Shalanda Young for OMB Director.
NON-CORONAVIRUS REGULATORY UPDATE
On March 1, the Centers for Medicare & Medicaid Services (CMS) announced$2.3 million in additional funding for Federal Marketplace Navigators to support states in the outreach, education and enrollment efforts around the 2021 Special Enrollment Period.
On March 1, CMS’ Center for Medicare & Medicaid Innovation (CMMI) updated its Geographic Direct Contracting Model website to note that it is reviewing the Trump-era proposal, delaying its implementation timeline and perhaps signaling that it may even be withdrawn. CMMI Director Liz Fowler previously expressedconcerns about the model.
On March 2, HHS announced additional Biden-Harris Administration appointments:
Adam Beckman for Office of the Assistant Secretary for Health Special Advisor to the Surgeon General;
Andi Fristedt for Food and Drug Administration (FDA) Deputy Commissioner for Policy;
Liz Fowler for CMS Deputy Administrator and CMMI Director;
Florence Elizabeth Lynk for Office of the Assistant Secretary for Public Affairs Deputy Assistant Secretary for Public Affairs (Health Care);
Jordan Grossman Health Resources and Services Administration Chief of Staff;
Rachel Pryor for Office of the Secretary Counselor for Health Policy;
Sabrina Bousbar for Office of the Assistant Secretary for Preparedness and Response Special Assistant (COVID Response);
Sarah Boateng for Office of the Assistant Secretary for Health Chief of Staff;
Sherice Perry for Office of Intergovernmental and External Affairs Senior Advisor for the Equity Task Force; and
Steven Hild for Office of the Assistant Secretary for Legislation Deputy Assistant Secretary for Legislation (Human Services).
On March 3, CMS reported that 206,236 Americans signed up for health insurance coverage by taking advantage of the new 2021 Marketplace Special Enrollment Period between February 15 and February 28.
On March 3, CMS released the Technical Expert Panel (TEP) 2020 Summary Report summarizing the panel’s activities, including background on the focus of each TEP meeting, a summary of the discussion, and key recommendations.
On March 5, the Agency for Healthcare Research and Quality issued a Notice of Request for Information entitled Request for Information on the Use of Clinical Algorithms that have the Potential to Introduce Racial/Ethnic Bias into Healthcare Delivery.
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:
Charles Anderson for Director of Economic Policy and Budget for the COVID-19 Response Team;
Sam Berger for Director of Strategic Operations and Policy for the COVID-19 Response Team; and
Catherine Oakar for Special Assistant to the President for Community Public Health and Disparities.
On March 2, President Biden withdrew Neera Tanden’s nomination for OMB Director.
CORONAVIRUS UPDATE
House
The House will consider the Senate Amendment to H.R. 1319, the American Rescue Plan Act of 2021, during the week of March 7.
Senate
On March 1, the Senate parliamentarian ruled that COBRA health insurance subsidies can remain in the American Rescue Plan Act of 2021 and would not violate the Senate’s Byrd Rule. Notably, the Senate bill includes a 100% COBRA subsidy, an increase from the 85% subsidy in House Bill. The Senate agreed to provide $300 a week in unemployment benefits through September 6, in addition to $10,200 in tax relief for unemployed workers with incomes under $150,000. The bill also includes $350 billion for state and local governments and $130 billion to reopen schools. On March 6, the Senate passed the nearly $2 trillion COVID relief bill. A section-by-section summary from Senate Democrats is available here. CBO’s score of the bill can be found here.
Regulatory
On March 1, FDA issued an emergency use authorization for the rapid use, antigen Quidel QuickVue At-Home COVID-19 Test.
On March 2, the National Institutes of Health (NIH) stopped its clinical trial evaluating convalescent plasma to treat mild to moderately ill COVID-19 patients in the emergency room due to a lack of evidence that it benefits this cohort.
On March 2, it was reported that the Trump administration reallocated $10 billion from the Provider Relief Fund to help health care providers pay for COVID-19-related expenses including staffing, personal protective equipment, care for uninsured patients, and vaccine distribution to fund Operation Warp Speed contracts.
On March 3, the Centers for Disease Control and Prevention (CDC) releasedupdated guidance on COVID-19 vaccination to include the Johnson & Johnson (J&J) COVID-19 vaccine. The guidance also noted that states should consider prioritizing people with disabilities or cognitive decline.
HHS will hold a COVID-19 Health Equity Task Force virtual meeting on March 26.
White House
On March 1, White House Press Secretary Jen Psaki announced that the U.S. would not consider Mexican President Andrés Manuel López Obrador’s request that the U.S. share its COVID-19 vaccine supply.
On March 2, the Biden Administration announced that Merck will manufacture doses of J&J’s COVID-19 vaccine with an investment of more than $100 million from the Administration. President Biden invoked the Defense Production Actand HHS will assist in equipping two Merck facilities to the standards necessary to safely manufacture the J&J vaccine.
On March 2, President Biden predicted that the U.S. will have enough COVID-19 vaccine for all adults by the end of May.
On March 3, White House COVID-19 Adviser Andy Slavitt announced the Vaccine Community Connectors pilot to vaccinate vulnerable and high-risk seniors, and address barriers to vaccinations, including questions about the vaccine, scheduling, and transportation.
On March 4, the NIH closed enrollment of two ACTIV-3 clinical trials for GlaxoSmithKline’s investigational monoclonal antibody therapy, VIR-7831, and Brii Biosciences’ investigational combination monoclonal antibody therapy containing BRII-196 and BRII-198.
On March 5, the White House announced two new Federal Emergency Management Agency (FEMA)-supported high volume vaccination sites in Cleveland and Atlanta.
Other
On March 2, Merck announced a clinical trial for a COVID-19 treatment, MK-7110, for severely ill COVID-19 patients.
On March 2, Governors in Texas and Mississippi issued executive orders to eliminate mask mandates and let all businesses open at 100% capacity in the respective states. President Biden and public health officials strongly disagreed with the move.
On March 4, Novartis announced that it will manufacture CureVac’s COVID-19 vaccines to accelerate production of the vaccine
On March 4, a study released in JAMA concluded that Ivermectin does not speed recovery of mild COVID-19.
As of March 6, more than 57 million people have received the first dose of COVID-19 vaccines (nearly 30 million have received both doses) and more than 116 million doses have been distributed, according to the CDC COVID Data Tracker.
As of March 6, the U.S. had 28,953,407 confirmed COVID-19 cases resulting in 524,364 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 3, OIG released a report entitled CMS Authorized Hundreds of Millions of Dollars in Advanced Premium Tax Credits on Behalf of Enrollees Who Did Not Make Their Required Premium Payments. The report found that some of the advanced premium tax credits (APTCs) made to qualified health plans (QHPs) were unallowable because they were made on behalf of enrollees who did not make their required premium payments, resulting in an estimated $950 million in unallowable payments. OIG recommended that CMS work with the Department of the Treasury and QHP issuers to recover or take other remedial action for the improper APTCs. A summary of the report is available here.
On March 1, OIG Principal Deputy Inspector General Christi A. Grimm and OIG Chief Medical Officer Julie Taitsman wrote an Op-Ed in STAT entitled Why drug prescriptions should include diagnoses.
Government Accountability Office (GAO)
On March 1, the GAO released a report entitled Medicare Part B: Payments and Use for Selected New, High-Cost Drugs. The report found that higher Medicare payments were associated with six of seven selected drugs when they were eligible for pass-through payments versus when their payments were packaged. The GAO also found differences in use for four of the seven drugs that did not have limitations on Medicare coverage. A summary of the report is available here.
On March 4, the GAO released a report entitled Drug Safety: FDA's Future Inspection Plans Need to Address Issues Presented by COVID-19 Backlog. GAO reported that the FDA conducted three foreign inspections in fiscal year (FY) 2020 following the pause due to the COVID-19 pandemic, significantly less than in recent years. During this time, the FDA has used alternative inspection tools to maintain some oversight of drug manufacturing quality but the FDA was unable to complete more than 1,000 of its planned fiscal year 2020 inspections and will likely face a backlog of inspections in future years. The GAO recommended that FDA ensure that inspection plans for future fiscal years respond to the issues presented by the backlog and that FDA fully assess the agency's alternative inspection tools. FDA concurred with both recommendations. A summary of the report is available here.
Congressional Budget Office (CBO)
On March 4, CBO released a report entitled The 2021 Long-Term Budget Outlook. The CBO found that the 2021 deficit will reach an estimated 10.3% of gross domestic product (GDP). CBO estimates that by the end of 2021, federal debt held by the public is projected to equal 102% of GDP. CBO also projects that revenues measured as a percentage of GDP will rise and spending as a percentage of GDP rises in most years in CBO’s projections. A summary of the report is available here.
UPCOMING HEARINGS
House
Appropriations Agriculture, Rural Development, FDA, and Related Agencies Subcommittee
FDA's Foreign Drug Inspections Program
March 9, 10:00 a.m., Webex
Appropriations Committee Labor, Health and Human Services, Education and Related Agencies Subcommittee
COVID-19 and the Mental Health and Substance Use Crises
March 11, 10:00 a.m., Webex
Witnesses include: 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
Senate
Health, Education, Labor & Pensions Committee
Examining Our COVID-19 Response: An Update from the Frontlines
March 9, 10:00 a.m., 106 Dirksen Senate Office Building
Witnesses include: 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.
OTHER HEALTH POLICY NEWS
On March 1, the Kaiser Family Foundation released a report entitled Limiting Private Insurance Reimbursement to Medicare Rates Would Reduce Health Spending by About $350 Billion in 2021. The analysis estimated that the total health care spending for the privately insured population would be $352 billion lower in 2021 if employers and other insurers reimbursed health care providers at Medicare rates, a 41% decrease 2021 spending projections.
On March 1, the NIHCM Foundation released a report entitled Is Health Care Shoppable? The report found that patients struggle to shop around for elective lower-limb MRI services and predicted that it is unlikely that greater cost sharing and price transparency will lead them to shop for more complex services.
On March 1, a study released in Health Affairs entitled The Affordable Care Act’s Insurance Marketplace Subsidies Were Associated With Reduced Financial Burden For US Adults found that ACA Marketplace subsidies were associated with 17% lower out-of-pocket spending and 30% lower probability of catastrophic health expenditures, among low-income adults, but middle-income adults did not experience reduced financial burden.
On March 2, a study released in the JAMA Open Network found that prescribers and patients motivated 30.4% of all branded dispensing of multisource drugs in the Medicare Part D program. Branded dispensing requested by prescribers or patients cost the program $1.67 billion and $270 million to patients when compared with switching to generics. The study recommended that policy makers consider ways to discourage prescribers and patients from requesting branded dispensing of multisource drugs because of the higher cost.
On March 3, Medicare Payment Advisory Commission (MedPAC) published a response to a recent AHIP blog post entitled Correcting the Record: Medicare Advantage costs far less than fee-for-service Medicare. The AHIP blog questioned MedPAC’s assessment that Medicare spends more overall for enrollees in Medicare Advantage (MA) than the program would have spent for similar beneficiaries enrolled in traditional fee-for-service (FFS) Medicare. MedPAC stands by its analysis and conclusions and identified problems with AHIP’s conclusions, including that calculations do not account for many of the other differences between MA and FFS spending that need to be included for an apples-to-apples comparison of MA and FFS spending.
On March 4-5, MedPAC held its March public meeting. The Commission discussed the following topics:
Congressional request: Medicare beneficiaries’ access to care in rural areas (interim report);
Mandated report on the skilled nursing facility value-based purchasing program and proposed replacement;
Streamlining CMS’s portfolio of alternative payment models;
Balancing efficiency with equity in Medicare Advantage benchmark policy;
Mandated report: Relationship between clinician services and other Medicare services;
Revising Medicare’s indirect medical education payments to better reflect teaching hospitals’ costs;
Medicare’s vaccine coverage and payment; and
Separately payable drugs in the hospital outpatient prospective payment system.