The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from February 22 - February 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
None of note.
Senate
On February 23, the Health, Education, Labor, and Pensions (HELP) Committee held a hearing entitled Nomination of Xavier Becerra to serve as Secretary of Health and Human Services (HHS). Becerra emphasized the need to address the COVID-19 pandemic and highlighted his experiences in Congress, including expanding the Children's Health Insurance Program (CHIP), drafting and passing the Affordable Care Act (ACA), and strengthening Medicare. Becerra committed to strengthening Medicare and Medicaid, reducing the cost of healthcare and drugs, and creating safeguards against fraud, if confirmed. A few Republicans raised concern with Becerra’s stance on abortion and religious liberty.
On February 24, the Homeland Security and Governmental Affairs Committee and Budget Committee delayed the committee’s vote on the nomination of Neera Tanden for Director of the White House Office of Management and Budget (OMB). Sens. Joe Manchin (D-WV), Susan Collins (R-ME), and Mitt Romney (R-UT) stated that they would not support Tanden’s nomination, putting her nomination in peril. Potential alternatives include Shalanda Young (current OMB Deputy Director and former Staff Directory of the House Appropriations Committee), Gene Sperling (former National Economic Council (NEC) Director), and Ann O’Leary (former Chief of Staff to Gov. Gavin Newsom’s (D-CA).
On February 24, the Finance Committee held a hearing entitled Nomination of Xavier Becerra to serve as Secretary of HHS. Becerra committed to reducing health disparities, improving public health data collection, addressing the high cost of prescription drugs, and expanding access to health care. A number of Republicans again raised concern with Becerra’s stance on abortion and religious freedom protections.
On February 25, the HELP Committee held a hearing entitled Nominations of Vivek Murthy to serve as Medical Director in the Regular Corps of the Public Health Service and Surgeon General of the Public Health Service, and Rachel Levine to serve as Assistant Secretary of HHS. Levine highlighted her efforts combating the opioid crisis, addressing youth mental health issues, supporting rural hospitals and communities, and navigating Pennsylvania through COVID-19. Murthy highlighted his experience as former Surgeon General, emphasizing the importance of science-based communications and building public trust around COVID-19 and addressing the opioid and mental health crises.
NON-CORONAVIRUS REGULATORY UPDATE
On February 22, the Department of Justice filed a motion requesting that the Supreme Court cancel arguments in the lawsuit over Medicaid work requirements, and instead allow HHS to follow the Agency’s process to revoke the 1115 demonstrations. Arkansas officials objected arguing that HHS revocation could also be subject to a legal challenge and urged the Supreme Court to continue hearing the case. Arguments are scheduled for late March.
The Food & Drug Administration (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 February 25, OMB received for review the following proposed rules from the Centers for Medicare & Medicaid Services (CMS):
Fiscal Year (FY) 2022 Skilled Nursing Facility Prospective Payment System Rate Update and Quality Reporting Requirements (CMS-1746);
FY 2022 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1750); and
FY 2022 Inpatient Rehabilitation Facility Prospective Payment System Rate Update and Quality Reporting Requirements (CMS-1748).
CORONAVIRUS UPDATE
House
On February 22, the Budget Committee held a markup and voted 19-16 to advance the American Rescue Plan Act of 2021, to the House floor. A summary of the $1.9 trillion COVID relief package is available here.
On February 23, the Energy & Commerce Oversight and Investigations Subcommittee held a hearing entitled Pathway to Protection: Expanding Availability of COVID-19 Vaccines. Representatives from Pfizer and Moderna indicated they could deliver 220 million vaccine doses by the end of March. A Johnson & Johnson (J&J) executive indicated that they could deliver 20 million doses by the end of March. Witnesses included: John Young, Group President, Chief Business Officer, Pfizer; Dr. Stephen Hoge, President, Moderna; Dr. Richard Nettles, VP of Medical Affairs, J&J; Dr. Ruud Dobber, EVP and President, AstraZeneca; John Trizzino, EVP, Chief Commercial Officer, and Chief Business Officer, Novavax. The committee background memo is available here.
On February 26, the House Ways and Means Health Subcommittee held a hearing entitled The Path Forward on COVID-19 Immunizations. Subcommittee Chair Lloyd Doggett (D-TX) called attention to challenges people are facing accessing COVID-19 vaccines and the disproportionate impact of COVID-19 on already vulnerable populations. He called for greater transparency around vaccine and treatment purchases by the federal government and also raised concern about vaccine hesitancy. Witnesses included: Ashish Jha, Dean, Brown University School of Public Health; Georges Benjamin, Executive Director, American Public Health Association; Clay Marsh, The West Virginia COVID-19 czar, Vice President, Executive Dean, West Virginia University Health Sciences; Kimberly Avila Edwards, Director of Advocacy and External Affairs; Ascension Seton Reshma Ramachandran, National Clinicians Scholar, Yale School of Medicine; Ann Lewandowski, Executive Director, Wisconsin Immunization Neighborhood.
On February 27, the House approved the American Rescue Plan Act of 2021 in a 219-212 vote.
Senate
On February 25, the Senate parliamentarian ruled that a $15-an-hour minimum wage increase, which is included in the House Budget Reconciliation bill, would violate the Senate’s Byrd Rule. As a result, Senate Democrats must drop the provision from the bill and, assuming the Senate passes a different version of the relief bill, the House would then need to pass the Senate version before it could go to President Biden for his signature. Sen. Bernie Sanders (I-VT) is attempting to save the policy by taxing employers that do not raise their minimum wage to $15 per hour, which could pass the Byrd Rule test. However, it is unclear if Sens. Manchin and Kyrsten Sinema (D-AZ), both of whom oppose increasing the minimum wage to that level, would support such a policy.
Regulatory
On February 23, the FDA issued guidance permitting smaller clinical trials to test updated COVID-19 vaccines that would protect against COVID-19 variants.
On February 23, the National Institutes of Health (NIH) launched an initiative to study the long term effects of COVID-19.
On February 25, the FDA announced that the Pfizer COVID-19 vaccine can be transported and stored at conventional temperatures commonly found in pharmaceutical freezers, instead of being held at ultra-low temperatures.
On February 27, the FDA Vaccines and Related Biological Products Advisory Committee unanimously voted to recommend J&J’s single-shot coronavirus vaccine for emergency use. On January 24, the Committee released briefing documents in favor of issuing an Emergency Use Authorization (EUA) of the J&J vaccine. The documents note that the J&J vaccine provides strong protection against severe disease and death from COVID-19 and may reduce the spread of the virus by vaccinated people. The J&J vaccine is 85% effective at preventing severe COVID-19 and 66% effective at preventing COVID-19 cases with any symptoms. On February 27, the FDA approved the EUA. The Biden Administration is expected to deliver three to four million doses of the J&J vaccine to states.
On February 26, the U.S. agreed to purchase at least 100,000 doses of Lilly’s COVID-19 antibody cocktail of bamlanivimab and etesevimab for $210 million.
On February 26, CMS, the Department of Labor, and the Department of the Treasury issued guidance to remove barriers to COVID-19 testing and vaccinations, and strengthening requirements that plans and issuers cover diagnostic testing without cost sharing. The guidance clarifies that health plans must cover COVID-19 tests for asymptomatic individuals, and for those who have no known or suspected exposure to COVID-19, without cost sharing, prior authorization, or other medical management requirements. FAQs on this guidance are available here.
White House
On February 23, the Biden Administration announced an increase of weekly COVID-19 vaccine distribution to states to 14.5 million COVID-19 vaccine doses per week, an increase from 13.5 million. The Administration is also expected to provide states with longer projections estimating expected vaccine shipments, instead of current three-week forecasts.
On February 23, Biden Administration brought on Lauren Silvis to serve as a consultant to its COVID-19 response team. Silvis served as Chief of Staff for former FDA Commissioner Scott Gottlieb, and prior to that, as Deputy Director for Policy of FDA’s Center for Devices and Radiological Health.
On February 24, President Joe Biden signed an Executive Order (EO) entitled Executive Order on America’s Supply Chains. The EO calls for a 100-day reviews of the supply chains of U.S. pharmaceuticals and active pharmaceutical ingredients (among other technologies including computer chips used in consumer products) against vulnerability including diminished capacity and reliance on foreign countries. The EO also calls for recommendations for addressing the risks to the U.S. supply chains.
On February 24, White House COVID-19 Response Coordinator Jeff Zients announced that the federal government will distribute 25 million masks to 1,300 community health centers and 60,000 food pantries and soup kitchens.
Other
On February 22, Novavax completed enrollment of its Phase III COVID-19 vaccine trial. The company expects to have data from the trial in April.
On February 22, Sanofi entered into an agreement with J&J to manufacture J&J’s COVID-19 vaccine.
On February 22, the American Clinical Laboratory Association urged Zients to close COVID-19 testing coverage loopholes and fund testing for uninsured people to ensure better access to COVID-19 testing.
On February 22, the U.K. Public Health England released preliminary results that one dose of the Pfizer COVID-19 vaccine provided high levels of protection against infection and symptomatic disease.
On February 24, Moderna finalized a modified COVID-19 vaccine to protect against COVID-19 variants and is evaluating potential third-dose boosters to protect those who’ve already received their two doses. The National Institutes of Health (NIH) is expected to begin human trials with this modified vaccine.
On February 24, Regeneron announced that the Independent Data Monitoring Committee found the COVID-19 antibody cocktail of casirivimab and imdevimab effective at reducing hospitalization and deaths. The panel recommended that Regeneron should stop enrolling patients in the placebo group for its ongoing late-stage trial.
On February 25, the Ad Council launched a Coronavirus Prevention Campaign to combat vaccine hesitancy and encourage COVID-19 vaccinations.
On February 25, Pfizer announced a Phase I trial studying a third COVID-19 vaccine dose to provide protection against emerging variants.
As of February 27, more than 48.4 million people have received the first dose of COVID-19 vaccines (nearly 23.7 million have received both doses) and more than 96.4 million doses have been distributed, according to the CDC COVID Data Tracker.
As of February 27, the U.S. had 28,554,938 confirmed COVID-19 cases resulting in 511,999 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 February 23, OIG released a report entitled Although the Bemidji Area Office (BAO) Had Adequate Procedures To Disburse Indian Health Service (his) Funds, It Needs To Strengthen Its Procedures for Monitoring the Use of the Funds. The report found that BAO generally had adequate procedures to disburse his funds to programs but monitoring did not include routine reconciliations of amounts reported in the Uniform Financial Management System (UFMS) with amounts recorded in supporting documents. OIG recommended that BAO establish procedures to reconcile IHS improper funds; monitor and evaluate IHS Direct programs' use of no-year Health Services funds carried forward by appropriation year and budget activity program; and evaluate IHS Direct programs' use of current no-year Health Services funds. A summary of the report is available here.
On February 24, OIG released a report entitled Trend Toward More Expensive Inpatient Hospital Stays in Medicare Emerged Before COVID-19 and Warrants Further Scrutiny. The report found that hospitals are increasingly billing for inpatient stays at the highest severity level, with the number of stays at the highest severity level increasing almost 20% from FY 2014 through FY 2019. OIG recommended that CMS conduct targeted reviews of Medicare Severity Diagnosis Related Groups (MS-DRGs) and stays, and hospitals that are vulnerable to upcoding. A summary of the report is available here.
On February 24, OIG released a report entitled Medicare Hospice Provider Compliance Audit: Tidewell Hospice, Inc. The report found that Tidewell did not comply with Medicare requirements for all claims, claiming reimbursement for hospice services for which the clinical record did not support the beneficiary's terminal illness prognosis or the level of care claimed and for services that were not eligible for Medicare reimbursement, at least $8.3 million in improper payments. OIG recommended that Tidewell refund the Medicare overpayments and strengthen its policies and procedures to ensure that hospice services comply with Medicare requirements. A summary of the report is available here.
On February 26, OIG released a report entitled Medicare Advantage Compliance Audit of Specific Diagnosis Codes That Blue Cross Blue Shield of Michigan (Contract H9572) Submitted to CMS. The report found that most of the selected diagnosis codes that BCBSM submitted to CMS for use in CMS' risk adjustment program did not comply with Federal requirements, resulting in at least $14.5 million of net overpayments in 2015 and 2016. OIG recommended that BCBSM refund overpayments; and examine its existing compliance procedures to identify areas where improvements can be made to ensure diagnosis codes that are at high risk for being miscoded comply with Federal requirements and take the necessary steps to enhance those procedures. A summary of the report is available here.
On February 26, the OIG released a statement by Principal Deputy Inspector General Christi Grimm stating that while OIG recognized the value of telehealth in the early days of the pandemic, they are conducting significant oversight work assessing telehealth services during the public health emergency. Once complete, the OIG will provide objective findings and recommendations that can further inform policymakers and other stakeholders considering what telehealth flexibilities should be permanent.
Government Accountability Office (GAO)
On February 24, the GAO released a report entitled COVID-19: Key Insights from GAO's Oversight of the Federal Public Health Response. The report found that out of the 16 GAO recommendations regarding COVID-19 testing, vaccines and therapeutics, the medical supply chain, COVID-19 health disparities, and COVID-19 data, only one has been fully implemented. GAO maintained that implementing these recommendations will improve the federal government's public health response and ability to recover as a nation. A summary of the report is available here.
UPCOMING HEARINGS
House
Energy and Commerce Health Subcommittee
The Future of Telehealth: How COVID-19 is Changing the Delivery of Virtual Care
March 2, 10:30 a.m., WebEx
Witnesses include: 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.
OTHER HEALTH POLICY NEWS
On February 25, the Partnership for Part D Access sent a letter, signed by over 130 patient groups, to HHS Secretary-designate Xavier Becerra urging HHS to block implementation of Trump-era changes to the CY 2022 Part D Payment Modernization (PDM) Model. As background, the Trump administration in their final hours released an RFA for year three (CY2022) of the PDM model that provided plans with flexibility around protected drug classes and the requirement to cover at least two drugs in each class.
On March 4-5, MedPAC will hold its next public meeting. The Commission will discuss 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.