Health Care Watch: February 22, 2021
The following Health Care Watch provides a summary of legislative and regulatory health care activities from February 15 - February 21. 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 18, 19 Democratic Senators urged President Biden to urge support and fund federal grants and programs aimed at opioid and substance use disorder (SUD) prevention, treatment, harm reduction and recovery.
On February 17, Sens. Michael Bennet (D-CO) and Tim Kaine (D-VA) proposed a bill entitled Medicare-X Choice Act of 2021, that would establish a public health plan to compete with private plans. The legislation would also:
Allow for payment adjustments of up to 150% of Medicare fee-for-service rates for rural hospitals and providers;
Require marketplace plans to fully cover primary care services with no cost-sharing;
Provide a larger tax premium subsidy for Americans living below 400% of the Federal Poverty Level (FPL);
Expand eligibility of the Affordable Care Act (ACA) premium tax credit for families earning more than 400% of the FPL;
Direct the Centers for Medicare & Medicaid Services (CMS) to study the impact of covering services such as long-term services and support, home- and community-based services, assistive and enabling technologies, and vision, hearing, and dental services;
Provide additional resources to the Department of Justice and the Federal Trade Commission to take appropriate antitrust enforcement actions and address the root causes of consolidation in the health care market; and
Improve the issue of basing family's eligibility for marketplace subsidies on whether an employee's offer of workplace coverage was affordable for the individual but not necessarily affordable for the whole family, also known as the “family glitch.”
A summary of the bill is available here.
On February 19, Sen. Joe Manchin (D-WV) stated that he would not support the nomination of Neera Tanden for the Director of the White House Office of Management and Budget (OMB), citing prior comments and tweets directed towards senators. This is significant as it would mean that in order for Tanden to be confirmed, a Republican would have to vote for her nomination. Potential alternatives include former NEC Director Gene Sperling and Ann O’Leary, who was most recently Gov. Gavin Newsom’s (D-CA) Chief of Staff.
NON-CORONAVIRUS REGULATORY UPDATE
On February 16, the Food & Drug Administration (FDA) released a report entitled Reflections on a Record Year for Novel Device Innovation Despite COVID-19 Challenges. The report found that the FDA approved, cleared, or authorized 132 novel medical devices in 2020, the most in the past 40 years.
On February 16, OMB received for review a proposed rule from CMS entitled Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2022 Rates (CMS-1752).
On February 17, U.S. District Court for the Northern District of California dismissed a lawsuit from hospitals and pharmacists over drug manufacturers limitations on providing 340B discounts to contract pharmacies. The American Hospital Association, America’s Essential Hospitals, Association of American Medical Colleges, 340B Health, Children’s Hospital Association and American Society of Health System Pharmacists filed suit attempting to force the Health Resources and Services Administration (HRSA) to prohibit manufacturers from limiting 340B discounts available via contract pharmacies. The court ruled that hospitals must first take their grievances to the new 340B administrative dispute process before going to court.
On February 18, the Health & Human Services (HHS) Office of Inspector General (OIG) issued a delay of the effective date for the Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals And Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees final rule to January 1, 2023.
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 February 17, the Biden Administration announced the nomination of Chiquita Brooks-LaSure for the position of CMS Administrator. The Biden Administration will also appoint Liz Fowler for CMS’ Center for Medicare and Medicaid Innovation Director.
CORONAVIRUS UPDATE
House
The House Budget Committee will consider committee recommendations for the $1.9 trillion “American Rescue Plan” on February 22. The full House is expected to consider this package by the end of week. President Biden has stated that he wants a relief bill on his desk by mid-March.
Senate
On February 17, Sen. Manchin stated that he would not vote to overrule the Senate Parliamentarian on issues related to the Byrd Rule, which could imperil Democratic efforts to increase the minimum wage via reconciliation. It could also deal a blow to similar efforts, expected later this year, to create a public health insurance option via reconciliation.
On February 17, 23 Democratic Senators urged Senate leadership to include a 7.35% increase to the Federal Medical Assistance Percentages for Medicaid Home and Community Based Services in the next COVID-19 relief package.
Regulatory
On February 16, the Centers for Disease Control and Prevention (CDC) confirmed that there will be delays in COVID-19 vaccine distribution due to winter storms, impacting the distribution of six million doses.
On February 16, the Federal Emergency Management Agency launched its first mass COVID-19 vaccination sites in Los Angeles and Oakland.
On February 16, HHS Office of the Assistant Secretary for Preparedness and Response awarded Retractable Technologies $54.2 million for low dead space syringes necessary to extract six doses of Pfizer’s COVID-19 vaccine doses, with the potential to expand the contract to $92.7 million.
On February 16, HHS announced over 30 staff appointments, including:
Sean McCluskie as Office of the Secretary Chief of Staff;
Anne Reid as Office of the Secretary Deputy Chief of Staff; and
Arielle Woronoff as CMS Director of the Office of Legislation.
On February 17, the National Institutes of Health (NIH) announced it will evaluate the effects of remdesivir in pregnant women to treat COVID-19.
The CDC will host a virtual forum to promote confidence in COVID-19 vaccines and the equitable distribution of the shots on February 22-24.
The FDA Vaccines and Related Biological Products Advisory Committee will hold a meeting on February 26 to discuss the Emergency Use Authorization (EUA) of the Johnson & Johnson COVID-19 vaccine.
White House
On February 16, President Biden said that every American interested in receiving a COVID-19 vaccination would be able to get one by the end of July.
On February 17, President Biden announced plans to expand COVID-19 testing, improve the availability of tests, and better prepare for the threat of variants. The Administration will support the following efforts:
HHS and the Department of Defense (DoD) will invest $650 million to expand testing for K-8 schools and underserved congregate settings;
HHS and DoD will invest $815 million to increase domestic manufacturing of testing supplies; and
CDC will invest nearly $200 million to identify, track, and mitigate emerging strains of COVID-19 through genome sequencing. As part of this effort, the CDC is reported to be in discussion with at least 13 labs to expand genomic sequencing efforts.
On February 18, President Biden announced plans to contribute up to $4 billion to COVAX, the global COVID-19 initiative created to promote a more equitable distribution of COVID-19 vaccines.
Other
On February 16, Moderna reported a supply update for its COVID-19 vaccine, reporting that 45.4 million doses have been supplied to the United States.
On February 16, the FDA issued an EUA for Luminostics’ Clip COVID Rapid Antigen Test to scale-up production activities.
On February 17, a study published in the New England Journal of Medicine found that Pfizer’s COVID-19 vaccine may be 66% less effective against the COVID-19 variant from South Africa. A similar study was also published regarding the Moderna COVID-19 vaccine, finding that the protection against the variant remains to be determined.
On February 17, the U.K. approved a “human challenge” clinical trial to study the progression of COVID-19 by intentionally exposing volunteers to COVID-19, which may lead to better treatments.
On February 18, Pfizer announced a Phase II/III trial to test the safety and efficacy of the company’s COVID-19 vaccine among pregnant women .
On February 18, a study published in MedRXiv entitled FDA-authorized COVID-19 vaccines are effective per real-world evidence synthesized across a multi-state health system found that the Pfizer and Moderna COVID-19 vaccines were 88.7% effective in preventing COVID-19 and decreased hospital admission outside their respective clinical trials.
On February 18, over 200 state and national health advocacy organizations voiced support of the American Rescue Plan’s approach to improving health coverage affordability in the private market, building on the foundation of provisions in the existing health law and ensuring access to vaccines, and centering the needs of communities of color.
On February 19, a study published in The Lancet found that a single shot of the Pfizer COVID-19 vaccine is 85% effective in preventing symptomatic disease 15 to 28 days after being administered and can be stored in ordinary freezers instead of at ultracold temperatures. A summary of the study is available here.
On February 19, over 70 health advocacy groups urged Acting CMS Administrator Liz Richter to establish FQHC-specific COVID-19 vaccine administration reimbursement policies for Medicare and Medicaid.
As of February 20, over 43 million people have received the first dose of COVID-19 vaccines (over 17 million have received both doses) and more than 75 million doses have been distributed, according to the CDC COVID Data Tracker.
As of February 21, the U.S. had 28,103,951 confirmed COVID-19 cases resulting in 498,254 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
RULES AT THE WHITE HOUSE OMB
REPORTS
HHS Office of Inspector General (OIG)
On February 16, OIG released a report entitled Iowa Should Improve Its Oversight of Selected Nursing Homes' Compliance With Federal Requirements for Life Safety and Emergency Preparedness. The report found that Iowa did not ensure that selected nursing homes in the State that participated in the Medicare or Medicaid programs complied with CMS requirements for life safety and emergency preparedness, resulting in nursing home residents being at an increased risk of injury or death during a fire or other emergency. OIG recommended that Iowa correct the identified actions of the selected nursing homes, improve the standardized life safety training for nursing home staff, conduct more frequent surveys, follow-up at nursing homes with a history of multiple high-risk deficiencies, and improve the tagging of critical systems. A summary of the report is available here.
On February 16, OIG released a report entitled Comparison of Average Sales Prices and Average Manufacturer Prices: Results for the Third Quarter of 2020. The report found that in the third quarter of 2020, seven drug codes met CMS' price substitution criteria by exceeding the 5% threshold for two consecutive quarters or three of the previous four quarters. OIG provided the seven drug codes to CMS for its review and advised CMS to review this information to determine whether to pursue price substitutions that would limit excessive payments for Part B drugs. A summary of the report is available here.
Congressional Budget Office (CBO)
On February 17, the CBO released a series of cost estimates on Reconciliation Recommendations of the House Committee on Ways and Means, Reconciliation Recommendations of the House Committee on Energy and Commerce, and all other committees presenting recommendations for the Budget Resolution.
On February 18, the Congressional Budget Office (CBO) released a report entitled A Comparison of Brand-Name Drug Prices Among Selected Federal Programs. The report found that the average price of prescription drugs ranged from $118 in Medicaid to $343 in Medicare Part D. The much lower net prices in Medicaid are the result of higher manufacturer rebates in that program than in Part D. CBO also found that the average price of specialty drugs ranged from $1,889 in Medicaid to $4,293 in Part D. CBO highlighted that efforts to bring pricing down to Medicaid levels could result in higher prices to the program. A summary of the report is available here.
Government Accountability Office (GAO)
On February 17, the GAO released a report entitled Medicaid in Times of Crisis. The report combines previous GAO reports to examine how the federal government and states have used Medicaid in times of crises, including pandemics, economic recessions, national disasters, and personal health crises. GAO has recommended that Congress consider enacting automatic increases in federal Medicaid spending based on each states’ increased unemployment and decreased revenues in times of crises. Implementing this automatic, temporary change would increase federal Medicaid support in a more timely and targeted fashion.
Congressional Research Service (CRS)
On February 15, the CRS released a report entitled Overview of Health Insurance Exchanges. The report gave an overview of the various components of the health insurance exchanges, including information about the types of exchanges and their administration; eligibility and enrollment of individual and SHOP exchanges, plan costs and financial assistance available to eligible consumers and small businesses; insurer participation, and the types of enrollment assistance available to exchange consumers and federal funding for the exchanges.
UPCOMING HEARINGS
Senate
Health, Education, Labor, and Pensions Committee
Nomination of Xavier Becerra to serve as Secretary of Health and Human Services
February 23, 10:00a.m., 430 Dirksen Senate Office Building
Finance Committee
Nomination of Xavier Becerra to serve as Secretary of Health and Human Services
February 24, 2:30 p.m., 106 Dirksen Senate Office Building
Health, Education, Labor and Pensions Committee
February 25, 10:00 a.m., 430 Dirksen Senate Office Building
House
Budget Committee
Markup Of: American Rescue Plan Act of 2021
February 22, 1:00 p.m., WebEx
A summary of the Budget Reconciliation is available here.
Energy & Commerce Oversight and Investigations Subcommittee
Hearing with COVID-19 Vaccine Manufacturers
February 23, 10:30 a.m., WebEx
Witnesses: John Young, Group President, Chief Business Officer, Pfizer; Dr. Stephen Hoge, President, Moderna; Dr. Richard Nettles, VP of Medical Affairs, Johnson & Johnson; 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.
OTHER HEALTH POLICY NEWS
On February 16, the Urban Institute released a report entitled Delayed and Forgone Health Care for Nonelderly Adults during the COVID-19 Pandemic. The report found that 36% of nonelderly adults delayed or did not get care because they were worried about exposure to the coronavirus or because a health care provider limited services because of the pandemic. Nearly one-third of adults who delayed or went without care because of the pandemic reported doing so negatively affected their health, ability to work, or ability to perform other daily activities.
On February 16, a study published by the RAND Corporation entitled Impact of Policy Options for Reducing Hospital Prices Paid by Private Health Plans analyzed regulating hospital prices, improving price transparency, and increasing competition among hospitals. The study found that price regulation would have the largest impact on hospital prices and spending, compared to improving price transparency and competition, but price regulation would likely face greater political challenges.
On February 18, the Urban Institute released a report entitled Impacts of the ACA’s Medicaid Expansion on Health Insurance Coverage and Health Care Access among Young Adults. The report found that ACA Medicaid expansions increased coverage among young adults and improved access to care among those with low incomes and those ages 22 to 25 without a college degree.